Opioid Use, Physical Function, Falls, and Fracture in Older Men

描述（由申请人提供）：老年人受肌肉骨骼疼痛疾病的影响不成比例，并且比年轻人接受更多的阿片类镇痛药，但阿片类药物治疗老年人持续性肌肉骨骼疼痛的益处和危害尚不清楚。本研究的目的是评估阿片类镇痛剂对患有持续性背部、髋关节或膝关节疼痛的老年男性的福尔斯、骨折和功能结局的潜在不良影响，并检查阿片类相关风险是否根据关键老年风险因素（即，基线功能损害、认知损害和身体机能差）。在一组患有持续性背部、臀部或膝盖疼痛的老年男性中，该研究旨在评价以下内容：1）阿片类镇痛剂使用与偶发和复发性福尔斯风险之间的相关性; 2）阿片类镇痛剂使用与偶发临床骨折风险之间的相关性; 3）阿片类镇痛剂使用与自我报告的身体功能和身体表现客观指标下降之间的相关性。本研究将分析NIH资助的65岁及以上社区居住男性前瞻性队列研究（男性骨质疏松性骨折（MrOS）研究）中收集的现有纵向数据。MrOS参与者在2000年至2002年期间完成了基线检查，并在大约4.5年和7年后完成了两次后续检查。从参与者每次检查时携带的药物容器中记录当前药物、剂量和使用频率。每次检查的评估包括客观身体表现（包括力量、动态平衡和步态速度）、自我报告的身体功能（包括日常生活和体力任务的独立活动限制）、认知功能和自我报告的身体活动。在两次访问之间，每四个月联系一次参与者，以确定新的福尔斯或骨折的发生。对于本研究，分析队列包括在基线时大部分或全部时间报告背部、髋关节或膝关节疼痛的MrOS参与者。将报告使用阿片类镇痛药的受试者与仅使用非阿片类镇痛药的受试者和报告未使用镇痛药的受试者进行比较。倾向评分将用于控制镇痛药使用组之间的基线差异。将使用广义估计方程对阿片类药物使用与事件福尔斯主要结局之间的关系进行建模（目的1）。作为次要指标，将使用logistic回归评价复发性福尔斯的结局。将使用生存分析检查阿片类药物使用与发生临床骨折之间的关联，以模拟首次骨折的时间（目的2）将老年风险因素及其与镇痛剂类别的相互作用作为额外协变量纳入后续模型中，以评价其对阿片类药物与福尔斯或骨折之间关联的影响。将使用逻辑回归对阿片类药物使用与a）身体功能和B）身体表现下降之间的关系进行建模（目的3）。

DESCRIPTION (provided by applicant): Older adults are disproportionately affected by musculoskeletal pain conditions and receive more opioid analgesics than younger persons, but benefits and harms of opioid therapy for persistent musculoskeletal pain in older adults are unclear. The objectives of this study are to evaluate potential adverse effects of opioid analgesics on falls, fractures, and functional outcomes in older men with persistent back, hip, or knee pain and to examine whether opioid-associated risk varies according to the presence of key geriatric risk factors (i.e., baseline functional impairment, cognitive impairment, and poor physical performance). In a cohort of older men with persistent back, hip, or knee pain, the study aims to evaluate the following: 1) associations between opioid analgesic use and risk of incident and recurrent falls; 2) associations between opioid analgesic use and risk of incident clinical fractures; and 3) associations between opioid analgesic use and decline in self-reported physical function and objective measures of physical performance. This study will analyze existing longitudinal data collected in an NIH-funded prospective cohort study of community-dwelling men age 65 years and older, the Osteoporotic Fractures in Men (MrOS) study. MrOS participants completed a baseline examination between 2000 and 2002 and two subsequent examinations, approximately 4.5 years and 7 years later. Current medications, dose, and frequency of use were recorded from medication containers that participants brought to each examination. Assessments at each examination included measures of objective physical performance (including strength, dynamic balance, and gait speed), self-reported physical function (including limitations in independent activities of daily living and physical tasks), cognitive function, and self-reported physical activity. Participants were contacted every four months between visits to determine occurrence of new falls or fractures. For this study, the analytic cohort includes MrOS participants who reported back, hip, or knee pain most or all of the time at baseline. Participants who reported opioid analgesic use will be compared with those who used only non-opioid analgesics and those who reported no analgesic use. Propensity scores will be used to control for baseline differences between analgesic use groups. Generalized estimating equations will be used to model the relationship between opioid use and the primary outcome of incident falls (aim 1). As a secondary measure, the outcome of recurrent falls will be evaluated using logistic regression. Associations between opioid use and incident clinical fractures will be examined using survival analysis to model time to first fracture (aim 2) Geriatric risk factors and their interactions with analgesic category will be included as additiona covariates in subsequent models to evaluate their effects on associations between opioids and falls or fractures. Logistic regression will be used to model the relationship between opioid use and decline in a) physical function and b) physical performance (aim 3).