Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO

September 27, 2011 updated by: Warner Chilcott

An Extension Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO

A 2-year, Multicenter, Open-label, Phase IIIb Extension Study to Assess Bone Mineral Density and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women with Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, RVE1998080, and RVE2001079 (NCT01249261)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A 2-year, Multicenter, Open-label, Phase IIIb Extension Study to Assess Bone Mineral Density and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women with Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, RVE1998080, and RVE2001079 (NCT01249261)

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Concord, Australia
        • Research Site
  • Italy
      • Sienna, Italy
        • Research Facility
  • Poland
      • Warsaw, Poland
        • Research Facility
  • Spain
      • Barcelona, Spain
        • Research Facility
  • Sweden
      • Goteborg, Sweden
        • Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • have satisfactorily completed Clinical Study RVE2001079 (Year 8 extension study)

Exclusion Criteria:

  • Can not use any bone modifying substances except risedronate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
5 mg/day risedronate
Drug: risedronate
5 mg tablet of risedronate once a day for 2 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the safety and tolerability profile of 5 mg daily oral risedronate therapy administered for 2 years in patients with post-menopausal osteoporosis, who had received risedronate for 2 or 7 years and then had a risedronate-free year.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Warner Chilcott

Collaborators

Sanofi

Investigators

  • Study Director: Dietrich H Wenderoth, MD, Procter and Gamble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 19, 2007

First Posted (Estimate)

December 20, 2007

Study Record Updates

Last Update Posted (Estimate)

September 28, 2011

Last Update Submitted That Met QC Criteria

September 27, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2002157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postmenopausal Osteoporosis

Clinical Trials on risedronate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe