Low Magnitude Mechanical Stimulation to Improve BMD

描述(申请人提供)：老年人骨折的预防主要集中在抑制骨吸收的药物干预上。需要非药物方法来改善整个肌肉骨骼系统，并最终降低骨折风险，这构成了我们正在进行的被称为“VIBES”试验的低幅度机械刺激(LMMS)随机、双盲、安慰剂对照试验竞争性继续的基础。这项试验始于2007年，目的是研究LMM对骨骼的影响，该试验随机抽取了最初目标为200名老年参与者中的174名，依从率为80%。在此基础上，我们建议将研究干预和随访延长一年，并通过考虑与肌肉骨骼健康相关的更广泛的指标来扩大科学的范围，包括肌肉面积、密度、力量和姿势稳定性。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，初级骨骼结果将只有41%。试验的dsmb建议不要使当前研究的任何方面变得盲目，并支持扩大Vibe试验。这项临床试验的主要假设是，在独立生活的老年人样本中，LMMs将对骨骼、肌肉和姿势稳定性产生有利影响。因此，该项目的第一个目标是通过评估已经参加最初两年研究的老年受试者髋部和脊柱的体积骨小梁密度(VTBMB)的一系列定量计算机断层扫描(QCT)测量，来确定LMM在三年期间对骨骼的影响。在试验期间，我们开发了新的方法来检查我们的髋部QCT扫描的肌肉面积和密度，并一直在收集最初不包括在试验中的其他指标，即使用平衡平台的腿部肌肉力量和姿势稳定性。这提供了第二个目标所基于的数据。我们假设，LMMS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建立得很好，研究小组有成功的记录，到目前为止还没有安全问题。因此，现在有机会继续试验一年，并测试围绕这一独特的非药物干预的多个假说。 公共卫生相关性：老年人骨折的预防主要集中在抑制骨丢失的药物治疗上。这项对居住在马萨诸塞州波士顿周围16个退休社区的174名老年受试者进行的低幅度机械刺激(LMMS)临床试验(使用0.3g@30赫兹，10分钟/天的LMMS)旨在测试一种多维的、非药物的方法来改善整体肌肉骨骼系统(骨骼、肌肉和平衡)。这项研究的意义在于，它将测试这种独特的干预措施的有效性，以改善肌肉骨骼系统中导致骨折风险的多种成分。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: The prevention of fractures in the aged population are largely focused on drug therapy to inhibit bone loss. This clinical trial of low magnitude mechanical stimulation (LMMS) in 174 elderly subjects residing in 16 retirement communities around Boston, MA (using 0.3g @ 30Hz, 10 min/d of LMMS) is intended to test a multidimensional, non-drug approach to improving the musculoskeletal system as a whole (bone, muscle, and balance). The significance of the study is that it will test the efficacy of this unique intervention to improve multiple components of the musculoskeletal system that contribute to fracture risk.