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Risedronate in Osteopenic Postmenopausal Women (OSMAUSE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345644
First Posted: June 28, 2006
Last Update Posted: December 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Procter and Gamble
Information provided by:
Sanofi
  Purpose

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.

Condition Intervention Phase
Osteoporosis Drug: risedronate Drug: risedronate placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 156
Study Start Date: March 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345644


Locations
France
Sanofi-Aventis
Paris, France
Sponsors and Collaborators
Sanofi
Procter and Gamble
Investigators
Study Director: Marie SEBILLE, Dr Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00345644     History of Changes
Other Study ID Numbers: HMR4003B_3507
EudraCT # :2005-005598-30
First Submitted: March 20, 2006
First Posted: June 28, 2006
Last Update Posted: December 7, 2009
Last Verified: December 2009

Keywords provided by Sanofi:
Postmenopausal

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Risedronate Sodium
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs