CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,093 enrolled
Drug / intervention
Romosozumab +3 morebiological
Likely dose
Romosozumab 210 mgfrom 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.

Search/NCT01631214
NCT01631214Phase 3Completed
CompareCT.gov

A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

Amgen·interventional·Posted Jun 29, 2012·Updated Feb 21, 2025

In Brief

A Phase 3 clinical trial evaluating Romosozumab, Alendronate, and 2 other interventions for Postmenopausal Women With Osteoporosis. Completed, enrolled 4,093 participants across 316 sites in 42 countries.

Detailed Summary

The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Women With Osteoporosis
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 29, 2012
Enrollment StartMay 4, 2012
Primary CompletionFeb 27, 2017
Study CompletionJun 29, 2017
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.0 years ago

Interventions

Romosozumabbiological

Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.

Alendronatedrug

Alendronate 70 mg tablet taken once a week

Placebo to Romosozumabdrug

Administered by subcutaneous injection once a month during the double-blind treatment phase.

Placebo to Alendronatedrug

Matching placebo tablet taken once a week during the double-blind treatment phase.