Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer

Inclusion Criteria: * Histologically proven adenocarcinoma of the prostate * Bone-scan documented metastases * Age \> 18 years * Non-controlled bone pain despite systemic anti-tumor therapy (hormone or chemotherapy) initiated at least 4 weeks before inclusion * Life expectancy \> 3 months * Written informed consent Exclusion Criteria: * New systemic anti-tumor therapy initiated less than 4 weeks before study entry or predictable need for starting a new treatment within 8 weeks * Radiation therapy on bone target lesions or bone-targeted isotope therapy (strontium or samarium) completed less than 4 weeks before study entry * Bisphosphonate therapy within 8 weeks before study entry * Abnormal renal function (serum creatinine \> 2 x the upper normal limit or creatinine clearance \< 30 ml/min) * Corrected serum calcium \> 3 mmol/L or \< 2 mmol/L * Clinically relevant hypersensitivity to zoledronic acid, or another bisphosphonate, or one component present in the formulation of the study drug * Severe concomitant medical condition that could hamper patient's quality of life or influence the interpretation of pain * Patients unable to fill in a questionnaire (neurologic or psychiatric conditions, illiteracy, etc.) Other protocol-defined exclusion criteria may apply.