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A Study of Monthly Risedronate for Osteoporosis

NCT00247273 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1294

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 single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

risedronate

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

DRUG

risedronate

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

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Sal Bartelmo, MD · P&G

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-03-31
Completion
2008-04-30

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Estonia
  • Finland
  • France
  • Hungary
  • Lebanon
  • Norway
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT00247273 on ClinicalTrials.gov