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：
7587990
负责人：
SUSAN L GREENSPAN
金额：
$ 73.45万
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/7587990
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 Data Dependence Diagnosis Dose Double-Blind Method Dropout Dual-Energy X-Ray Absorptiometry Effectiveness Elderly Elderly woman Endocrinology Enrollment FDA approved 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 Nursing Homes Oral Osteoporosis Osteoporosis prevention Outcome Outcome Measure Outcome Study Participant Patients Pharmaceutical Preparations Physicians Pilot Projects Population Postmenopause Prevention therapy Randomized Reporting Research Research Personnel Risedronate Risk Safety Self-Administered Spinal Fractures Staging Supplementation Surgeon Survival Rate Survivors Techniques Therapeutic Time Training Treatment Effectiveness Treatment Failure Universities Vertebral column Visit Vitamin D Woman Zoledronic Acid absorption age group base bisphosphonate bone bone health bone mass bone turnover cohort compliance behavior control trial design disability follow-up improved mortality neglect prevent prospective public health relevance randomized placebo controlled trial skeletal 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，髋关节或椎骨骨折的发生率是社区中的8-9倍。尽管有FDA批准的骨质疏松症疗法，但基于年轻妇女，最近的研究表明，口服双膦酸盐和髋垫在此脆弱的队列中无效。 IT治疗失败尚不知道是由于无效的药物，依从性差或非骨骼因素。在进行大型骨折研究之前，需要进行一项试点研究以检查安全性和功效。我们假设在脆弱的，制度化的老年妇女中，单剂量的静脉佐二酸酸将：1）有效，如维持或改善常规骨骼质量或减少骨骼周转的减少，2）安全且可行的，3）可用于计划未来的研究，以减少骨折的估算。为了解决这些假设，我们将在一项为期两年的钙 - 维生素D控制的，随机的，随机的双盲试验中，招募180名制度化的妇女，该试验是单剂量的静脉双膦酸盐二膦酸盐，唑吡甲酸。静脉治疗忽略了口服吸收或患者依从性较差的担忧。参与者将居住在与匹兹堡大学老年医学分工有关的长期护理环境中。结果指标将包括脊柱的骨密度和髋关节，骨转换的标记，椎骨X射线以评估裂缝和不良事件。匹兹堡地区的11个疗养院已同意参加。 PI是接受内分泌学和老年医学培训的少数医生之一，此前对骨质疏松症进行了疗养院研究。这项研究将提供有关骨质疏松症治疗的疗效和安全性的必要数据，这些妇女具有可行的单剂量单剂量的静脉抗吸收剂，并将为未来的多中心减少试验奠定基础。公共卫生相关性：骨质疏松症在疗养院居民中很常见，但大多数既未被诊断也没有治疗。这项研究将检查单剂量静脉治疗对骨质疏松症的有效性和安全性，在这个脆弱的组中，通常被忽略。