PHARMACOLOGIC/NON-PHARMACOLOGIC TREATMENT OF OSTEOPOROSIS

骨质疏松症的药物/非药物治疗

• 批准号: 3726692
• 负责人: WILLIAM APPLEGATE
• 金额: --
• 依托单位: WAKE FOREST UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3726692
• 关键词: accidental falls; aerobic exercise; aging; balance; biopsy; blood chemistry; bone density; calcitonin; clinical trials; dietary calcium; disease /disorder proneness /risk; frail elderly; health care cost /financing; hip; hip fractures; hormone therapy; human old age (65+); human subject; human therapy evaluation; human very old age (85+); injection /infusion; longitudinal human study; nutrition related tag; osteoporosis; photon absorptiometry; quality of life; questionnaires; skeletal disorder chemotherapy; therapy compliance; urinalysis; vitamin D; vitamin therapy

As stated by a recent consensus conference sponsored by the National Institute of Arthritis and Musculoskeletal, Skin Diseases, osteoporosis is a major cause of mortality, morbidity, and disability world wide. It is our hypothesis that the combination of the pharmacologic plus a non- pharmacologic intervention in elderly persons with low bone mineral density (BMD) and a high risk of falls will have a synergistic effect in increasing bone mineral density over time. It is also our hypothesis that since low BMD is a necessary but not sufficient cause for hip fractures a non- pharmacologic intervention targeted towards persons at risk for fall will improve their endurance gait and balance and decrease their risk for future falls as well as increase their BMD. This proposal is presented as an intervention development study because we did not have sufficient preliminary data on the effects of the non-pharmacologic intervention and we need to test the feasibility of recruitment and acceptance of a non- pharmacologic treatment which will require nasal inhalation and if that is not tolerated, self injections. Tests of feasibility of this two center randomized trial we will enroll 10 participants per center (total 80) in each of 4 arms: 1) pharmacologic (calcitonin plus Vitamin D), 2) non- pharmacologic (exercise), 3) combination pharmacologic and non- pharmacologic, and 4) control. Therefore our specific aims of the feasibility study are to assess the feasibility, acceptability, tolerance, and compliance for the pharmacologic intervention, to assess the feasibility of recruitment, enrollment, and adherence, and to pilot test the various measures proposed including obtaining and calculating costs of the interventions. Based on the feasibility study, we will conduct a full trial to reduce falls and fractures in people at high risk for hip fracture.

正如国民国家最近发起的共识会议所述 关节炎和肌肉骨骼，皮肤疾病，骨质疏松症是 全球死亡率，发病率和残疾的主要原因。 这是 我们的假设是药理学和非 - 骨矿物质密度低的老年人的药理干预 （BMD）和跌倒的高风险将对增加产生协同作用 随着时间的流逝，骨矿物质密度。 我们的假设也是我们的假设 BMD是髋部骨折的必要原因但不是足够的原因 针对有秋季风险的人的药理干预将 改善他们的耐力步态和平衡，并降低未来的风险 跌倒并增加其BMD。 该提议作为一个 干预开发研究是因为我们没有足够的 关于非药物干预效果的初步数据 我们需要测试招聘和接受非 - 需要鼻吸入的药理治疗，如果是 不容忍自我注射。 这两个中心的可行性测试 随机试验我们将在每个中心注册10名参与者（总计80） 四个臂中的每一个：1）药理学（降钙素加维生素D），2）非 - 药理学（练习），3）药理学和非 - 药理学和4）控制。 因此，我们的具体目标 可行性研究是为了评估可行性，可接受性，容忍度， 和药理学干预的合规性，以评估 招聘，入学和遵守的可行性以及对试点测试的可行性 提出的各种措施，包括获得和计算成本 干预措施。 根据可行性研究，我们将进行完整的 试验以减少臀部高风险的人的跌倒和骨折 断裂。