Osteoporosis, Postmenopausal
Conditions
Brief summary
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.
Interventions
Sponsors
Procter and Gamble
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline to Month12(endpoint) in lumbar spine BMD with imputation using LOCF principle. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed