Trial Outcomes & Findings for Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (NCT NCT01575834)

NCT ID: NCT01575834

Last Updated: 2024-08-28

Results Overview

New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method. The Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale: * Grade 0 (Normal) = no fracture; * Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); * Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; * Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 7180 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2024-08-28

Participant Flow

This study was conducted at 222 centers in Europe, Central/Latin America, Asia, North America, and Australia/New Zealand. The first participant enrolled on 15 March 2012 and the last participant enrolled on 06 December 2013.

Participants were randomized 1:1 to receive either romosozumab 210 mg or matched placebo for the 12-month, double-blind, placebo-controlled period. Randomization was stratified by age (< 75 years, ≥ 75 years) and prevalent vertebral fracture (yes, no), as determined by site staff at randomization based on local reading of the spine X-ray.

Participant milestones

Measure	Placebo/Denosumab Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.	Romosozumab/Denosumab Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
Overall Study STARTED	3591	3589
Overall Study Received Double-blind Treatment	3582	3575
Overall Study Completed Double-blind Period	3205	3185
Overall Study Completed 24-month Study Period	3032	2994
Overall Study COMPLETED	2892	2851
Overall Study NOT COMPLETED	699	738

Reasons for withdrawal

Measure	Placebo/Denosumab Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.	Romosozumab/Denosumab Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
Overall Study Withdrawal by Subject	352	390
Overall Study Death	81	74
Overall Study Other	70	70
Overall Study Adverse Event	63	61
Overall Study Lost to Follow-up	55	68
Overall Study Noncompliance	52	27
Overall Study Administrative decision	15	33
Overall Study Ineligibility Determined	5	8
Overall Study Protocol Deviation	4	3
Overall Study Requirement for Alternative Therapy	2	4

Baseline Characteristics

Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

Baseline characteristics by cohort

Measure	Placebo/Denosumab n=3591 Participants Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.	Romosozumab/Denosumab n=3589 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.	Total n=7180 Participants Total of all reporting groups
Age, Continuous	70.8 years STANDARD_DEVIATION 6.9 • n=5 Participants	70.9 years STANDARD_DEVIATION 7.0 • n=7 Participants	70.9 years STANDARD_DEVIATION 7.0 • n=5 Participants
Age, Customized < 65 years	757 Participants n=5 Participants	768 Participants n=7 Participants	1525 Participants n=5 Participants
Age, Customized ≥ 65 years	2834 Participants n=5 Participants	2821 Participants n=7 Participants	5655 Participants n=5 Participants
Sex: Female, Male Female	3591 Participants n=5 Participants	3589 Participants n=7 Participants	7180 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1416 Participants n=5 Participants	1427 Participants n=7 Participants	2843 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2175 Participants n=5 Participants	2162 Participants n=7 Participants	4337 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	2052 Participants n=5 Participants	2063 Participants n=7 Participants	4115 Participants n=5 Participants
Race/Ethnicity, Customized Asian	441 Participants n=5 Participants	425 Participants n=7 Participants	866 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	74 Participants n=5 Participants	77 Participants n=7 Participants	151 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	63 Participants n=5 Participants	64 Participants n=7 Participants	127 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	59 Participants n=5 Participants	60 Participants n=7 Participants	119 Participants n=5 Participants
Race/Ethnicity, Customized Other	901 Participants n=5 Participants	900 Participants n=7 Participants	1801 Participants n=5 Participants
Prevalent Vertebral Fracture Strata per Randomization Yes	205 Participants n=5 Participants	204 Participants n=7 Participants	409 Participants n=5 Participants
Prevalent Vertebral Fracture Strata per Randomization No	3386 Participants n=5 Participants	3385 Participants n=7 Participants	6771 Participants n=5 Participants
Age Strata per Randomization < 75 years	2471 Participants n=5 Participants	2470 Participants n=7 Participants	4941 Participants n=5 Participants
Age Strata per Randomization ≥ 75 years	1120 Participants n=5 Participants	1119 Participants n=7 Participants	2239 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 12 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used.

New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method.

The Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale:

• Grade 0 (Normal) = no fracture;
• Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);
• Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;
• Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.

Outcome measures

Measure	Placebo n=3322 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3321 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percentage of Participants With New Vertebral Fracture Through Month 12	1.8 percentage of participants	0.5 percentage of participants

PRIMARY outcome

Timeframe: 24 months

Population: Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used.

New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method.

The Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale:

• Grade 0 (Normal) = no fracture;
• Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);
• Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;
• Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.

Outcome measures

Measure	Placebo n=3327 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3325 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percentage of Participants With New Vertebral Fracture Through Month 24	2.5 percentage of participants	0.6 percentage of participants

SECONDARY outcome

Timeframe: 12 Months

Population: Full analysis set; Last observation carried forward imputation (LOCF) was used.

Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.

Outcome measures

Measure	Placebo n=3591 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3589 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percentage of Participants With a Clinical Fracture Through Month 12	2.5 percentage of participants	1.6 percentage of participants

SECONDARY outcome

Timeframe: 12 Months

Population: Full analysis set

A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.

Outcome measures

Measure	Placebo n=3591 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3589 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percentage of Participants With a Nonvertebral Fracture Through Month 12	2.1 percentage of participants	1.6 percentage of participants

SECONDARY outcome

Timeframe: 24 Months

Population: Full analysis set

A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date as recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.

Outcome measures

Measure	Placebo n=3591 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3589 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percentage of Participants With a Nonvertebral Fracture Through Month 24	3.6 percentage of participants	2.7 percentage of participants

SECONDARY outcome

Timeframe: 24 Months

Population: Full analysis set; LOCF imputation was used

Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.

Outcome measures

Measure	Placebo n=3591 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3589 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percentage of Participants With a Clinical Fracture Through Month 24	4.1 percentage of participants	2.8 percentage of participants

SECONDARY outcome

Timeframe: 12 Months

Population: Full analysis set

A major nonvertebral fracture was a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.

Outcome measures

Measure	Placebo n=3591 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3589 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percentage of Participants With a Major Nonvertebral Fracture Through Month 12	1.5 percentage of participants	1.0 percentage of participants

SECONDARY outcome

Timeframe: 24 Months

Population: Full analysis set

A major nonvertebral fracture was a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.

Outcome measures

Measure	Placebo n=3591 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3589 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percentage of Participants With a Major Nonvertebral Fracture Through Month 24	2.8 percentage of participants	1.9 percentage of participants

SECONDARY outcome

Timeframe: 12 Months

Population: Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. LOCF imputation was used

A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4.

Outcome measures

Measure	Placebo n=3322 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3321 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 12	1.8 percentage of participants	0.5 percentage of participants

SECONDARY outcome

Timeframe: 24 Months

Population: Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. LOCF imputation was used.

A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4.

Outcome measures

Measure	Placebo n=3327 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3325 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24	2.5 percentage of participants	0.7 percentage of participants

SECONDARY outcome

Timeframe: 12 Months

Population: Full analysis set

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.

Outcome measures

Measure	Placebo n=3591 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3589 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percentage of Participants With a Hip Fracture Through Month 12	0.4 percentage of participants	0.2 percentage of participants

SECONDARY outcome

Timeframe: 24 Months

Population: Full analysis set

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.

Outcome measures

Measure	Placebo n=3591 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3589 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percentage of Participants With a Hip Fracture Through Month 24	0.6 percentage of participants	0.3 percentage of participants

SECONDARY outcome

Timeframe: 12 Months

Population: Full analysis set

Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.

Outcome measures

Measure	Placebo n=3591 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3589 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percentage of Participants With a Major Osteoporotic Fracture Through Month 12	1.8 percentage of participants	1.1 percentage of participants

SECONDARY outcome

Timeframe: 24 Months

Population: Full analysis set

Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.

Outcome measures

Measure	Placebo n=3591 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3589 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percentage of Participants With a Major Osteoporotic Fracture Through Month 24	3.1 percentage of participants	1.9 percentage of participants

SECONDARY outcome

Timeframe: 12 Months

Population: Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. LOCF imputation was used.

A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit.

Outcome measures

Measure	Placebo n=3322 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3321 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 12	0.3 percentage of participants	0.03 percentage of participants

SECONDARY outcome

Timeframe: 24 Months

Population: Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. LOCF imputation was used.

A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit.

Outcome measures

Measure	Placebo n=3327 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3325 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24	0.5 percentage of participants	0.03 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Outcome measures

Measure	Placebo n=3148 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3151 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12	0.4 percent change Standard Error 0.1	13.1 percent change Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Outcome measures

Measure	Placebo n=2877 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=2861 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percent Change From Baseline In Bone Mineral Density at the Lumbar Spine at Month 24	5.5 percent change Standard Error 0.1	16.6 percent change Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Outcome measures

Measure	Placebo n=3210 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3197 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 12	0.3 percent change Standard Error 0.1	6.0 percent change Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Outcome measures

Measure	Placebo n=2918 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=2903 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24	3.2 percent change Standard Error 0.1	8.5 percent change Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Outcome measures

Measure	Placebo n=3210 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=3197 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 12	0.3 percent change Standard Error 0.1	5.5 percent change Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Outcome measures

Measure	Placebo n=2918 Participants Participants received placebo subcutaneous injections once a month for 12 months.	Romosozumab n=2903 Participants Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.
Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 24	2.3 percent change Standard Error 0.1	7.3 percent change Standard Error 0.1

Adverse Events

12-Month Double-blind Period: Placebo

Serious events: 314 serious events

Other events: 2059 other events

Deaths: 0 deaths

12-Month Double-blind Period: Romosozumab

Serious events: 344 serious events

Other events: 2019 other events

Deaths: 0 deaths

36-Month Study Period: Placebo/Denosumab

Serious events: 733 serious events

Other events: 2434 other events

Deaths: 0 deaths

36-Month Study Period: Romosozumab/Denosumab

Serious events: 728 serious events

Other events: 2463 other events

Deaths: 0 deaths

Serious adverse events

Measure	12-Month Double-blind Period: Placebo n=3576 participants at risk Participants received placebo subcutaneous injections once a month for 12 months	12-Month Double-blind Period: Romosozumab n=3581 participants at risk Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.	36-Month Study Period: Placebo/Denosumab n=3576 participants at risk Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.	36-Month Study Period: Romosozumab/Denosumab n=3581 participants at risk Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Anaemia	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 9/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Anaemia of chronic disease	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Aplastic anaemia	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Coagulopathy	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Hypocoagulable state	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Iron deficiency anaemia	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Lymphadenitis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Pernicious anaemia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Acute coronary syndrome	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Acute myocardial infarction	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.28% 10/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.45% 16/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Adams-Stokes syndrome	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Angina pectoris	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Angina unstable	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 9/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.28% 10/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve disease mixed	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve stenosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Arrhythmia	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrial fibrillation	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 18/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.47% 17/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrioventricular block	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrioventricular block complete	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Bradycardia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac arrest	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.28% 10/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure acute	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure chronic	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure congestive	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.22% 8/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.28% 10/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiogenic shock	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiopulmonary failure	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Congestive cardiomyopathy	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cor pulmonale	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery disease	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery insufficiency	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery stenosis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Heart valve incompetence	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Hypertensive heart disease	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Low cardiac output syndrome	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Mitral valve prolapse	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Mitral valve stenosis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Myocardial infarction	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 9/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.22% 8/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Myocardial ischaemia	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Palpitations	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Paroxysmal atrioventricular block	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Prinzmetal angina	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Sinus bradycardia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Sinus node dysfunction	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Stress cardiomyopathy	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Supraventricular tachycardia	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Ventricular tachycardia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Congenital, familial and genetic disorders Dermoid cyst	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Acute vestibular syndrome	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Hypoacusis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Meniere's disease	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Vertigo	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Vertigo positional	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Vestibular ataxia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Goitre	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Hyperthyroidism	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Primary hyperaldosteronism	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Age-related macular degeneration	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Angle closure glaucoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Blindness unilateral	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Cataract	0.14% 5/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.39% 14/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.36% 13/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Cystoid macular oedema	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Glaucoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Lens disorder	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Posterior capsule rupture	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Retinal detachment	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Retinal disorder	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Uveitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal adhesions	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal hernia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal incarcerated hernia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 9/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.28% 10/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain upper	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Acute abdomen	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Anal fissure	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Anal prolapse	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Chronic gastritis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Coeliac disease	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Colitis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Colitis ischaemic	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Constipation	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diverticular perforation	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diverticulum	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Dyspepsia	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Dysphagia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Enteritis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Faecaloma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Femoral hernia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Fistula of small intestine	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Functional gastrointestinal disorder	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastric polyps	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastric ulcer	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastric ulcer perforation	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastritis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal angiodysplasia	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal hypomotility	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal necrosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Hernial eventration	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Hiatus hernia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Ileus	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Ileus paralytic	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Incarcerated umbilical hernia	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Inguinal hernia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intestinal ischaemia	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intestinal obstruction	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intestinal perforation	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Large intestinal ulcer	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Large intestine perforation	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Large intestine polyp	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Mechanical ileus	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Melaena	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Mesenteric artery thrombosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Nausea	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatic cyst	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatic cyst rupture	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatic fistula	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatitis acute	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatitis chronic	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Peritoneal adhesions	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Rectal prolapse	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Reflux gastritis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Toothache	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Umbilical hernia	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Vomiting	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Asthenia	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest pain	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Complication associated with device	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Death	0.14% 5/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 9/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.36% 13/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders General physical health deterioration	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Malaise	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Medical device discomfort	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Mucosal dryness	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Multiple organ dysfunction syndrome	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Non-cardiac chest pain	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.28% 10/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Oedema peripheral	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pyrexia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Sudden death	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Bile duct stone	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Biliary colic	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Biliary dilatation	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholangitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholangitis sclerosing	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholecystitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholecystitis acute	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholelithiasis	0.22% 8/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.31% 11/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.34% 12/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholelithiasis obstructive	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholestasis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Hepatic cyst	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Hepatic failure	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Hepatocellular injury	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Ischaemic hepatitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Jaundice	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Liver disorder	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Liver injury	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Portal hypertension	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Sphincter of Oddi dysfunction	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Anaphylactic shock	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Drug hypersensitivity	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Hypersensitivity	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abdominal sepsis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abscess	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abscess limb	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Amoebiasis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Amoebic colitis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Amoebic dysentery	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Appendicitis	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Appendicitis perforated	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Arthritis bacterial	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bacterial tracheitis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 9/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis bacterial	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis viral	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cellulitis	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.31% 11/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.31% 11/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Chikungunya virus infection	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Chlamydial infection	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Chronic sinusitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Clostridium colitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Clostridium difficile colitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cystitis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Dengue fever	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Dermatitis infected	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Diverticulitis	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Empyema	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Encephalitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Enterobacter bacteraemia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Erysipelas	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Escherichia sepsis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Escherichia urinary tract infection	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Eye infection	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gangrene	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis bacterial	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis viral	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Hepatitis B	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Hepatitis C	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Hepatitis viral	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Herpes zoster	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Infected dermal cyst	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Infected skin ulcer	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Infective exacerbation of bronchiectasis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Influenza	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Intestinal gangrene	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Labyrinthitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Liver abscess	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Lower respiratory tract infection	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Lyme disease	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Lymphangitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Medical device site joint infection	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Meningitis pneumococcal	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Mycobacterium avium complex infection	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Osteomyelitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Osteomyelitis chronic	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Otitis media acute	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Perichondritis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Perineal abscess	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Perirectal abscess	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Peritonitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Peritonitis bacterial	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pharyngitis bacterial	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Phlebitis infective	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumococcal sepsis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia	0.28% 10/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 19/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.0% 37/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.2% 44/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia bacterial	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia cryptococcal	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia haemophilus	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia mycoplasmal	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Postoperative wound infection	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pulmonary sepsis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pulmonary tuberculosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyelocystitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyelonephritis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyelonephritis acute	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyometra	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyonephrosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Salmonellosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sepsis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Septic shock	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sinusitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Skin infection	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Staphylococcal infection	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Streptococcal sepsis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Tick-borne viral encephalitis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Ureteritis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	0.20% 7/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.39% 14/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.47% 17/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection bacterial	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urosepsis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Vaginitis bacterial	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Vestibular neuronitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Wound abscess	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Animal bite	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Cataract operation complication	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Concussion	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Contusion	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Craniocerebral injury	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Eye injury	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Eyelid injury	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Face injury	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fall	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Femoral neck fracture	0.22% 8/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.39% 14/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.31% 11/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Femur fracture	0.20% 7/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 19/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 9/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fibula fracture	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.22% 8/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Foreign body	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Hand fracture	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Head injury	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.22% 8/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.22% 8/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Injury	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Internal injury	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Joint dislocation	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Joint injury	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Limb injury	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Meniscus injury	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Overdose	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Patella fracture	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Post concussion syndrome	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Postoperative adhesion	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Postoperative delirium	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Procedural hypotension	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Radial head dislocation	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Radius fracture	0.14% 5/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.48% 17/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.39% 14/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Rib fracture	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Stoma site ischaemia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Subdural haematoma	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Tibia fracture	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Ulna fracture	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.34% 12/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.22% 8/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Uterine dehiscence	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Wound	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Wound complication	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Wound evisceration	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Wound haemorrhage	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Wound necrosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood lactic acid increased	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood pressure decreased	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood pressure increased	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Body mass index increased	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Fibrin D dimer increased	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Gastric pH decreased	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations General physical condition abnormal	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Haemoglobin decreased	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Hepatic enzyme increased	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Influenza B virus test positive	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Liver function test increased	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Transaminases increased	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Dehydration	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Folate deficiency	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperkalaemia	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypoglycaemia	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypokalaemia	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyponatraemic syndrome	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypoosmolar state	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Malnutrition	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Mineral metabolism disorder	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthralgia	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Fracture pain	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Meniscal degeneration	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteitis deformans	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.42% 15/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.76% 27/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.59% 21/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.28% 10/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Trigger finger	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acral lentiginous melanoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.22% 8/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal neoplasm	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiocentric lymphoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.14% 5/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous carcinoma	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign gastric neoplasm	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of adrenal gland	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of spinal cord	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign pleural neoplasm	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign soft tissue neoplasm	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.31% 11/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.22% 8/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage III	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage II	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Choroid melanoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrous histiocytoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Granular cell tumour	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraocular melanoma	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine benign neoplasm	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.17% 6/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.28% 10/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.36% 13/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of conjunctiva	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma benign	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to pleura	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal cancer	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm of appendix	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurofibroma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma recurrent	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer metastatic	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paget's disease of nipple	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancoast's tumour	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neuroendocrine tumour	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paranasal sinus benign neoplasm	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phaeochromocytoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pyogenic granuloma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer stage II	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal adenoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine adenocarcinoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of pharynx	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the hypopharynx	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tracheal cancer	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Amyotrophic lateral sclerosis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Arachnoid cyst	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Basal ganglia stroke	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Brain oedema	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Brain stem ischaemia	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Carotid arteriosclerosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Carotid artery occlusion	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Carotid artery stenosis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebellar ischaemia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral haematoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral haemorrhage	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral infarction	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral ischaemia	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebrovascular accident	0.20% 7/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 9/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.39% 14/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebrovascular disorder	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cervical myelopathy	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cervical radiculopathy	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cervicogenic headache	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cognitive disorder	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dementia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dementia Alzheimer's type	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Depressed level of consciousness	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Diabetic coma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dizziness	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Embolic cerebral infarction	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Epilepsy	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Facial paralysis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Facial paresis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Haemorrhage intracranial	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Haemorrhagic cerebral infarction	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Haemorrhagic stroke	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Haemorrhagic transformation stroke	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hemiparesis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hemiplegia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hepatic encephalopathy	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hydrocephalus	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hypotonia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Internal carotid artery kinking	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Intracranial aneurysm	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Ischaemic stroke	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 9/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.36% 13/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Lacunar infarction	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Loss of consciousness	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Lumbosacral radiculopathy	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Meralgia paraesthetica	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Migraine	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Motor dysfunction	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Multiple sclerosis relapse	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Nerve compression	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Nerve root compression	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Neuropathy peripheral	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Normal pressure hydrocephalus	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Nystagmus	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Paraesthesia	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Paralysis recurrent laryngeal nerve	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Paresis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Parkinson's disease	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Polyneuropathy	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Post herpetic neuralgia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Post-traumatic headache	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Ruptured cerebral aneurysm	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Sciatica	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Seizure	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Somnolence	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Stupor	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Syncope	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 9/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Tension headache	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Transient ischaemic attack	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.36% 13/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Tremor	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Trigeminal neuralgia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Vascular encephalopathy	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Product Issues Device dislocation	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Product Issues Device malfunction	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Affective disorder	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Alcoholism	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Anxiety	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Anxiety disorder	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Bipolar I disorder	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Bipolar disorder	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Confusional state	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Delirium	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Depression	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Hallucination	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Major depression	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Mental status changes	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Personality change due to a general medical condition	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Pseudodementia	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Psychotic disorder	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Schizophreniform disorder	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Suicide attempt	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Transient psychosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Acute kidney injury	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Acute prerenal failure	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Calculus urinary	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Chronic kidney disease	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Haematuria	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Hydrocalyx	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Hydronephrosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Nephrolithiasis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal failure	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal impairment	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal infarct	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal injury	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Stress urinary incontinence	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Ureteric perforation	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Ureterolithiasis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urinary incontinence	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urinary retention	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urinary tract inflammation	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Cervical dysplasia	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Cervical polyp	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Cystocele	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Endometrial hypertrophy	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Fibrocystic breast disease	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Ovarian cyst	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Pelvic haematoma	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Pelvic prolapse	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Rectocele	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Urogenital prolapse	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Uterine polyp	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Uterovaginal prolapse	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Vaginal haematoma	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Vaginal polyp	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Alveolitis allergic	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Asthma	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.22% 8/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Choking sensation	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.42% 15/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.78% 28/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.61% 22/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 9/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Sinus polyp	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Vocal cord cyst	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Dermatitis exfoliative	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Granuloma annulare	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Lichen sclerosus	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin disorder	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin necrosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Social circumstances Activities of daily living impaired	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Social circumstances Immobile	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Cardiac pacemaker replacement	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Cataract operation	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Hysterectomy	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Knee arthroplasty	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Osteosynthesis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Pulmonary resection	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Rehabilitation therapy	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Scar excision	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Aortic aneurysm	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Aortic thrombosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Arterial occlusive disease	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Arterial stenosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Arteriosclerosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Circulatory collapse	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Deep vein thrombosis	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Dry gangrene	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Extremity necrosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertension	0.14% 5/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.22% 8/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.34% 12/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.42% 15/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertensive crisis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertensive emergency	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypotension	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypovolaemic shock	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Pelvic venous thrombosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral arterial occlusive disease	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral artery occlusion	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral artery stenosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral artery thrombosis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral ischaemia	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Shock haemorrhagic	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Thrombophlebitis	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Thrombophlebitis superficial	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Varicose ulceration	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Varicose vein	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Vascular insufficiency	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Vasculitis	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Venous thrombosis limb	0.00% 0/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Other adverse events

Measure	12-Month Double-blind Period: Placebo n=3576 participants at risk Participants received placebo subcutaneous injections once a month for 12 months	12-Month Double-blind Period: Romosozumab n=3581 participants at risk Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.	36-Month Study Period: Placebo/Denosumab n=3576 participants at risk Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.	36-Month Study Period: Romosozumab/Denosumab n=3581 participants at risk Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
Musculoskeletal and connective tissue disorders Arthralgia	12.1% 434/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	13.1% 468/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	18.5% 663/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	18.7% 668/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	10.6% 380/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.4% 373/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.0% 573/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.5% 518/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Constipation	4.5% 162/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.9% 138/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 210/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.3% 189/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	3.7% 133/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.1% 111/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.3% 191/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.1% 182/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Influenza	5.0% 180/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.7% 169/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.7% 240/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.6% 237/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Nasopharyngitis	12.3% 439/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.8% 460/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	17.4% 622/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	18.2% 651/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	4.8% 172/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 161/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 255/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.6% 236/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	4.0% 142/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.6% 130/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.4% 263/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 244/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Viral upper respiratory tract infection	6.3% 227/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.8% 206/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.4% 263/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.4% 230/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Contusion	3.4% 122/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.8% 102/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.7% 204/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 179/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fall	8.9% 319/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 255/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	15.1% 539/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	13.5% 484/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscle spasms	3.9% 140/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.6% 163/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.6% 201/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 211/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.8% 172/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.7% 168/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.3% 260/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.3% 263/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteoarthritis	5.9% 210/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.1% 184/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.2% 329/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.0% 321/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pain in extremity	8.4% 299/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.8% 278/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 407/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.6% 417/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dizziness	4.4% 158/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.3% 154/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.0% 216/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.4% 228/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	5.8% 206/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.6% 235/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.6% 270/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	8.2% 293/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Cough	3.3% 117/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.6% 130/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 179/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.3% 189/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertension	7.3% 260/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.1% 219/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.5% 411/3576 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.7% 384/3581 • Double-blind treatment period: 12 months; Overall study: 36 months Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

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Restriction type: OTHER