Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women

December 11, 2009 updated by: Sanofi

A Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Noninferiority Study Comparing 75mg Risedronate Dosed on 2 Consecutive Days Monthly With 5mg Daily Risedronate in the Treatment of Postmenopausal Osteoporosis as Assessed Over 24 Months.

To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis.

To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption.

To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1231

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

  • Argentina
      • San Isidro, Argentina
        • Sanofi-Aventis
  • Australia
      • Macquarie Park, Australia
        • Sanofi-Aventis
  • Canada
      • Laval, Canada
        • Sanofi-Aventis
  • Czech Republic
      • Prague, Czech Republic
        • Sanofi-Aventis
  • France
      • Paris, France
        • Sanofi-Aventis
  • Lebanon
      • Beirut, Lebanon
        • Sanofi-Aventis
  • Poland
      • Warszawa, Poland
        • Sanofi-Aventis
  • South Africa
      • Midrand, South Africa
        • Sanofi-Aventis
  • Turkey
      • Istanbul, Turkey
        • Sanofi-Aventis
  • United Kingdom
      • Guildford Surrey, United Kingdom
        • Sanofi-Aventis
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • 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

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Subjects meeting all of the following criteria were considered for enrollment into the study :

·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 (blood hormone tests required for subjects less than 65 years of age who had uterus removed without removal of ovaries at time of surgery).

Osteoporosis (lumbar spine T-score more than 2.5 SD below the mean value in normal young women or more than 2.0 SD below the mean value in normal young women and at least 1 fracture of a vertebra (thoracic-lumbar T4-L4)).

Exclusion Criteria:

Subjects with any of the following criteria were not considered for enrollment into the study :

·Women who have received hormone replacement therapy (with estrogen by mouth and/or progestogen and/or androgen) or raloxifene, or other bone active drugs, such as calcitonin, calcitriol/calcidiol/alfacalcidol, parathyroid hormone or any bisphosphonate within 3 months before first dose of study medication.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percent change from baseline in lumbar spine bone mineral density (BMD) at
Month 12 measured by dual-energy X-ray absorptiometry (DXA).

Secondary Outcome Measures

Outcome Measure
Efficacy:Percent change from baseline in Lumbar spine BMD at times other than Month 12, Proximal femur BMD and Bone turnover markers.
Safety: AEs, clinical laboratory values, bone biopsies.
Intact serum parathyroid hormone (PTH 1-84)before treatment and after 3, 12 and 24 months of treatment in approximately 25% of randomly selected trial participants.
Physical examination before treatment and after 12 and 24 months of treatment.

Collaborators and Investigators

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

Sponsor

Sanofi

Collaborators

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

July 1, 2004

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

July 28, 2006

First Submitted That Met QC Criteria

July 28, 2006

First Posted (ESTIMATE)

July 31, 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

  • EFC6063
  • HMR4003M/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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