Risedronate vs Raloxifene in Hormone Replacement Therapy Discontinuation

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