Osteoporosis, Postmenopausal Clinical Trial
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
Verified date | April 2009 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 260 |
Est. completion date | June 2004 |
Est. primary completion date | June 2004 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Sanofi-Aventis Administrative Office | Bridgewater | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Sanofi | Procter and Gamble |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent change from baseline to Month12(endpoint) in lumbar spine BMD with imputation using LOCF principle. | |||
Secondary | Percent change from baseline to Months 6 and 12 in lumbar spine BMD | |||
Secondary | and the percent change from baseline to Months 6, 12, and endpoint in total proximal femur, femoral neck, and trochanter BMD | |||
Secondary | Reported adverse events and changes in routine clinical laboratory tests, vital signs, and physical examinations. |
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