Overview

Maintaining Bone Strength in Men With Prostate Cancer

Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis
Treatments:
Androgens
Diphosphonates
Zoledronic Acid
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.