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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。目的：前列腺癌是美国男性中最常见的肿瘤，C期和D期前列腺癌的标准治疗是雄激素剥夺治疗，要么通过手术切除睾丸，要么通过药物治疗促性腺激素释放激素（GnRH）激动剂。骨密度降低，导致骨质疏松和骨折，是与雄激素剥夺治疗相关的不良反应。这项研究旨在防止男性在接受雄激素剥夺治疗后骨质流失。研究计划：计划接受GnRH激动剂治疗的新诊断前列腺癌患者将随机接受阿仑膦酸钠或安慰剂治疗。阿仑膦酸钠是一种预防绝经后妇女骨质流失和骨折的药物，最近也被证明可以预防男性骨质流失。骨密度测量将在基线、12个月和24个月时测定。在基线和6、12和24个月时检测血清和尿液中骨形成和吸收的标志物。方法：采用双能x线骨密度仪测定骨密度。骨形成和骨吸收的标志物将使用免疫放射测定法（IRMA）和酶联免疫吸收测定法进行测量。临床相关性：前列腺癌患者接受GnRH类似物治疗后，破骨细胞骨吸收和骨质流失增加，可能导致骨质疏松性骨折。预防GnRH模拟疗法引起的骨质流失是预防骨折及其相关发病率和死亡率的第一步。未来的研究将确定预防骨质流失对前列腺癌患者骨折风险和骨转移的影响。

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.