To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis. To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption. To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,231
Sanofi-Aventis
Bridgewater, New Jersey, United States
Sanofi-Aventis
San Isidro, Argentina
Sanofi-Aventis
Macquarie Park, Australia
Sanofi-Aventis
Laval, Canada
Sanofi-Aventis
Prague, Czechia
Sanofi-Aventis
Paris, France
Sanofi-Aventis
Beirut, Lebanon
Sanofi-Aventis
Warsaw, Poland
Sanofi-Aventis
Midrand, South Africa
Sanofi-Aventis
Istanbul, Turkey (Türkiye)
...and 1 more locations
Percent change from baseline in lumbar spine bone mineral density (BMD) at
Month 12 measured by dual-energy X-ray absorptiometry (DXA).
Efficacy:Percent change from baseline in Lumbar spine BMD at times other than Month 12, Proximal femur BMD and Bone turnover markers.
Safety: AEs, clinical laboratory values, bone biopsies.
Intact serum parathyroid hormone (PTH 1-84)before treatment and after 3, 12 and 24 months of treatment in approximately 25% of randomly selected trial participants.
Physical examination before treatment and after 12 and 24 months of treatment.
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