Risedronate in Osteopenic Postmenopausal Women (OSMAUSE)

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ClinicalTrials.gov Identifier: NCT00345644

Recruitment Status : Completed

First Posted : June 28, 2006

Last Update Posted : December 7, 2009

Sponsor:

Collaborator:

Procter and Gamble

Information provided by:

Sanofi

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Osteoporosis	Drug: risedronate Drug: risedronate placebo	Phase 3

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	156 participants
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
Study Start Date :	March 2006
Actual Primary Completion Date :	June 2009
Actual Study Completion Date :	June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Risedronate sodium

U.S. FDA Resources

Arms and Interventions

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)

Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	55 Years to 75 Years (Adult, Older Adult)
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 Posted:	June 28, 2006 Key Record Dates
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

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