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Maintenance of Skeletal Integrity in Frail Elders

维持体弱老年人骨骼的完整性

基本信息

批准号：
7678235
负责人：
SUSAN L GREENSPAN
金额：
$ 1.67万
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：
2007
资助国家：
美国
起止时间：
2007-03-15 至 2012-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7678235
关键词：
Acids Address Adverse event Age Age-Years Alendronate Area Attention Benefits and Risks Biochemical Markers Biological Bone Density Bone Resorption Calcium Caring Cessation of life Clinical Clinical Research Communities Condition Daily Data Dependence Diagnosis Dose Double-Blind Method Dropout Dual-Energy X-Ray Absorptiometry Effectiveness Elderly Elderly woman End Point Endocrinology Enrollment Family member Foundations Fracture Frail Elderly Future Geriatrics Hip Fractures Hip region structure Hospitalization Impaired cognition Incidence Individual Institution Interview Intravenous Investigation Joints Laboratories Life Long-Term Care Maintenance Malignant Neoplasms Measurement Measures Medical Medical Dictionaries Myalgia NIH Consensus Development Conferences Numbers Nursing Homes Oral Osteoporosis Osteoporosis prevention Outcome Outcome Measure Outcome Study Participant Patients Pharmaceutical Preparations Physicians Pilot Projects Population Postmenopause Prevention therapy Public Health Randomized Rate Reporting Research Research Personnel Risedronate Risk Safety Self-Administered Skeletal system Spinal Fractures Staging Standards of Weights and Measures Supplementation Surgeon Survival Rate Survivors Techniques Therapeutic Time Training Treatment Effectiveness Treatment Failure United States Food and Drug Administration Universities Vertebral column Visit Vitamin D Woman Zoledronic Acid absorption age group aged base bisphosphonate bone bone health bone turnover cohort compliance behavior design disability follow-up improved mortality neglect prevent prospective randomized placebo controlled trial spine bone structure

项目摘要

DESCRIPTION (provided by applicant): Approximately 80% of residents in long term care institutions have osteoporosis and the incidence of hip or vertebral fractures is 8-9 times that in the community. Although there are FDA approved therapies for osteoporosis, based on younger women, recent studies demonstrate that oral bisphosphonates and hip pads are not effective in this frail cohort. It is not known it treatment failures are due to ineffective medication, poor compliance, or nonskeletal factors. Prior to a large fracture reduction study, a pilot study is critically needed to examine safety and efficacy. We postulate that in frail, institutionalized elderly women, a single dose of intravenous zoledronic acid will: 1) be efficacious as demonstrated by maintenance or improvements in conventional bone mass and reductions in bone turnover, 2) be safe and feasible, 3) provide estimates for fracture reduction in this cohort for use in planning a future study. To address these hypotheses, we will enroll 180 institutionalized women in a 2-year, calcium-vitamin D controlled, randomized, double-blind trial of a single dose of intravenous bisphosphonate, zoledronic acid. The intravenous therapy omits concerns regarding poor oral absorption or patient compliance. Participants will reside in the long term care settings associated with the Division of Geriatric Medicine, University of Pittsburgh. Outcome measures will include bone density of the spine and hip, markers of bone turnover, vertebral x rays to assess for fractures and adverse events. Eleven nursing homes in the Pittsburgh area have agreed to participate. The PI is one of a handful of physicians trained in endocrinology and geriatric medicine, who previously conducted nursing home research on osteoporosis. This study will provide the necessary data on the efficacy and safety of osteoporosis treatment in elderly women with a feasible single dose of intravenous antiresorptive agent, and will lay the foundation for a future multicenter fracture reduction trial in this cohort. Public Health Relevance: Osteoporosis is common in nursing home residents, yet most are neither diagnosed nor treated. This study will examine the effectiveness and safety of a single dose intravenous therapy for osteoporosis in this frail, often neglected group.

描述（由申请人提供）：长期护理机构中约80%的居民患有骨质疏松症，髋部或椎骨骨折的发病率是社区的8-9倍。虽然有FDA批准的治疗骨质疏松症的方法，基于年轻女性，最近的研究表明，口服双膦酸盐和髋关节垫是无效的，在这个脆弱的队列。目前尚不清楚治疗失败是由于药物无效，依从性差，或非骨骼因素。在进行大型骨折复位研究之前，迫切需要进行一项初步研究来检查安全性和有效性。我们假设，在体弱、住院的老年女性中，单剂量静脉注射唑来膦酸将：1）有效，如常规骨量的维持或改善以及骨转换的减少所证明的，2）安全可行，3）提供该队列中骨折减少的估计值，用于规划未来的研究。为了解决这些假设，我们将招募180名住院妇女参加一项为期2年的、钙-维生素D对照、随机、双盲试验，单剂量静脉注射双膦酸盐、唑来膦酸。静脉内治疗忽略了口服吸收不良或患者依从性差的问题。参与者将居住在与匹兹堡大学老年医学部相关的长期护理机构。结果测量将包括脊柱和髋关节的骨密度、骨转换标志物、评估骨折和不良事件的椎骨X线片。匹兹堡地区的11家养老院已同意参加。PI是少数接受过内分泌学和老年医学培训的医生之一，他们以前曾对骨质疏松症进行过疗养院研究。本研究将为单剂量静脉注射抗骨吸收药物治疗老年女性骨质疏松症的有效性和安全性提供必要的数据，并为今后在该队列中开展多中心骨折复位试验奠定基础。公共卫生相关性：骨质疏松症在养老院居民中很常见，但大多数既没有诊断也没有治疗。本研究将检查单剂量静脉注射治疗骨质疏松症的有效性和安全性，在这个脆弱的，往往被忽视的群体。