Risedronate in the Prevention of Osteoporosis in Postmenopausal Women
Completed · Phase 4
Conditions studied: Osteoporosis, Postmenopausal
In brief
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.
Key facts
- Study ID
- NCT00402441
- Run by
- Sanofi
- People needed
- 260
- Starts
- 2002-09-01
- Expected to finish
- 2004-06-01
- Last updated by the study team
- 2009-04-29
Who can join
Age: 45 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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)
Where it is running
- Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
Full record on ClinicalTrials.gov
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