Assessment of the 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.