CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,294 enrolled
Drug / intervention
risedronate +1 moredrug
Likely dose
risedronate 5 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/NCT00247273
NCT00247273Phase 3Completed

A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)

Warner Chilcott·interventional·Posted Nov 1, 2005·Updated Apr 22, 2013

In Brief

A Phase 3 clinical trial evaluating risedronate for Postmenopausal Osteoporosis. Completed, enrolled 1,294 participants across 49 sites in 14 countries.

Detailed Summary

The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Belgium, Brazil, Canada, Estonia, Finland, France, Hungary, Lebanon, Norway, Poland, Spain, United States
CollaboratorsSanofi

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 1, 2005
Enrollment StartOct 1, 2005
Primary CompletionMar 1, 2008
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 20.7 years ago

Interventions

risedronatedrug

tablet, 5 mg risedronate, once a day for 2 years

risedronatedrug

oral, 150 mg risedronate, once a month for 2 years