A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis

Study Overview
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Brief Summary
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The study is designed to evaluate if treatment with romosozumab once a month for 12 months compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar spine. Additionally, the study will assess the effect of treatment with romosozumab for 12 months compared with placebo on BMD at the femoral neck and total hip.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis

Conditions
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Osteoporosis in Men

Intervention / Treatment
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* Biological: Romosozumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be ambulatory male subjects ≥ 55 years to ≤ 90 years of age Must have a BMD T score ≤ -2.50 at the spine or hip, or BMD T score ≤ -1.50 at the spine or hip and a history of fragility nonvertebral fracture or vertebral fracture. Exclusion Criteria: A BMD T score ≤ -3.50 at the hip, History of hip fracture Severe metabolic bone diseases Significant laboratory abnormalities Recent treatment with agents affecting bone metabolism

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Romosozumab<br>Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months. | Biological: Romosozumab<br>* Administered by subcutaneous injection once a month.<br>* Other names: EVENITY™;|
| Placebo Comparator: Placebo<br>Participants received placebo subcutaneous injections once a month for 12 months. | Drug: Placebo<br>* Administered by subcutaneous injection once a month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12 | Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in BMD at the Total Hip at Month 12 | Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and month 12 | 
| Percent Change From Baseline in BMD at the Femoral Neck at Month 12 | Femoral neck bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and month 12 | 
| Percent Change From Baseline in Lumbar Spine BMD at 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. | Baseline and month 6 | 
| Percent Change From Baseline in BMD at the Total Hip at Month 6 | Bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and month 6 | 
| Percent Change From Baseline in BMD at the Femoral Neck at Month 6 | Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis in men