CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 252 enrolled
Drug / intervention
Romosozumab +1 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.

Search/NCT01992159
NCT01992159Phase 2Completed

A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis

Amgen·interventional·Posted Nov 25, 2013·Updated Mar 25, 2019

In Brief

A Phase 2 clinical trial evaluating Romosozumab and Placebo for Postmenopausal Osteoporosis (PMO). Completed, enrolled 252 participants across 27 sites.

Detailed Summary

The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 25, 2013
Enrollment StartOct 12, 2012
Primary CompletionOct 9, 2014
Study CompletionJun 17, 2015
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 12.6 years ago

Interventions

Romosozumabdrug

Administered by subcutaneous injection

Placebodrug

Administered by subcutaneous injection