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
