Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis

Inclusion Criteria: * Aged ≥18 years. * Written informed consent. * With histologically-proven prostate carcinoma. * ECOG performance status ≤ 2 * Life expectancy \> 12 months * Current or previously documented diagnosis of at least 1 bone metastasis due to prostate cancer (patient could be hormono naif, Hormono sensible or hormono refractory) * Patients with partners of childbearing potential should use a barrier method of contraception throughout the study. Exclusion Criteria: * ECOG performans status \>3 * Prior treatment with bisphosphonates IV within the last 3 month to the study * Renal insufficiency (serum creatinine \> 265 micromol/L or \> 3.0 mg/dL) * Liver function tests \> 2.5 ULN * Patients with another nonmalignant disease which would confuse the evaluation of primary endpoints or prevent the patient from complying with the protocol. * History of concomitant disease with influence on bone metabolism such as Paget's disease or primary hyperparathyroidism * Disabling or non controlled concomitant disease likely to alter the quality of life * Patient unable to fill in a questionnaire: senile dementia, psychiatric or neurological disease, illiterate or partially sighted patient * Known hypersensitivity to zoledronic acid or other bisphosphonates Other protocol-defined inclusion / exclusion criteria may apply.