Vibration Intervention for Bone Enhancement in Childhood Cancer Survivors

描述（由申请人提供）：儿童癌症的治疗干扰了正常的骨成熟，使得一些儿童癌症幸存者可能永远无法达到骨量的最大峰值。在成人中，骨密度缺陷通常通过药物干预来解决，其长期安全性仍不确定。在儿童癌症幸存者中，目前正在进行一项评估补充维生素D和钙对所有幸存者有效性的随机试验；然而，为这一高危人群提供的其他干预措施很少。药物干预没有考虑到骨骼对外部环境提供的机械刺激的反应性。最近的证据表明，低强度、高频率的机械刺激可以改善骨的数量和质量，可能为有风险的个体提供了一种替代或辅助药物干预的方法，在这些人群中，额外的药物治疗是禁忌的或不可接受的。有必要对这种低负担干预措施的潜力进行评估。本申请提出了一项前瞻性双盲随机临床试验，对骨密度低于其年龄和性别平均值一个或多个标准差的儿童癌症幸存者进行低强度、高频机械（LMHF）刺激。在为期一年的试验中，将参与者平行分配到干预组或对照组。在整个试验期间，参与者将被要求每天两次站在“振动板”上10分钟。控制组的参与者将站在一个安慰剂装置上，该装置包含一个模仿振动处声音的语音盒。如果干预组在骨密度（BMD）方面表现出显著的改善，那么在研究结束时，对照组的参与者将接受干预。

DESCRIPTION (provided by applicant): Treatment for childhood cancer interferes with normal bone maturation such that maximal peak bone mass may never be attained by some survivors of childhood cancer. In adults, deficits in bone mineral density are usually approached via pharmacologic intervention, the long term safety of which remains uncertain. In childhood cancer survivors, a randomized trial evaluating the effectiveness of vitamin D and calcium supplementation among ALL survivors is currently underway; however, few other interventions have been offered for this at risk population. Pharmacologic interventions do not take into account the responsiveness of bone to mechanical stimuli provided by the external environment. Recent evidence demonstrates that low magnitude, high frequency mechanical stimulation can improve bone quantity and quality, perhaps providing an alternative or adjunct to pharmacologic intervention in populations where additional medications are either contraindicated or not acceptable to the individuals at risk. There is a need for an evaluation of the potential of this low burden intervention. This application proposes a prospective double blind randomized clinical trial of low magnitude, high frequency mechanical (LMHF) stimulation for childhood cancer survivors whose bone mineral density is one or more standard deviations below the mean for their age and gender. A two arm parallel allocation of participants to either the intervention or control group will be utilized for a one year trial. Participants will be asked to stand on a "vibrating plate" for 10 minutes twice per day during the entire year of the trial. Participants in the control arm will stand on a placebo device that contains a voice box that mimics the sound of the vibrating place. If the intervention arm demonstrates significant improvement in bone mineral density (BMD), participants in the control arm will be offered the intervention at the conclusion of the study. PUBLIC HEALTH RELEVANCE: Interventions to improve BMD and prevent early onset osteoporosis and fracture are essential to promote long, productive lives, free from persistent pain and/or disability. Current treatments for BMD decrements among childhood cancer survivors are limited to those who can tolerate a pharmacologic agent, and to those whose physical abilities allow a vigorous weight bearing physical activity. This innovative intervention is portable, safe, cost-effective, and of low burden to the cancer survivor. It has the potential to be used either alone or as an adjunct to other interventions to improve BMD in this at risk population.