Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation
Osteoporosis, Prostate Cancer
About this trial
This is an interventional supportive care trial for Osteoporosis focused on measuring osteoporosis, stage III prostate cancer, stage IV prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer Stage III or IV disease Received at least 3 months of prior androgen deprivation therapy (no maximum amount/time) by either surgical or medical castration Medical castration may be by intermittent or continuous androgen suppression via single- or combined-drug androgen blockade Continued concurrent androgen deprivation therapy required throughout study participation No bone metastases by baseline bone scan PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 1 year Hematopoietic Not specified Hepatic Bilirubin less than 3 times upper limit of normal (ULN) AST and ALT less than 3 times ULN No chronic liver disease Renal Creatinine no greater than 2.0 mg/dL Other Fertile patients must use effective contraception No Paget's disease No Cushing's disease No hyperthyroidism No hyperprolactinemia PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Prior chemotherapy for prostate cancer allowed Endocrine therapy See Disease Characteristics More than 12 months since prior suppressive doses of thyroxine or calcitonin More than 6 months since prior corticosteroids Concurrent corticosteroids allowed (after enrollment on study) Radiotherapy Prior radiotherapy for prostate cancer allowed Surgery See Disease Characteristics Other More than 12 months since prior bisphosphonate therapy (oral or IV)
Sites / Locations
- Northwestern University
- Veterans Affairs Medical Center - Lakeside Chicago
- John H. Stroger Hospital of Cook County
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I
Arm II
Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity.
Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.