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.