COMBINING TESTOSTERONE THERAPY AND EXERCISE TO IMPROVE FUNCTION POST HIP FRACTURE

结合睾酮治疗和锻炼来改善髋部骨折后的功能

• 批准号: 8444997
• 负责人: ELLEN F BINDER
• 金额: $ 18.15万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8444997
• 关键词: Activities of Daily Living; Address; Age; Agreement; Androgens; Applications Grants; Certification; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Communities; Computer software; Conduct Clinical Trials; Data Analyses; Data Collection; Data Quality; Elderly; Elderly woman; Eligibility Determination; Ensure; Event; Exclusion Criteria; Exercise; Experimental Designs; Feasibility Studies; Female; Fracture; Frail Elderly; Gender; Goals; Health Care Costs; Hip Fractures; Imaging Techniques; Independent Living; Individual; Injury; Institutionalization; Intervention; Laboratories; Lead; Life; Magnetic Resonance Imaging; Manuals; Measurement; Methods; Monitor; Multi-Institutional Clinical Trial; National Institute on Aging; Operative Surgical Procedures; Outcome Study; Patients; Performance; Pharmaceutical Preparations; Pharmacy facility; Physical Function; Physical therapy exercises; Pilot Projects; Placebos; Population; Procedures; Protocols documentation; Public Health; Quality Control; Randomized; Randomized Clinical Trials; Recovery; Recurrence; Research; Research Personnel; Resources; Role; Safety; Sample Size; Services; Site; Skeletal Muscle; Specific qualifier value; Standardization; System; Testing; Testosterone; Training; Translating; Treatment outcome; aged; clinical research site; data integrity; data management; double-blind placebo controlled trial; falls; frailty; functional decline; high risk; improved; improved functioning; meetings; member; muscle form; muscle strength; older women; patient population; prospective; public health relevance; repaired; response; sarcopenia; testosterone replacement therapy; tool development

DESCRIPTION (provided by applicant): Hip fractures are common in elderly women and can have a devastating impact on their ability to remain independent. A significant functional decline following a hip fracture has been documented, and many patients have persistent strength and mobility deficits that impair their capacity for independent living. Such individuals are at high rsk for continued supportive services, recurrent injury, and institutionalization. High-risk patients include those with deficits in skeletal muscle strength during the post-fracture period. Age-associated androgen deficiency contributes to deficits in muscle mass and strength that are common in this patient population. Exercise training can reverse deficits in skeletal muscle strength and functional performance to a modest degree. We have observed a high rate of testosterone deficiency in elderly female hip fracture patients with physical frailty. The role of testosterone therapy for improving deficits in muscle mass, strength, and functional capacity in the frail elderly is unclear, particularly for elderly women. Expanding from our R21 project which showed study feasibility, the proposed project will develop a prospective randomized, double-blinded, placebo-controlled trial to determine, in community-dwelling elderly (e65 yrs) female hip fracture patients, the efficacy of 6 months of testosterone therapy and exercise training, alone and in combination, at improving muscle strength and physical function after the fracture event. Our specific aims are to: 1) Finalize the protocol for the proposed clinical trial (study hypothese and experimental design, eligibility criteria, details of study treatments, safety assessments, sample size, analysis plan, including plans for an interim analysis); 2) Establish the research team and finalize the collaborative arrangements for the trial (clinical trial sites and related agreements); 3) Develop a plan for data management and quality control; 4) Develop a detailed manual of procedures including establishing the means to assure standardization of procedures across sites, and plans for staff training and certification. We will bring together an outstandin team of investigators with expertise conducting clinical trials of hip fracture patients, testosterone replacement therapy, exercise training, clinical trial design, MRI and Quantitative CT imaging techniques, data analysis and management. These efforts will lead to submission of a grant application to the National Institute on Aging (NIA) to test the role for the proposed interventions in elderly female hip fracture patients. The proposed clinical trial will also be the first to elucidate the role of testosterone therapy combined with exercise training for improving recovery in elderly women after hip fracture, which is a problem with a large public health impact.

描述（由申请人提供）：髋部骨折在老年妇女中很常见，可能对她们保持独立的能力产生破坏性影响。髋部骨折后的功能明显下降，许多患者有持续的力量和活动能力不足，损害了他们独立生活的能力。这些人是在高风险的持续支持服务，经常性伤害，和机构。高风险患者包括骨折后骨骼肌力量不足的患者。雄激素相关的雄激素缺乏导致肌肉质量和力量不足，这在该患者人群中很常见。运动训练可以在一定程度上逆转骨骼肌力量和功能表现的缺陷。我们观察到老年女性髋部骨折患者中睾酮缺乏的比例很高，身体虚弱。睾酮治疗对改善虚弱老年人肌肉质量、力量和功能能力不足的作用尚不清楚，特别是对老年妇女。 从我们的R21项目扩展， 研究的可行性，拟议的项目将开发一个前瞻性随机，双盲，安慰剂对照试验，以确定，在社区居住的老年女性髋部骨折患者，6个月的睾酮治疗和运动训练，单独和组合，在骨折事件后改善肌肉力量和身体功能的疗效。我们的具体目标是：1）完成拟议临床试验的方案（研究假设和实验设计、合格标准、研究治疗细节、安全性评估、样本量、分析计划，包括中期分析计划）; 2）建立研究团队，并最终确定试验的合作安排（临床试验中心和相关协议）; 3）制定数据管理和质量控制计划; 4）制定详细的程序手册，包括确定确保各地点程序标准化的方法，以及员工培训和认证计划。 我们将汇集一支优秀的研究团队，他们具有进行髋部骨折患者临床试验、睾酮替代疗法、运动训练、临床试验设计、MRI和定量CT成像技术、数据分析和管理的专业知识。这些努力将导致向国家老龄化研究所（NIA）提交赠款申请，以测试拟议干预措施在老年女性髋部骨折患者中的作用。拟议的临床试验也将是 首次阐明睾酮治疗结合运动训练在改善老年女性髋部骨折后恢复方面的作用，髋部骨折是一个对公共卫生影响很大的问题。