Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases

A Phase IV Study of Zoledronic Acid Therapy in Patients With Bone Metastases From Breast Cancer or Hormone Resistant Prostate Cancer, or Bone Involvement From Multiple Myeloma, Assessing Long-term Efficacy and Safety

This study is designed to monitor the safety and efficacy of long-term treatment with zoledronic acid by assessing the incidence of, renal impairment, osteonecrosis of the jaw(ONJ), overall safety and skeletal related events (SREs) beyond 12 months treatment

Inclusion criteria:

• Documented bone metastases from breast cancer, prostate cancer or multiple myeloma
• Prior treatment with zoledronic acid for 1-2 yrs
• Life expectancy of at least 6 months

Exclusion criteria:

• Prior treatment with bisphosphonates other than zoledronic acid
• Abnormal kidney function
• Current or previous dental problems or planned dental surgery
• Pregnant or likely to become pregnant during the study

Other protocol-defined inclusion/exclusion criteria may apply