Determinants of Recovery Following Hip Fracture

髋部骨折是一个重大的公共卫生问题。 我们以前的研究结果表明，在髋部骨折后的一年中，股骨颈骨矿物质密度（BMD）下降了4.6%; BMD的这种急剧下降伴随着骨代谢标志物的显著变化。 拟议的辅助研究的父项目是一项随机对照试验，旨在最大限度地减少髋部骨折后BMD、肌肉和功能的损失。 拟议的辅助研究将评估参与本干预研究的髋部骨折患者的骨代谢标志物和选定的调节激素，以更好地了解髋部骨折后一年内运动影响骨骼健康的机制。 这些标志物和激素也将在一年的时间内在一组匹配的非骨折对照中进行评估，以确定骨代谢标志物在一组同样具有低BMD的虚弱老年人中的预期水平和变化。拟议研究的主要目的是：1）通过比较随机接受家庭运动干预的患者与接受常规护理的患者在髋部骨折后一年内的骨代谢，评估运动对髋部骨折后骨代谢的作用，和2）通过比较髋部骨折后骨代谢的变化，将髋部骨折对骨代谢的影响与年龄对类似低BMD人群骨代谢的影响分开在非骨折对照组中接受骨代谢常规治疗的患者。这些问题将使用来自170例年龄65岁以上的女性髋部骨折患者（100例入组母研究，另外70例髋部骨折患者将被招募用于本辅助研究）和85例年龄和活动度匹配的BMD小于0.82 g/cm 2的非骨折对照的数据来解决。 患者被随机分配到一个为期一年的，以家庭为基础的锻炼计划，开始时，急性后治疗结束，或常规护理。 作为母研究的一部分，100名患者在住院期间以及2个月、6个月和12个月时测量BMD，并采集、处理和储存这100名患者的血液样本。 对于辅助研究，该方案将扩展至包括70例额外的髋部骨折患者和85例非骨折对照，后者将在入组时和12个月后进行测量。 对于该辅助研究，所有血液样本（即，在母研究中从100名患者身上收集的数据和在辅助研究中从70名患者和85名非骨折对照身上收集的数据）将被分析以确定四种骨代谢标志物和三种调节激素的水平。 这种类型的信息将有助于制定干预措施，以改善骨骼健康和最大限度地恢复。

Hip fracture is a major public health problem. Results from our previous work demonstrate a 4.6 percent loss of femoral neck bone mineral density (BMD) during the year following a hip fracture; this dramatic loss in BMD is accompanied by notable changes in markers of bone metabolism. The parent project to the proposed ancillary study is a randomized controlled trial of a home-based exercise program intended to minimize losses in BMD, muscle and function following a hip fracture. The proposed ancillary study will evaluate markers of bone metabolism and selected regulating hormones in hip fracture patients who are participating in this intervention study in order to gain a better understanding of the mechanism by which exercise affects bone health during the year following a hip fracture. These markers and hormones also will be evaluated over a one year period in a matched group of non-fracture controls to establish expected levels and changes in markers of bone metabolism among a frail group of older persons who also have low BMD. The primary aims of the proposed study are: 1) to evaluate the role of exercise on bone metabolism following hip fracture by comparing bone metabolism during the year after hip fracture in patients randomized to a home-based exercise intervention with patients assigned to usual care, and 2) to separate the effects of hip fracture on bone metabolism from those of aging in similar persons with low BMD by comparing bone metabolism in hip fracture patients receiving usual care with bone metabolism in a matched group of non-fracture controls. These issues will be addressed using data from 170 female hip fracture patients age 65 plus (100 enrolled in the parent study, and an additional 70 hip fracture patients to be recruited for this ancillary study), and 85 age- and mobility-matched non- fracture controls with BMD Less than 0.82g/cm2. Patients are randomized to a year-long, home-based exercise program to begin when post-acute therapy ends, or usual care. As part of the parent study, 100 patients are having BMD measured during their hospital stay, and again at 2, 6, and 12 months, and blood samples for these 100 patients are being taken, processed, and stored. For the ancillary study, this protocol will be extended to include 70 additional hip fracture patients and 85 non- fracture controls, the latter of which will be measured at point of enrollment and 12 months later. For this ancillary study, all blood samples (i.e., those collected on 100 patients in the parent study and those collected on 70 patients and 85 non- fracture controls in the ancillary study) will be assayed to determine levels of four markers of bone metabolism and three regulating hormones. Information of this type will be useful developing interventions to improve bone health and maximize recovery.