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

NCT00541658 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 923

Last updated 2013-04-22

Study results available
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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.

Conditions

  • Postmenopausal Osteoporosis

Interventions

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

Sponsors & Collaborators

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Ana Balske, MD, PhD · Procter and Gamble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • Estonia
  • France
  • Hungary
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00541658 on ClinicalTrials.gov