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

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

To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability

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