Risedronate in the Prevention of Osteoporosis in Postmenopausal Women
This study has been completed.
Sponsor:
Sanofi
Collaborator:
Procter and Gamble
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00402441
First received: November 21, 2006
Last updated: April 28, 2009
Last verified: April 2009
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Purpose
Primary Objective:
- To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining bone mineral density (BMD) of the lumbar spine after 1 year of treatment in women who are non-osteoporotic and 0.5-5 years postmenopausal.
Secondary objectives:
- To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining total proximal femur, femoral neck, and trochanter BMD after 1 year of treatment in women who are 0.5-5 years postmenopausal
- To assess the general safety of 35-mg risedronate administered once weekly.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis, Postmenopausal |
Drug: Risedronate (HMR4003) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | A One-Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of 35-mg Risedronate Administered Once a Week in the Prevention of Osteoporosis in Postmenopausal Women |
Resource links provided by NLM:
MedlinePlus related topics:
Osteoporosis
Drug Information available for:
Risedronate sodium
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Percent change from baseline to Month12(endpoint) in lumbar spine BMD with imputation using LOCF principle.
Secondary Outcome Measures:
- Percent change from baseline to Months 6 and 12 in lumbar spine BMD
- and the percent change from baseline to Months 6, 12, and endpoint in total proximal femur, femoral neck, and trochanter BMD
- Reported adverse events and changes in routine clinical laboratory tests, vital signs, and physical examinations.
| Enrollment: | 260 |
| Study Start Date: | September 2002 |
| Study Completion Date: | June 2004 |
| Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
Main Inclusion/Exclusion criteria are listed hereafter:
Inclusion criteria:
- Be postmenopausal for 0.5-5 years.Menopause is defined as 12 months without menses, based on medical history. Subjects who are post-menopausal secondary to bilateral oophorectomy must have serum FSH >40 mIU/mL and estradiol <20 pg/mL.
- Subjects with 3 contiguous lumbar spine vertebral bodies (L1-L4) without fracture or degenerative disease.
- Lumbar spine BMD mean value > 0.772g/cm2 (Hologic) or >0.880 g/cm2 (Lunar).
Exclusion criteria :
- Subjects with adequate lumbar spine BMD but osteoporotic by total proximal femur BMD (<0.637 g/cm2 [Hologic]) or <0.694 g/cm2 [Lunar]) as determined by dual-energy x-ray absorptiometry (DXA)
Contacts and Locations More Information
No publications provided
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00402441 History of Changes |
| Other Study ID Numbers: | HMR4003F/4001 |
| Study First Received: | November 21, 2006 |
| Last Updated: | April 28, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Risedronic 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 23, 2013