Study Complete
Sponsor ID
20110174
A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) versus Placebo in Men with OsteoporosisBRIDGE
Study Details
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.
Protocol Summary
Primary Outcome Measures
Percent change from baseline in DXA BMD at the lumbar spine at Month 12
Timeframe: 12 Months
Secondary Outcome Measures
Percent change from baseline in DXA BMD at the femoral neck and total hip at Month 12.
Timeframe: 12 Months
Percent change from baseline in DXA BMD at the lumbar spine, femoral neck, and total hip at Month 6.
Timeframe: Month 6
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Bethesda, MD, United States, 20817
Status
Recruiting
Location
Research Site
Lakewood, CO, United States, 80227
Status
Recruiting
Location
Research Site
Shinagawa-ku, Tokyo, Japan, 140-0011
Status
Recruiting
Location
Research Site
Albuquerque, NM, United States, 87106
Status
Recruiting
Location
Research Site
Bungoono-shi, Oita, Japan, 879-7125
Status
Recruiting
Location
Research Site
Mizunami-shi, Gifu, Japan, 509-6134
Status
Recruiting
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