The primary objective of this study is to compare risedronate 35 mg and placebo with respect to the percent change at 12 months for distal radius trabecular bone volume (BV/TV) in osteopenic postmenopausal women, as measured by three-dimensional peripheral quantitative computed tomography (3D pQCT). The secondary objectives are to compare the percent change from Screening/Baseline between the 2 treatment groups for the following measurements: * Bone mineral density of the lumbar spine, femoral neck, femoral trochanter, and total proximal femur using a dual energy X-ray absorptiometry (DXA) scan at 12 and 24 months; * 3D pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6, 12, and 24 months; and * Bone turnover markers (BTMs) of: * fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen (CTX 1); * serum aminoterminal propeptide of type 1 procollagen (PINP); and * urine N-telopeptide cross-links (NTX) at 3, 6, 12, and 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
156
risedronate sodium 35 mg tablets (once a week dose)
placebo for risedronate tablets (once a week dose)
Sanofi-Aventis
Paris, France
Efficacy data : 3-D-pQCT Data-Microarchitectural Parameters (Distal Radius BV/TV Measurements)
Time frame: BV/TV percent change from Baseline at distal radius as measured in the non dominant wrist at Month 12
Tolerance data :collection of AEs, with special interest for upper gastrointestinal (UGI) AEs and clinical fractures
Time frame: at all visits
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