Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates (NCT NCT00936897)

NCT ID: NCT00936897

Last Updated: 2013-02-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 833 participants
• Primary outcome timeframe: Baseline to month 12
• Results posted on: 2013-02-11

Participant Flow

Participants were randomized from 29 July 2009 through 5 November 2010

Participant milestones

Measure	Denosumab 60 mg SC Q6M Denosumab 60 mg subcutaneous once every 6 months	Ibandronate 150 mg PO QM Ibandronate 150 mg oral monthly
Overall Study STARTED	417	416
Overall Study COMPLETED	398	356
Overall Study NOT COMPLETED	19	60

Reasons for withdrawal

Measure	Denosumab 60 mg SC Q6M Denosumab 60 mg subcutaneous once every 6 months	Ibandronate 150 mg PO QM Ibandronate 150 mg oral monthly
Overall Study Withdrawal by Subject	9	19
Overall Study Adverse Event	4	13
Overall Study Other	3	9
Overall Study Lost to Follow-up	1	10
Overall Study Administrative Decision	1	2
Overall Study Protocol Violation	1	1
Overall Study Ineligibility Determined	0	3
Overall Study Noncompliance	0	2
Overall Study Death	0	1

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates

Baseline characteristics by cohort

Measure	Denosumab 60 mg SC Q6M n=417 Participants Denosumab 60 mg subcutaneous once every 6 months	Ibandronate 150 mg PO QM n=416 Participants Ibandronate 150 mg oral monthly	Total n=833 Participants Total of all reporting groups
Age Continuous	67.2 Years STANDARD_DEVIATION 8.1 • n=5 Participants	66.2 Years STANDARD_DEVIATION 7.8 • n=7 Participants	66.7 Years STANDARD_DEVIATION 8 • n=5 Participants
Sex/Gender, Customized Female	417 Participants n=5 Participants	416 Participants n=7 Participants	833 Participants n=5 Participants
Sex/Gender, Customized Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	348 Participants n=5 Participants	361 Participants n=7 Participants	709 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	54 Participants n=5 Participants	42 Participants n=7 Participants	96 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to month 12

Population: All randomized subjects using regression imputation for missing post baseline data.

Outcome measures

Measure	Denosumab 60 mg SC Q6M n=417 Participants Denosumab 60 mg subcutaneous once every 6 months	Ibandronate 150 mg PO QM n=415 Participants Ibandronate 150 mg oral monthly
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12	2.2 Percentage Change From Baseline Interval 2.0 to 2.5	0.9 Percentage Change From Baseline Interval 0.6 to 1.1

SECONDARY outcome

Timeframe: Baseline to month 1

Population: Randomized subjects who enrolled in the bone marker substudy

Outcome measures

Measure	Denosumab 60 mg SC Q6M n=134 Participants Denosumab 60 mg subcutaneous once every 6 months	Ibandronate 150 mg PO QM n=113 Participants Ibandronate 150 mg oral monthly
Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1	-81.1 Percentage Change From Baseline Interval -88.0 to -70.9	-35.0 Percentage Change From Baseline Interval -51.9 to -15.3

SECONDARY outcome

Timeframe: Baseline to Month 12

Population: All randomized subjects using regression imputation for missing post baseline data

Outcome measures

Measure	Denosumab 60 mg SC Q6M n=417 Participants Denosumab 60 mg subcutaneous once every 6 months	Ibandronate 150 mg PO QM n=415 Participants Ibandronate 150 mg oral monthly
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12	1.7 Percentage Change From Baseline Interval 1.3 to 2.1	0.5 Percentage Change From Baseline Interval 0.1 to 0.9

SECONDARY outcome

Timeframe: Baseline to month 12

Population: All randomized subjects using regression imputation for missing post baseline data

Outcome measures

Measure	Denosumab 60 mg SC Q6M n=417 Participants Denosumab 60 mg subcutaneous once every 6 months	Ibandronate 150 mg PO QM n=415 Participants Ibandronate 150 mg oral monthly
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12	4.1 Percentage Change From Baseline Interval 3.7 to 4.5	2.1 Percentage Change From Baseline Interval 1.7 to 2.5

Adverse Events

Ibandronate 150 mg PO QM

Serious events: 22 serious events

Other events: 31 other events

Deaths: 0 deaths

Denosumab 60 mg SC Q6M

Serious events: 39 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ibandronate 150 mg PO QM n=410 participants at risk Ibandronate 150 mg oral monthly	Denosumab 60 mg SC Q6M n=411 participants at risk Denosumab 60 mg subcutaneous once every 6 months
Cardiac disorders Atrial fibrillation	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.49% 2/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Cardiac disorders Atrioventricular block complete	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Cardiac disorders Bradycardia	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.49% 2/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.73% 3/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Cardiac disorders Cardiac tamponade	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Cardiac disorders Coronary artery disease	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Cardiac disorders Sick sinus syndrome	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.49% 2/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Cardiac disorders Wolff-Parkinson-White syndrome	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Eye disorders Retinal detachment	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Gastrointestinal disorders Femoral hernia	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Gastrointestinal disorders Haemorrhoids	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Gastrointestinal disorders Inguinal hernia	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Gastrointestinal disorders Internal hernia	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
General disorders Chest pain	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.73% 3/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
General disorders Device failure	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
General disorders Fatigue	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Hepatobiliary disorders Hepatitis acute	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Immune system disorders Hypersensitivity	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Infections and infestations Bacterial pyelonephritis	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Infections and infestations Cellulitis	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Infections and infestations Clostridial infection	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Infections and infestations Clostridium difficile colitis	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Infections and infestations Diverticulitis	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.49% 2/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Infections and infestations Gastroenteritis	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Infections and infestations Gastroenteritis viral	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Infections and infestations Pneumonia	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Infections and infestations Pneumonia bacterial	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Infections and infestations Postoperative wound infection	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Infections and infestations Urinary tract infection	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Injury, poisoning and procedural complications Aortic injury	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Injury, poisoning and procedural complications Cardiac vein perforation	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Injury, poisoning and procedural complications Femur fracture	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Injury, poisoning and procedural complications Fracture	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Injury, poisoning and procedural complications Gun shot wound	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Injury, poisoning and procedural complications Heart injury	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Metabolism and nutrition disorders Dehydration	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Musculoskeletal and connective tissue disorders Foot deformity	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Nervous system disorders Cerebrovascular accident	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.49% 2/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Nervous system disorders Transient ischaemic attack	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.00% 0/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Psychiatric disorders Mental status changes	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Renal and urinary disorders Bladder prolapse	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Renal and urinary disorders Renal failure acute	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Surgical and medical procedures Aortic valve repair	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Vascular disorders Deep vein thrombosis	0.00% 0/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Vascular disorders Hypertension	0.24% 1/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	0.24% 1/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.

Other adverse events

Measure	Ibandronate 150 mg PO QM n=410 participants at risk Ibandronate 150 mg oral monthly	Denosumab 60 mg SC Q6M n=411 participants at risk Denosumab 60 mg subcutaneous once every 6 months
Infections and infestations Upper respiratory tract infection	2.2% 9/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	5.1% 21/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 23/410 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.	6.1% 25/411 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Participant flow includes all subjects randomized to the study. Number of subjects at risk of an adverse events are based on safety population - all randomized subjects who received at least one dose of treatment.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. 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