At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 7,180 enrolled
Drug / intervention
Romosozumab +2 moredrug
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, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
In Brief
A Phase 3 clinical trial evaluating Romosozumab, Placebo, and 1 other intervention for Postmenopausal Osteoporosis. Completed, enrolled 7,180 participants across 218 sites in 24 countries.
Detailed Summary
The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
CountriesArgentina, Australia, Belgium, Brazil, Canada, Colombia, Czechia, Denmark, Dominican Republic, Estonia, Germany, Hungary, India, Japan, Latvia, Lithuania, Mexico, New Zealand, Poland, Romania, Spain, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2012
First PostedApr 2012
Primary CompletionDec 2015
Study CompletionDec 2016
TodayJul 2026
First PostedApr 12, 2012
Enrollment StartMar 15, 2012
Primary CompletionDec 14, 2015
Study CompletionDec 28, 2016
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 14.2 years ago
Interventions
Romosozumabdrug
Administered by subcutaneous injection once a month (QM)
Placebodrug
Administered by subcutaneous injection once a month (QM)
Denosumabdrug
Administered by subcutaneous injection once every 6 months (Q6M)