Risedronate in Osteopenic Postmenopausal Women (OSMAUSE)

December 4, 2009 updated by: Sanofi

A Non-invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D Peripheral Quantitative Computed Tomography: A 24 Month, Monocenter Study Comparing Weekly Oral Risedronate 35 mg and Placebo

The primary objective of this study is to compare risedronate 35 mg and placebo with respect to the percent change at 12 months for distal radius trabecular bone volume (BV/TV) in osteopenic postmenopausal women, as measured by three-dimensional peripheral quantitative computed tomography (3D pQCT).

The secondary objectives are to compare the percent change from Screening/Baseline between the 2 treatment groups for the following measurements:

  • Bone mineral density of the lumbar spine, femoral neck, femoral trochanter, and total proximal femur using a dual energy X-ray absorptiometry (DXA) scan at 12 and 24 months;
  • 3D pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6, 12, and 24 months; and

  • Bone turnover markers (BTMs) of:

    • fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen (CTX 1);
    • serum aminoterminal propeptide of type 1 procollagen (PINP); and
    • urine N-telopeptide cross-links (NTX) at 3, 6, 12, and 24 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

156

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

  • France
      • Paris, France
        • 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

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Osteopenic, postmenopausal women, between 55 and 75 years of age with a body mass index (BMI) < 30 kg/m²

Exclusion Criteria:

  • Clinical or radiological evidence of osteoporosis
  • Severe renal impairment
  • Serum 5-hydroxy vitamin D level < 15 ng/ml
  • History of recent primary hyperparathyroidism or recent thyroid disorder
  • History of any generalized bone disease
  • Current use of glucocorticoids, estrogens, progestins, calcium supplements > 1 g/day, vitamin D supplements > 800 IU/day, parathyroid hormone (PTH), or any bisphosphonate for > 1 month at any time within the past 6 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: risedronate
risedronate sodium 35 mg tablets (once a week dose)
Placebo Comparator: 2
Drug: risedronate placebo
placebo for risedronate tablets (once a week dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy data : 3-D-pQCT Data-Microarchitectural Parameters (Distal Radius BV/TV Measurements)
Time Frame: BV/TV percent change from Baseline at distal radius as measured in the non dominant wrist at Month 12
BV/TV percent change from Baseline at distal radius as measured in the non dominant wrist at Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerance data :collection of AEs, with special interest for upper gastrointestinal (UGI) AEs and clinical fractures
Time Frame: at all visits
at all visits

Collaborators and Investigators

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

Sponsor

Sanofi

Collaborators

Procter and Gamble

Investigators

  • Study Director: Marie SEBILLE, Dr, Sanofi

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

March 1, 2006

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

March 20, 2006

First Submitted That Met QC Criteria

June 27, 2006

First Posted (Estimate)

June 28, 2006

Study Record Updates

Last Update Posted (Estimate)

December 7, 2009

Last Update Submitted That Met QC Criteria

December 4, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMR4003B_3507
  • EudraCT # :2005-005598-30

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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