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

Postmenopausal Osteoporosis Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial Description

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00541658
Study type Interventional
Source Warner Chilcott
Contact
Status Completed
Phase Phase 3
Start date October 2007
Completion date April 2010
View Details
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