Assessment of Pain and Quality of Life in Breast and Prostate Cancer Patients With Bone Metastases

A Multicenter, Open-label Study to Determine the Effect of iv. Zoledronic Acid on Pain and Quality of Life in Patients With Bone Metastases With or Without Skeletal Related Events (SRE) Resulting From Breast Cancer and Prostate Cancer

This study will evaluate the safety, tolerability and efficacy of zoledronic acid administered intravenously every 3-4 weeks in patients with bone metastases from either breast cancer or prostate cancer.

Inclusion criteria:

• Ambulatory patients >18 years
• Proof of breast cancer or prostate cancer
• Diagnosis of at least one cancer-related bone lesion that is detectable on conventional radiographs or bone scan at screening
• Negative pregnancy test
• ECOG performance status of 0,1 or 2

Exclusion criteria:

• Patients with abnormal renal function
• Patients with clinically symptomatic brain metastases
• Known hypersensitivity on zoledronic acid or other bisphosphonates
• Pregnancy or lactation

Other protocol-defined inclusion/exclusion criteria may apply.