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

Phase 3

Completed

• Conditions: Osteoporosis in Men
• Interventions: Drug: Placebo; Biological: Romosozumab

• Registration Number: NCT02186171
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-16
• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-10
• Primary Completion: 2016-02-15
• Study Completion: 2016-04-20
• Disposition First Submitted: 2016-09-26
• Disposition First Submitted QC: 2016-09-26
• Disposition First Posted: 2016-09-27
• Status Verified: 2019-05
• Results First Submitted: 2019-05-03
• Results First Submitted QC: 2019-05-03
• Last Update Submitted: 2019-05-03
• Results First Posted: 2019-05-28
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 245

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received placebo subcutaneous injections once a month for 12 months.
Romosozumab	Romosozumab	Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12	Baseline and 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇨🇭 Zurich, Switzerland