Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter, 2 arm study. The study population will consist of prostate cancer patients with metastatic bone disease for whom androgen-deprivation therapy is planned. After stratification based on the patient's age, performance status, and severity of metastatic disease, the patients will be randomized at a 1:1 ratio to the following treatment arms: * Daily oral risedronate combined with androgen deprivation * Daily oral placebo combined with androgen deprivation Initial clinical evaluation will be performed during the 2-week screening period. While patients receive per-protocol treatment, study assessments will be performed every 4 weeks during the first 3 months, and every 12 weeks thereafter. Performance Status: Eastern Cooperative Oncology Group (ECOG) 0 to 2 Life Expectancy: At least 12 weeks Hematopoietic: * Absolute neutrophil count (ANC) \> 1,000/mm3 * Platelet count \> 100,000/mm3 * international normalized ratio (INR) \< 1.5 x upper limit of normal unless on therapeutic anticoagulation * Partial thromboplastin time (PTT) \< 1.5 x upper limit of normal unless on therapeutic anticoagulation Hepatic: * Bilirubin \< 1.5 mg/dL * Alanine transaminase (ALT) \< 2.5 x upper limit of normal Renal: * Creatinine clearance of \> 30 mL/min (by Cockcroft-Gault) Cardiovascular: * No significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, and congestive heart failure). Pulmonary: * Not specified Calcium: * Corrected serum calcium = (4.0 g/dL - actual albumin g/dL)x 0.8 + serum calcium