Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

December 11, 2009 updated by: Sanofi

A Two-year, Multicenter, Double-blind, Randomized, Placebo-controlled and Parallel Group Study of Oral Risedronate 5 mg Daily in the Prevention of Osteoporosis in Osteopenic Postmenopausal Women (More Than 5 Years Postmenopausal)

To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women

To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption

To confirm general safety of 5 mg daily risedronate as compared to placebo

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

171

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

  • Finland
      • Helsinki, Finland
        • Sanofi-Aventis
  • Netherlands
      • Gouda, Netherlands
        • Sanofi-Aventis
  • Norway
      • Oslo, Norway
        • Sanofi-Aventis
  • Spain
      • Madrid, Spain
        • Sanofi-Aventis
  • Sweden
      • Stockholm, Sweden
        • Sanofi-Aventis

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Ambulatory, healthy postmenopausal women with

    • Natural menopause and more than 5 years after their last menstrual period
    • or surgical menopause and more than 5 years after surgery
    • osteopenia (lumbar spine T score between 1 and 2.5 SD below the mean value in normal young women).
  • With at least one risk factor for osteoporosis

Exclusion Criteria:

  • Women who have received hormone replacement therapy (with estrogen and/or progestogen and/or androgen) or raloxifene within 3 months before visit 2 or calcitonin or calcitriol within 4 weeks before visit 2

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA.

Secondary Outcome Measures

Outcome Measure
Percent changes in proximal femur BMD from baseline at month 12 and 24 (DXA)
Percent of responders (subjects with a positive change in lumbar spine BMD from baseline)at Month 12 and 24
Percent changes in bone turnover markers after 12 and 24 months of treatment
Physical examination and hematology tests before and after 12 and 24 months of treatment;Serum Chemistry before and after 6, 12 and 24 months of treatment
Occurrence of adverse events at each visit with special interest for upper gastro-intestinal events

Collaborators and Investigators

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

Sponsor

Sanofi

Collaborators

Procter and Gamble

Investigators

  • Principal Investigator: Välimäki Matti, MD, Division of Endocrinology, Helsinki University Central Hospital, Helsinki, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2002

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

July 13, 2006

First Submitted That Met QC Criteria

July 13, 2006

First Posted (Estimate)

July 17, 2006

Study Record Updates

Last Update Posted (Estimate)

December 15, 2009

Last Update Submitted That Met QC Criteria

December 11, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC6064
  • HMR4003B/3001

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.

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