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Risedronate in Osteopenic Postmenopausal Women (OSMAUSE)
This study has been completed.
Sponsor:
Sanofi
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
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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 Blind (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| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00345644
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
| 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 |
Keywords provided by Sanofi:
|
Postmenopausal |
Additional relevant MeSH terms:
|
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Risedronate Sodium Etidronic Acid |
Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Bone Density Conservation Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017