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.

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.