Risedronate vs Raloxifene in Hormone Replacement Therapy Discontinuation

Inclusion Criteria: * Postmenopausal, ambulatory females, "postmenopausal" defined as the absence of menses for at least 12 continuous months) * In general good health as determined by medical history, physical examination, and laboratory tests * LS spine BMD T-score between -1.0 and -2.4, inclusive * At least one analyzable BMD site at both the hip (left or right) and LS spine (at least 3 measurable lumbar spine vertebrae, without fracture or sufficient degenerative disease) * Currently receiving no medications for the treatment or prevention of osteoporosis * Had been on continuous HRT for at least 1 year prior to enrollment. The HRT must have ended within 18 months prior to the baseline visit, and the subject must have been off HRT medication for at least 3 months at the time of baseline visit * Subjects rendered menopausal by surgical procedures between the ages of 55 and 65 years Exclusion Criteria: * A history of cancer within 10 years prior to entry into the study, except for relatively "benign" and cured skin cancers such as basal and squamous cell carcinoma * A history of hyperparathyroidism, hyperthyroidism, osteomalacia, or other metabolic bone disease within one year prior to enrollment * Any condition or disease that may interfere with the evaluation of at least 3 lumbar vertebrae (not necessarily contiguous), determined in a screening radiograph by a radiologist at the central facility (e.g., confluent aortic calcifications, severe osteoarthritis, spinal fusion, lumbar spine fractures) * Evidence of clinically significant organic or psychiatric disease on history or physical examination, which in the opinion of the investigator would prevent the patient from completing the study * Markedly abnormal pretreatment laboratory finds that, in the opinion of the investigator, would prevent the patient from completing the study * A history of using any of the following medications prior to starting study: * Any bisphosphonate therapy * Selective estrogen receptor modulators (SERMs) * Parathyroid hormone * Fluorides * Calcitonin * Calcitriol (\>1.5 mcg/week) * Corticosteroids on a chronic basis for period equal to or greater then 3 months * Received a depot injection of \>10,000 IU Vitamin D in the past 12 months * A history of recurrent nephrolithiasis or a history of one episode of nephrolithiasis within 1 year of study entry * Serum creatinine \>1.6 mg/dl * Unable to sit or stand upright for 30 minutes after taking the morning dose of risedronate * A history of deep vein thrombosis or other coagulation disorders * Severe hepatic insufficiency * A history of hypersensitivity to raloxifene, risedronate, or to drugs with similar chemical structures * Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult * Subjects found to have one or more vertebral fractures after completing thoracic and LS spine films * Subjects who have experienced a low impact fracture related to osteopenia within two years of baseline visit The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial