NCT00541658

A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 923 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given daily.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	risedronate	5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily
DRUG	risedronate	35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly
DRUG	risedronate	35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2007-10-10
• Last updated: 2013-04-22
• Results posted: 2011-06-21

Locations

45 sites across 8 countries: United States, Argentina, Belgium, Canada, Estonia, France, Hungary, Poland