PREVENTION OF BONE LOSS WITH ALENDRONATE IN PROSTATE CANCER WITH HORMONE DEPRIVA

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVE: Prostate cancer is the most frequently diagnosed neoplasm in men in the U.S. The standard treatment for Stage C and D prostate cancer is androgen deprivation therapy by either surgical orchiectomy or medically by gonadotropin releasing hormone (GnRH) agonist administration. A reduction in bone mineral density, resulting in osteoporosis and fractures, is an adverse effect associated with androgen deprivation therapy. The study is designed to prevent bone loss in men following medical androgen deprivation therapy. RESEARCH PLAN: Men with newly diagnosed prostate cancer who are scheduled to undergo treatment with a GnRH agonist will be randomized to receive alendronate or placebo. Alendronate is a drug known to prevent bone loss and fractures in postmenopausal women and recently has been shown to prevent bone loss in men. Bone mineral density measurement will be determined at baseline, 12 months and 24 months. Serum and urine markers of bone formation and resorption will be assayed at baseline and 6, 12 and 24 months. METHODS: Bone mineral density will be performed using dual energy x-ray absorptiometry. Markers of bone formation and resorption will be measured using immunoradiometric method (IRMA) and enzyme-linked immunoabsorbant assay. CLINICAL RELEVANCE: Increased osteoclastic bone resorption and bone loss, as a result of GnRH analog treatment in men with prostate carcinoma, may result in osteoporotic fractures. Preventing bone loss caused by GnRH analog therapy is the first step in preventing fractures and the morbidity and mortality associated with them. Future studies will determine the effect of preventing bone loss on fracture risk and bone metastasis in men with prostate cancer.