Maintaining Bone Strength in Men With Prostate Cancer

An Open-Label, Randomized, Multicentre Study to Evaluate the Efficacy of Two Zoledronic Acid Schedules on Bone Mineral Density in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

The purpose of this study is to see if giving zoledronic acid three times a year is as effective as five times a year, in increasing bone strength in men with prostate cancer. All participants will receive the active drug but half will receive drug every 6 months and the other half will receive drug every 3 months. Both patient and doctor will know which treatment a patient is receiving.

After 1 year of treatment bone strength will be measured with scans and compared to the strength at the start of the study. All participants will stop receiving the drug after 1 year and will be seen back in the clinic, annually for another 2 years for follow-up.

Inclusion criteria:

Histologically confirmed diagnosis of carcinoma of the prostate

• No distant metastases
• Patients must be candidates for androgen deprivation therapy (ADT)
• Patient with a baseline BMD T-score at or below -1 standard deviations in the lumbar spine (L2-L4) are eligible

Exclusion criteria:

Patients with normal BMD at trial entry

• Patients who received any prior bisphosphonate therapy in the past 12 months
• Treatment with anti-androgen mono- or combination therapy
• Patients who are currently receiving diethylstilbesterol (DES) or who have previously received PC-SPES
• Patients who have received prior treatment with systemic corticosteroids within the past 12 months
• Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months
• Patients with any prior treatment for osteoporosis

Other protocol-defined inclusion/exclusion criteria may apply.