At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 245 enrolled
Drug / intervention
Romosozumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
In Brief
A Phase 3 clinical trial evaluating Romosozumab and Placebo for Osteoporosis in Men. Completed, enrolled 245 participants across 34 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis in Men
CountriesBelgium, Colombia, Czechia, Denmark, Japan, Mexico, Poland, Russia, Switzerland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJun 2014
First PostedJul 2014
Primary CompletionFeb 2016
Study CompletionApr 2016
TodayJul 2026
First PostedJul 10, 2014
Enrollment StartJun 16, 2014
Primary CompletionFeb 15, 2016
Study CompletionApr 20, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 12.0 years ago
Interventions
Romosozumabbiological
Administered by subcutaneous injection once a month.
Placebodrug
Administered by subcutaneous injection once a month.