OSTEOPOROSIS TREATMENT IN THE NURSING HOME: NGRC TRIAL

疗养院骨质疏松症治疗：NGRC 试验

• 批准号: 6232365
• 负责人: William B. Ershler
• 金额: $ 7.98万
• 依托单位: INST/ADV STUDIES/AGING & GERIATRIC MED
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-30 至 2001-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6232365
• 关键词: behavioral /social science research tag; bone density; bone fracture; clinical research; clinical trials; comorbidity; diphosphonate; drug screening /evaluation; experimental designs; health care service planning; health services research tag; imidazole; informed consent; nursing homes; osteoporosis; patient care planning; quality of life; skeletal disorder chemotherapy

DESCRIPTION (Taken from the application): Osteoporosis is a major cause of morbidity and mortality in the United States. It is a disease of aging and its prevalence increases with each decade of life. In the typical nursing home, well over half of the residents will have remarkably diminished bone density and most of these individuals are susceptible to fractures. Optimal therapy has not been established. The current proposal is a clinical trial planning grant. Fourteen medical school affiliated nursing homes have organized into a research cooperative (The National Geriatrics Research Consortium [NGRC]) for the purpose of strengthening clinical research in the nursing home. This consortium plans to investigate a newly developed pharmacologic agent, zoledronate, for the treatment of osteoporosis in nursing home patients. In a one year planning phase, issues of research methodology and clinical trial design will be examined and a coordinated research proposal will be submitted upon completion of this planning phase. Several features about nursing home research make such a planning period advantageous. These include the likelihood of coexisting medical conditions in the patient volunteers and the frequent use of multiple other prescription medications. Furthermore, issues of informed consent from patients with cognitive impairment (as is the case with many, if not most of the potential subjects in our proposed trial), need to be fully understood. Details of the proposed trial are under development but it is the current expectation that it will be a multi institutional (NGRC), masked, randomized, placebo controlled clinical study in which nursing home patients with osteoporosis will receive either zoledronate or placebo every two months for two years. The primary outcome to be measured will be the occurrence of fractures and secondary outcomes will be pain relief, quality of life and bone mineral density. The outcome of this planning grant will be well constructed research proposal describing in detail this proposed clinical research.

描述(取自申请表)： 骨质疏松症是美国发病率和死亡率的主要原因。 它是一种老年病，其患病率每十年就会增加一次。 在典型的疗养院，超过一半的居民将拥有 骨密度显著降低，这些人中的大多数都是 易骨折的易骨折的最佳的治疗方法尚未确定。海流 提案是一项临床试验计划拨款。14所附属医学院 养老院组成了一个研究合作社(国家 老年医学研究联盟[NGRC])以加强 疗养院的临床研究。该财团计划调查一起 新开发的药理学药物唑来膦酸盐，用于治疗糖尿病 养老院患者的骨质疏松症。在为期一年的规划阶段， 将审查研究方法和临床试验设计，并 协调研究方案将在完成后提交 规划阶段。养老院研究的几个特点使这样的 规划期有利。这些因素包括共存的可能性 在患者自愿的医疗条件下和频繁使用多药 其他处方药。此外，知情同意的问题来自 有认知障碍的患者(许多患者，如果不是大多数的话 我们提议的试验中的潜在受试者)，需要完全理解。 拟议试验的细节正在制定中，但这是目前的 期望它将是一个多机构(NGRC)，蒙面，随机， 安慰剂对照临床研究中，疗养院患者 骨质疏松症将每两个月接受一次唑来膦酸盐或安慰剂治疗 两年了。要衡量的主要结果将是发生 骨折和次要结果将是疼痛缓解、生活质量和骨骼 矿物质密度。这笔规划赠款的成果将得到很好的构建 详细描述这项拟议的临床研究的研究建议书。