Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis

Exclusion Criteria

• •Patients with known current bone disorders other than primary osteoporosis, such as hyperparathyroidism, Paget's disease, renal osteodystrophy, or osteomalacia
• •Patients experiencing clinically severe postmenopausal symptoms at the beginning of the study that require estrogen-replacement therapy
• •Patients with known, suspected, or history of carcinoma of the breast or estrogen-dependent neoplasia
• •Patients who have had any history of cancer within the previous 5 years
• •Patients with abnormal uterine bleeding
• •Patients with a history of deep venous thrombosis, thromboembolic disorders, or cerebral vascular accident within the past 10 years except for patients with a history of deep venous thrombosis due to accidents
• •Patients who have endocrine disorders requiring pharmacologic therapy except for type II diabetes
• •Patients who are not biochemically euthyroid or who have had changes in thyroid replacement therapy in the 2 months before the start of the study.
• •Patients with acute or chronic liver disease
• •Patients who have impaired kidney function
• •Patients with active renal lithiasis
• •Patients with known, severe untreated malabsorption syndromes
• •Patients with pathologic fractures (both substudies) or patients in Substudy II all of whose vertebral fractures are clearly a result of automobile accidents or other severely traumatic accidents
• •Patients in whom satisfactory baseline thoracic and lumbar x-ray views cannot be obtained
• •Patients with less than two lumbar and less than four thoracic vertebrae that are unfractured and evaluable for incident fractures
• •Treatment with therapeutic doses of any of the following medications more recently than 6 months before beginning the study: Androgen, Calcitonin, Estrogen, Progestin
• •Treatment with therapeutic doses of systemic corticosteroids for more than 1 month during the 12 months before beginning the study.
• •Patients who have received therapeutic doses of fluorides
• •Patients who have received bisphosphonate therapy for more than 14 days during the past 18 months or who have received any bisphosphonate therapy within the last 6 months before beginning the study.
• •Patients requiring high-dose heparinization (\>7500 U/day) at study entry for a total period of time that will presumably exceed 6 months
• •Patients being treated with 50,000 IU or more of vitamin D once weekly more recently than 3 months before beginning the study will be excluded.
• •Current systemic treatment with any of the following medications at the beginning of the study: Lithium, Anticonvulsants, regular use of phosphate-binding antacids.