Low Magnitude Mechanical Stimulation to Improve BMD

7.项目摘要/摘要 老年人骨折的预防主要集中在抑制骨折的药物干预 骨吸收。需要非药物方法来改善肌肉骨骼系统作为一种 整体并最终降低骨折的风险，构成了我们正在进行的这一竞争延续的基础 低幅度机械刺激(LMMS)的随机、双盲、安慰剂对照试验 “共鸣”审判。这项试验于2007年启动，目的是研究LMM对骨骼的影响，该试验随机选择了174名 最初以200名老年参与者为目标，遵从率为80%。在这个续篇中，我们建议 将研究干预和随访延长一年，并通过以下方式扩大科学范围 考虑到与肌肉骨骼健康有关的更广泛的衡量标准，包括肌肉面积、密度、 力量，以及姿势的稳定性。这也将增加我们对初级骨骼结果的能力， 如果试验不再继续一年，这一比例将仅为41%。用于试验的dsmb具有 建议不要使当前研究的任何方面失明，并支持扩大共鸣 审判。这项临床试验的主要假设是，LMM将对骨骼、肌肉、 以及独立生活的老年人的姿势稳定性。因此，该项目的第一个目标是 通过评估系列定量计算确定LMM在三年期间的骨骼效应 成人髋部和脊柱骨密度的体层摄影术测量 老年受试者已经参加了最初为期两年的研究。在试验期间，我们开发了小说 检查我们的髋部QCT扫描肌肉面积和密度的方法，并一直在收集其他 最初没有包括在试验中的测量，即腿部肌肉力量和姿势 使用平衡平台的稳定性。这提供了第二个目标所基于的数据。我们假设 LMM将导致肌肉面积、密度和力量的改善，并将改善平衡。正在进行的 试验在老年社区中建立得很好，研究小组有成功的记录，在那里 到目前为止还没有安全方面的担忧。因此，现在有一个机会之窗，可以继续审判 额外的一年，并测试围绕这一独特的非药物干预的多个假设。

7. PROJECT SUMMARY/ABSTRACT The prevention of fractures in the aged population is largely focused on pharmacologic interventions that inhibit bone resorption. The need for non-pharmacologic approaches to improve the musculoskeletal system as a whole and ultimately reduce the risk for fracture, forms the basis for this competing continuation of our ongoing randomized, double-blind, placebo-controlled trial of low magnitude mechanical stimulation (LMMS) called the "VIBES" trial. This trial, initiated in 2007 to study the skeletal effects of LMMS, has randomized 174 of the originally targeted 200 elderly participants with an adherence rate of 80%. In this continuation, we propose to extend the study intervention and follow up by one additional year, and to expand the scope of the science by considering a broader range of measures relevant to musculoskeletal health, including muscle area, density, and strength, as well as postural stability. This will also increase our power for the primary skeletal outcomes, which will be only 41% if the trial does not continue one additional year. The DSMB for the trial has recommended not unblinding any aspect of the current study, and is supportive of the extension to the VIBES trial. The overarching hypothesis of this clinical trial is that LMMS will have favorable effects on bone, muscle, and postural stability in a sample of independently living seniors. Thus the first aim of the project is to determine the skeletal effects of LMMS over a three year period by assessing serial quantitative computed tomography (QCT) measures of volumetric trabecular bone mineral density (vTBMB) of the hip and spine in the elderly subjects already enrolled in the original two-year study. During the trial we have developed novel methods of examining our QCT scans of the hip for muscle area and density, and have been collecting other measures not originally included in the trial, namely, muscle strength of the lower extremity, and postural stability using a balance platform. This provides data upon which the second aim is based. We hypothesize that LMMS will result in improved muscle area, density and strength, and will improve balance. The ongoing trial is well established in the senior communities, the study team has a successful track record, and there have been no safety concerns to date. Thus there is now a window of opportunity to continue the trial for an additional year and test multiple hypotheses surrounding this unique non-pharmacologic intervention.