Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer
- Patients will be randomized into 2 groups. At the screening visit, a bone mineral
density test will be performed to determine if the patient has osteoporosis or not.
Patients with osteoporosis will be treated with Zometa. Patients without osteoporosis
will be randomly assigned to receive either Zometa or a placebo.
- Zometa is administered intravenously over a 15 minute prior once in this one year
- All patients will asked to take an over-the-counter oral calcium (500mg daily) and a
daily multi-vitamin (containing 400-500 I.U of vitamin D) during the study.
- All patients will have clinic visits every 3 months for blood tests and to report any
side effects they may be experiencing. At month 12, a bone mineral density test will
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
To compare change in bone mineral density from baseline to one year between men treated with Zometa (zoledronic acid) and men treated with placebo.
Matthew Smith, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|