Inclusion Criteria

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.