Risedronate in Osteopenic Postmenopausal Women (OSMAUSE)

A Non-invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D Peripheral Quantitative Computed Tomography: A 24 Month, Monocenter Study Comparing Weekly Oral Risedronate 35 mg and Placebo

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.

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

Inclusion Criteria: Osteopenic, postmenopausal women, between 55 and 75 years of age with a body mass index (BMI) < 30 kg/m² Exclusion Criteria: Clinical or radiological evidence of osteoporosis Severe renal impairment Serum 5-hydroxy vitamin D level < 15 ng/ml History of recent primary hyperparathyroidism or recent thyroid disorder History of any generalized bone disease Current use of glucocorticoids, estrogens, progestins, calcium supplements > 1 g/day, vitamin D supplements > 800 IU/day, parathyroid hormone (PTH), or any bisphosphonate for > 1 month at any time within the past 6 months. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.