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

阿仑膦酸钠在激素剥夺治疗中预防前列腺癌中的骨丢失

• 批准号: 7378152
• 负责人: JAN M BRUDER
• 金额: $ 0.04万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378152
• 关键词: PREVENTION; BONE; LOSS; ALENDRONATE; PROSTATE

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。目的：前列腺癌是美国男性最常诊断的肿瘤，C阶段C和D期前列腺癌的标准治疗方法是通过外科手术甲切除术或医学上通过促性腺激素释放激素（GNRH）激动剂治疗的雄激素剥夺治疗。骨矿物质密度的降低，导致骨质疏松症和骨折，是与雄激素剥夺治疗相关的不良影响。该研究旨在防止医学雄激素剥夺治疗后男性骨质流失。 研究计划：新诊断为前列腺癌的男性计划接受GNRH激动剂进行治疗的男性，将随机接受alendronrate或安慰剂。 alendronate是一种已知的药物，可预防绝经后妇女的骨质流失和骨折，最近已被证明可以预防男性骨质流失。骨矿物质密度测量将在基线，12个月零24个月时确定。骨形成和吸收的血清和尿液标志物将在基线和6、12和24个月进行测定。 方法：将使用双能X射线吸收法进行骨矿物质密度。骨形成和吸收的标志物将使用免疫放射测量法（IRMA）和酶联免疫动作测定法测量。 临床相关性：由于前列腺癌男性的GNRH模拟治疗，破骨碎裂的骨吸收和骨质流失可能导致骨质疏松性骨折。防止GNRH模拟疗法引起的骨质流失是预防骨折以及与之相关的发病率和死亡率的第一步。未来的研究将确定预防前列腺癌男性骨折风险和骨转移的影响。