Trial Outcomes & Findings for Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis (NCT NCT00980174)

NCT ID: NCT00980174

Last Updated: 2018-10-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 242 participants
• Primary outcome timeframe: From Baseline to 12 Months
• Results posted on: 2018-10-17

Participant Flow

Participant milestones

Measure	Placebo	Denosumab 60 mg Q6M
Overall Study STARTED	121	121
Overall Study COMPLETED	117	111
Overall Study NOT COMPLETED	4	10

Reasons for withdrawal

Measure	Placebo	Denosumab 60 mg Q6M
Overall Study Withdrawal by Subject	1	4
Overall Study Adverse Event	0	3
Overall Study Ineligibility determined	2	1
Overall Study Death	1	1
Overall Study Other	0	1

Baseline Characteristics

Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis

Baseline characteristics by cohort

Measure	Placebo n=121 Participants	Denosumab 60 mg Q6M n=121 Participants	Total n=242 Participants Total of all reporting groups
Age, Continuous	65.0 years STANDARD_DEVIATION 9.1 • n=5 Participants	64.9 years STANDARD_DEVIATION 10.5 • n=7 Participants	65.0 years STANDARD_DEVIATION 9.8 • 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	121 Participants n=5 Participants	121 Participants n=7 Participants	242 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	107 Participants n=5 Participants	121 Participants n=7 Participants	228 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	10 Participants n=5 Participants	0 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Europe	78 Participants n=5 Participants	87 Participants n=7 Participants	165 Participants n=5 Participants
Region of Enrollment North America	43 Participants n=5 Participants	34 Participants n=7 Participants	77 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to 12 Months

Population: Subjects with baseline and at least one post baseline measurements

Outcome measures

Measure	Placebo n=118 Participants	Denosumab 60 mg Q6M n=117 Participants
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12	0.9 Percent Interval 0.3 to 1.4	5.7 Percent Interval 5.1 to 6.2

SECONDARY outcome

Timeframe: From Baseline to 12 Months

Outcome measures

Measure	Placebo n=119 Participants	Denosumab 60 mg Q6M n=117 Participants
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12	0.3 Percent Interval -0.1 to 0.7	2.4 Percent Interval 2.0 to 2.7

SECONDARY outcome

Timeframe: From Baseline to 12 Months

Outcome measures

Measure	Placebo n=119 Participants	Denosumab 60 mg Q6M n=117 Participants
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12	0.0 Percent Interval -0.6 to 0.6	2.1 Percent Interval 1.5 to 2.8

SECONDARY outcome

Timeframe: From Baseline to 12 Months

Outcome measures

Measure	Placebo n=119 Participants	Denosumab 60 mg Q6M n=117 Participants
Trochanter Bone Mineral Density Percent Change From Baseline at Month 12	0.8 Percent Interval 0.2 to 1.4	3.1 Percent Interval 2.5 to 3.7

SECONDARY outcome

Timeframe: From Baseline to 12 Months

Outcome measures

Measure	Placebo n=118 Participants	Denosumab 60 mg Q6M n=116 Participants
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12	-0.3 Percent Interval -0.8 to 0.2	0.6 Percent Interval 0.1 to 1.1

SECONDARY outcome

Timeframe: From Baseline to Day 15

Outcome measures

Measure	Placebo n=116 Participants	Denosumab 60 mg Q6M n=115 Participants
Serum Type 1 Collagen C-telopeptide (CTX) Percent Change From Baseline at Day 15	-7 Percent Interval -20.0 to 16.0	-81 Percent Interval -86.0 to -75.0

Adverse Events

Placebo

Serious events: 10 serious events

Other events: 27 other events

Deaths: 0 deaths

Denosumab 60 mg Q6M

Serious events: 11 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=120 participants at risk	Denosumab 60 mg Q6M n=120 participants at risk
Eye disorders Retinal detachment	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Acute myocardial infarction	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Atrial fibrillation	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Myocardial infarction	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Congenital, familial and genetic disorders Skull malformation	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Vitreous haemorrhage	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Pancreatitis acute	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chest pain	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholecystitis	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Injury	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Ligament rupture	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Meniscus lesion	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 3/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Basilar artery thrombosis	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebral haemorrhage	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Arterial thrombosis limb	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.7% 2/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Peripheral ischaemia	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.83% 1/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Other adverse events

Measure	Placebo n=120 participants at risk	Denosumab 60 mg Q6M n=120 participants at risk
Gastrointestinal disorders Constipation	5.8% 7/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Nasopharyngitis	5.8% 7/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.7% 8/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	5.8% 7/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.7% 8/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Back pain	6.7% 8/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.3% 10/120 • 12 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

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