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.

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。目的：前列腺癌是美国男性最常见的肿瘤。C、D期前列腺癌的标准治疗方法是通过手术切除或内科应用促性腺激素释放激素(GnRH)激动剂来去除雄激素。骨质密度降低，导致骨质疏松症和骨折，这是雄激素剥夺疗法的副作用。这项研究旨在预防男性在接受内科雄激素剥夺治疗后的骨质流失。研究计划：计划接受促性腺激素释放激素激动剂治疗的新诊断前列腺癌患者将随机接受阿仑膦酸盐或安慰剂治疗。阿伦磷酸钠是一种已知的预防绝经后妇女骨丢失和骨折的药物，最近被证明可以预防男性的骨丢失。骨密度测量将在基线、12个月和24个月进行。在基线、6个月、12个月和24个月时检测血清和尿骨形成和骨吸收标志物。方法：采用双能X线骨密度仪进行骨密度测量。骨形成和骨吸收的标记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。临床意义：前列腺癌患者接受促性腺激素释放激素类似物治疗后，破骨细胞性骨吸收和骨丢失增加，可能导致骨质疏松性骨折。预防GnRH类似疗法引起的骨丢失是预防骨折及其相关的发病率和死亡率的第一步。未来的研究将确定预防骨丢失对前列腺癌男性骨折风险和骨转移的影响。