Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases

Inclusion Criteria: * Age ≥ 18 years * Histological confirmed diagnosis of carcinoma of the prostate * Current or previous evidence of metastatic disease to the bone * Receiving currently or not, hormonal therapy * ECOG performance status of 0, 1, or 2 Exclusion Criteria: * Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal, or by a calculated creatinine clearance of 60 ml/minute or less. * Corrected serum calcium concentration, adjusted for serum albumin \< 8.0 mg/dl (2.00 mmol/L). * WBC\<3.0x10\^9, ANC \< 1500/mm3, Hb \< 8.0 g/dL, platelets \< 75 x 10\^9/L. * Liver function tests \>2.5 ULN, serum creatinine \>1.5 ULN. * Patients with another non malignant disease, which could confound the evaluation of primary endpoints, or prevent the patient complying with the protocol. * Known hypersensitivity to zoledronic acid or other bisphosphonates or each of the compounds which perform the formula. Other protocol-related inclusion / exclusion criteria may apply