Trial Outcomes & Findings for A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis (NCT NCT02186171)
NCT ID: NCT02186171
Last Updated: 2019-05-28
Results Overview
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
245 participants
Primary outcome timeframe
Baseline and month 12
Results posted on
2019-05-28
Participant Flow
This study was conducted at 31 centers in Europe, North America, Latin America, and Japan. Participants were enrolled from 16 June 2014 to 27 January 2015.
Participants were randomized in a 2:1 ratio to receive 210 mg romosozumab or matched placebo in a blinded fashion for the duration of the 12-month treatment period. Randomization was stratified by geographic region (Europe, North America, Latin America, and Japan).
Participant milestones
| Measure |
Placebo
Participants received placebo subcutaneous injections once a month (QM) for 12 months.
|
Romosozumab 210 mg
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
163
|
|
Overall Study
Received Treatment
|
81
|
163
|
|
Overall Study
COMPLETED
|
78
|
148
|
|
Overall Study
NOT COMPLETED
|
4
|
15
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo subcutaneous injections once a month (QM) for 12 months.
|
Romosozumab 210 mg
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
9
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Protocol-specified Criteria
|
0
|
2
|
Baseline Characteristics
A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis
Baseline characteristics by cohort
| Measure |
Placebo
n=82 Participants
Participants received placebo subcutaneous injections once a month (QM) for 12 months.
|
Romosozumab 210 mg
n=163 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.5 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
72.4 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
72.1 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Age, Customized
18 - 64 years
|
11 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Customized
65 - 74 years
|
42 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Age, Customized
75 years and over
|
29 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Race
White
|
60 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Race
Asian
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race
Other
|
13 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race
Multiple
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Geographic Region
Europe
|
54 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Geographic Region
Japan
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Geographic Region
Latin America
|
12 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Geographic Region
North America
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Lumbar Spine Bone Mineral Density T-score
|
-2.33 T-score
STANDARD_DEVIATION 1.41 • n=5 Participants
|
-2.22 T-score
STANDARD_DEVIATION 1.19 • n=7 Participants
|
-2.26 T-score
STANDARD_DEVIATION 1.27 • n=5 Participants
|
|
Total Hip BMD T-score
|
-1.92 T-score
STANDARD_DEVIATION 0.65 • n=5 Participants
|
-1.92 T-score
STANDARD_DEVIATION 0.59 • n=7 Participants
|
-1.92 T-score
STANDARD_DEVIATION 0.61 • n=5 Participants
|
|
Femoral Neck BMD T-score
|
-2.30 T-score
STANDARD_DEVIATION 0.52 • n=5 Participants
|
-2.34 T-score
STANDARD_DEVIATION 0.52 • n=7 Participants
|
-2.33 T-score
STANDARD_DEVIATION 0.52 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and month 12Population: Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the lumbar spine; last observation carried forward (LOCF) imputation was used.
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Outcome measures
| Measure |
Placebo
n=79 Participants
Participants received placebo subcutaneous injections once a month (QM) for 12 months.
|
Romosozumab 210 mg
n=157 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12
|
1.2 percent change
Standard Error 0.5 • Interval 0.5 to
|
12.1 percent change
Standard Error 0.5 • Interval 0.5 to
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the total hip; LOCF imputation was used.
Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Outcome measures
| Measure |
Placebo
n=79 Participants
Participants received placebo subcutaneous injections once a month (QM) for 12 months.
|
Romosozumab 210 mg
n=158 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in BMD at the Total Hip at Month 12
|
-0.5 percent change
Standard Error 0.3 • Interval 0.3 to
|
2.5 percent change
Standard Error 0.2 • Interval 0.2 to
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the femoral neck; LOCF imputation was used.
Femoral neck bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Outcome measures
| Measure |
Placebo
n=79 Participants
Participants received placebo subcutaneous injections once a month (QM) for 12 months.
|
Romosozumab 210 mg
n=158 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in BMD at the Femoral Neck at Month 12
|
-0.2 percent change
Standard Error 0.4 • Interval 0.4 to
|
2.2 percent change
Standard Error 0.4 • Interval 0.4 to
|
SECONDARY outcome
Timeframe: Baseline and month 6Population: Primary efficacy analysis subset with available data at baseline and month 6.
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo subcutaneous injections once a month (QM) for 12 months.
|
Romosozumab 210 mg
n=156 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine BMD at Month 6
|
0.3 percent change
Standard Error 0.4 • Interval 0.4 to
|
9.0 percent change
Standard Error 0.4 • Interval 0.4 to
|
SECONDARY outcome
Timeframe: Baseline and month 6Population: Primary efficacy analysis subset with available data at baseline and month 6.
Bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo subcutaneous injections once a month (QM) for 12 months.
|
Romosozumab 210 mg
n=157 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in BMD at the Total Hip at Month 6
|
0.2 percent change
Standard Error 0.2 • Interval 0.2 to
|
1.6 percent change
Standard Error 0.2 • Interval 0.2 to
|
SECONDARY outcome
Timeframe: Baseline and month 6Population: Primary efficacy analysis subset with available data at baseline and month 6.
Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo subcutaneous injections once a month (QM) for 12 months.
|
Romosozumab 210 mg
n=157 Participants
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Percent Change From Baseline in BMD at the Femoral Neck at Month 6
|
0.0 percent change
Standard Error 0.4 • Interval 0.4 to
|
1.2 percent change
Standard Error 0.3 • Interval 0.3 to
|
Adverse Events
Placebo
Serious events: 10 serious events
Other events: 41 other events
Deaths: 0 deaths
Romosozumab 210 mg
Serious events: 23 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=81 participants at risk
Participants received placebo subcutaneous injections once a month (QM) for 12 months.
|
Romosozumab 210 mg
n=163 participants at risk
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial flutter
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac valve disease
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
2/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Death
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Implant site haematoma
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Non-cardiac chest pain
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Atypical pneumonia
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Device related infection
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
2/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia bacterial
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
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
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
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
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
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)
Oropharyngeal cancer
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Epilepsy
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Lacunar infarction
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Syncope
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depression
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.61%
1/163 • 15 months
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
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Placebo
n=81 participants at risk
Participants received placebo subcutaneous injections once a month (QM) for 12 months.
|
Romosozumab 210 mg
n=163 participants at risk
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.5%
9/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
27.2%
22/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
21.5%
35/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.4%
6/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
8/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.9%
8/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.1%
10/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
4/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.2%
15/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
5/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
3/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
5/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
4/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
7.4%
6/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.1%
10/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
6.2%
5/81 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.6%
14/163 • 15 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER