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Risedronate in Osteopenic Postmenopausal Women (OSMAUSE)

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00345644
First received: March 20, 2006
Last updated: December 4, 2009
Last verified: December 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   55 Years to 75 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345644

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

No publications provided

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
Study First Received: March 20, 2006
Last Updated: December 4, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
Postmenopausal

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Etidronic Acid
Bone Density Conservation Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013