At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 923 enrolled
Drug / intervention
risedronate +2 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.
A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.
In Brief
A Phase 3 clinical trial evaluating risedronate for Postmenopausal Osteoporosis. Completed, enrolled 923 participants across 45 sites in 8 countries.
Detailed Summary
The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
CountriesArgentina, Belgium, Canada, Estonia, France, Hungary, Poland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedOct 2007
Primary CompletionApr 2010
TodayJul 2026
First PostedOct 10, 2007
Enrollment StartOct 1, 2007
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 18.7 years ago
Interventions
risedronatedrug
5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily
risedronatedrug
35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly
risedronatedrug
35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly