Sustaining Skeletal Health in Frail Elderly

维持体弱老年人的骨骼健康

基本信息

批准号：
9904388
负责人：
SUSAN L GREENSPAN
金额：
$ 92.07万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-04-01 至 2022-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9904388
关键词：
3-Dimensional Acute-Phase Reaction Address Adverse event Age Aging Area Benefits and Risks Bone Density Bone structure Calcium Characteristics Clinical Treatment Clinical Trials Cognitive Communities Consensus Consumption Data Dependence Disease Double-Blind Method Effectiveness Elderly Enrollment Face Foundations Fracture Frail Elderly Future Gait speed Goals Health Health care facility Hip Fractures Hip region structure Hospitalization Hypocalcemia result Image Impaired cognition Impairment Incidence Infection Infrastructure International Investigation Kidney Failure Long-Term Care Malnutrition Masks Measurement Measures Monitor Notification Oral Osteoporosis Outcome Patients Personal Satisfaction Pharmaceutical Preparations Population Postmenopause Public Health Quality of life Randomized Regression Analysis Resources Risk Safety Serious Adverse Event Site Spinal Fractures System TRANCE protein Techniques Testing Time Trabecular Bone Score United States National Institutes of Health Vertebral column Vitamin D Vitamin D Deficiency Vulnerable Populations Woman Zoledronic Acid absorption bisphosphonate bone health bone turnover cohort comorbidity cost data mining efficacy testing falls fracture risk functional disability functional status health knowledge high risk human old age (65+)improved inhibitor/antagonist innovation men mortality neglect novel osteoporosis with pathological fracture point of care predicting response preservation public health relevance responders and non-responders sedentary side effect skeletal spine bone structure subcutaneous targeted treatment

项目摘要

DESCRIPTION (provided by applicant): Although close to 85% of residents in long-term care facilities (LTC) have osteoporosis and the risk of osteoporotic fractures is nearly 10 times that o community dwelling elderly, few are treated and studies are scarce. The large pivotal osteoporosis trials in postmenopausal women exclude those who are sedentary, frail or functionally impaired even though this is the group at highest risk. The potentially potent therapies for osteoporosis in the young may have more risks than benefits in fragile elderly. Furthermore, there are limited data in men. Even though fracture reduction studies are desperately needed, these trials are large, long, and resource intense. Before a fracture reduction study can be justified in this cohort, an investigation demonstrating efficacy and predictability is a necessary first step. We will test the hypotheses that in frail institutionalizd men and women, semiannual subcutaneous denosumab will 1) be efficacious as demonstrated by improvements or preservation in conventional bone density measurements, 2) improve novel measures of trabecular microstructure, and 3) allow us to characterize likely responders. To address these hypotheses, we propose to conduct a 2-year, randomized, double-blind, calcium-vitamin D controlled trial to test the efficacy and predictability of response of the antiresorptiv RANK ligand inhibitor, denosumab, among a cohort of 200 institutionalized frail (gait speed <0.8 m/sec) men and women ≥ 65 years old. This semiannual subcutaneous therapy negates concerns regarding poor oral absorption or compliance. Use of a non-bisphosphonate avoids the IV-associated acute phase reaction or renal insufficiency contraindications common in this cohort. Assessments will be performed in a mobile lab and will include conventional bone density of the spine and hip, trabecular bone score, markers of bone turnover, fractures, functional status, mobility and safety. Innovative features include 1) the neglected LTC population, 2) inclusion of men, 3) assessment of trabecular microstructure, 4) point of care vertebral fracture images, 5) mobile lab for onsite, state-of-the-art assessments and 6) an electronic alert system to collect real time serious adverse events including potential denosumab associated adverse events of infection or hypocalcemia. Eight LTC facilities in the Pittsburgh area have agreed to participate. We have the unique advantage of building on our established LTC infrastructure and track record. Regardless of outcome, critical public health knowledge will be gained. This study will provide the necessary data on the efficacy and predictability of response to osteoporosis treatment in LTC residents and will lay the foundation for future effectiveness studies.

描述（由适用提供）：尽管长期护理设施中近85％的居民（LTC）患有骨质疏松症，骨质疏松性骨折的风险几乎是O型社区居住的10倍，但很少有治疗和研究很少。绝经后妇女的大型关键骨质疏松试验不包括那些久坐，脆弱或功能障碍的人，即使这是处于最高风险的群体。年轻人中骨质疏松症的潜在潜在疗法可能比脆弱的老年人具有更多的风险。此外，男性的数据有限。即使迫切需要减少碎片的研究，这些试验还是大型，长期且资源密集的。在该队列中可以证明片段还原研究是合理的之前，一项研究表明效率和可预测性是必要的第一步。我们将检验以下假设：在脆弱的男性和女性中，半年度皮下denosumab 1）有效地表明，通过改进或制备常规骨密度测量值，2）改善小径微观结构的新颖测量以及3）允许我们表征可能的受访者。为了解决这些假设，我们建议进行2年，随机，双盲，钙 - 维生素D对照试验，以测试抗吸烟级配体抑制剂denosumab的有效性和可预测性，在200个制度化的脆弱速度（Gait Speed <0.8 m/sec）的男性和女性女性和女性25岁的同类群中。这种半年度皮下治疗否定了口服吸收或依从性差的关注。使用非双膦酸盐避免了与该队列中常见的IV相关急性相反应或肾功能不全的禁忌症。评估将在移动实验室中进行，其中包括脊柱和臀部的常规骨密度，小梁骨评分，骨转换的标记，断裂，功能状态，迁移率和安全性。创新特征包括1）负LTC人群，2）包含男性，3）小梁微观结构的评估，4）护理点椎骨骨折图像，5）用于现场的移动实验室，最先进的评估，6）电子警报系统，用于收集潜在的denosumab的不良不良事件，包括与潜在的不良事件相关的感染或hypsypersypercectia hyphypervey Infection或Infection hypervection hypervection或hypection hypercection coccalcalia。匹兹堡地区的八个LTC设施已同意参加。我们具有建立我们已建立的LTC基础架构和往绩记录的独特优势。无论结果如何，都将获得关键的公共卫生知识。这项研究将提供有关LTC居民对骨质疏松治疗反应的有效性和可预测性的必要数据，并将为未来的有效性研究奠定基础。