Vibration Intervention for Bone Enhancement in Childhood Cancer Survivors

振动干预促进儿童癌症幸存者骨质增强

• 批准号: 8037771
• 负责人: Kirsten Kimberlie Ness
• 金额: $ 13.18万
• 依托单位: ST. JUDE CHILDREN'S RESEARCH HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-03-04 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8037771
• 关键词: Accounting; Adult; Age; Alkaline Phosphatase; Bone Density; Bone Mineral Contents; Bone Tissue; Calcium; Cancer Survivor; Childhood; Collagen Type I; Control Groups; Devices; Double-Blind Method; Effectiveness; Environment; Evaluation; Fracture; Frequencies; Gender; Height; Individual; Intervention; Larynx; Ligands; Malignant Childhood Neoplasm; Mechanical Stimulation; Mechanics; Nuclear; Osteocalcin; Osteoporosis; Participant; Persistent pain; Pharmaceutical Preparations; Phosphoric Monoester Hydrolases; Physical activity; Placebos; Population; Populations at Risk; Randomized; Randomized Clinical Trials; Resistance; Risk; Safety; Spinal; Stimulus; Stress; Supplementation; Survivors; Tartrates; Tumor necrosis factor receptor 11b; Type I Procollagen; Vitamin D; Weight-Bearing state; arm; bone; bone mass; bone strength; bone turnover; childhood cancer survivor; cost effective; design; disability; early onset; improved; innovation; prevent; prospective; public health relevance; randomized trial; receptor; sound; vibration

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.

描述（由申请人提供）：儿童癌症的治疗会干扰正常的骨成熟，使得一些儿童癌症的幸存者可能永远无法达到最大峰值骨量。在成人中，骨矿物质密度缺陷通常通过药物干预来解决，但其长期安全性仍不确定。在儿童癌症幸存者中，目前正在进行一项随机试验，评估维生素 D 和钙补充剂在 ALL 幸存者中的有效性；然而，针对这一高危人群几乎没有采取其他干预措施。药物干预没有考虑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量和质量，或许可以为高危个体禁忌或不接受其他药物的人群提供药物干预的替代方案或辅助手段。有必要评估这种低负担干预措施的潜力。本申请提出了一项针对儿童癌症幸存者的低幅度、高频机械（LMHF）刺激的前瞻性双盲随机临床试验，这些儿童的骨矿物质密度比其年龄和性别的平均值低一个或多个标准差。将参与者平行分配到干预组或对照组，进行为期一年的试验。在整个试验年中，参与者将被要求每天两次站在“振动盘”上，每次 10 分钟。控制臂上的参与者将站在安慰剂设备上，该设备包含一个模仿振动位置声音的语音盒。如果干预组表现出骨矿物质密度 (BMD) 显着改善，则对照组的参与者将在研究结束时接受干预。 公共卫生相关性：改善骨密度和预防早发性骨质疏松症和骨折的干预措施对于促进长寿、富有成效的生活、免受持续性疼痛和/或残疾至关重要。目前针对儿童癌症幸存者 BMD 下降的治疗仅限于那些能够耐受药物的患者，以及那些身体能力允许进行剧烈负重体力活动的患者。这种创新的干预措施便携、安全、具有成本效益，并且对癌症幸存者的负担低。它有可能单独使用或作为其他干预措施的辅助手段，以改善高危人群的骨密度。

项目成果

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• DOI: 10.3390/nu7125499
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