Low Magnitude Mechanical Stimulation to Improve BMD

7.项目总结/摘要 老年人群骨折的预防主要集中在药物干预， 骨吸收需要非药物方法来改善肌肉骨骼系统， 整体，并最终降低骨折的风险，构成了我们持续竞争的基础。 一项随机、双盲、安慰剂对照的低强度机械刺激（LMMS）试验，称为 “VIBES”审判。这项试验于2007年开始，研究LMMS对骨骼的影响，随机抽取了174名受试者， 最初的目标是200名老年参与者，依从率为80%。在本续文中，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相关的更广泛的措施，包括肌肉面积，密度， 和力量，以及姿势的稳定性。这也将增加我们对主要骨骼结果的把握度， 如果不延长一年，这个比例将只有41%。试验的DSMB已 建议不揭盲当前研究的任何方面，并支持VIBES的扩展 审判这项临床试验的首要假设是，LMMS将对骨骼、肌肉、 和独立生活的老年人样本中的姿势稳定性。因此，该项目的首要目标是 通过评估系列定量计算，确定LMMS在三年内对骨骼的影响， 髋关节和脊柱体积骨小梁密度（vTBMB）的断层扫描（QCT）测量， 老年受试者已经参加了最初的两年研究。在试验期间，我们开发了一种新的 检查我们的髋关节QCT扫描的肌肉面积和密度的方法，并已收集其他 最初未纳入试验的指标，即下肢肌力和姿势 使用平衡平台的稳定性。这提供了第二个目标所依据的数据。我们假设 LMMS将导致改善肌肉面积，密度和力量，并将改善平衡。正在进行的 试验在老年人社区已经建立，研究小组有成功的记录， 到目前为止还没有安全问题。因此，现在有机会继续审判， 额外的一年，并测试围绕这种独特的非药物干预的多种假设。

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.