Bone Health in Pediatric Crohn Disease: A Low Magnitude Mechanical Stimulus Trial

儿童克罗恩病的骨骼健康：低强度机械刺激试验

基本信息

批准号：
7663860
负责人：
Mary Beth Leonard
金额：
$ 55.04万
依托单位：
CHILDREN'S HOSP OF PHILADELPHIA
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-08-01 至 2011-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7663860
关键词：
Adherence Adolescence Adolescent Adult Adverse effects Animals Architecture Area Bone Density Calcium Cerebral Palsy Child Childhood Chronic Chronic Disease Consensus Consensus Development Conferences Coupled Crohn&apos s disease Data Delayed Puberty Devices Diagnosis Dimensions Disease Double-Blind Method Electronics Enrollment Exposure to Failure Female Adolescents Fracture Gender Glucocorticoids Growth Health Incentives Inflammatory Intervention Life Malnutrition Measures Mechanics Modems Monitor Muscle Muscle Contraction Osteogenesis Osteoporosis Osteoporosis prevention Physical activity Pilot Projects Placebo Control Placebos Production Psychologist Public Health Race Randomized Randomized Clinical Trials Recording of previous events Relative (related person)Reporting Research Research Personnel Risk Risk Factors Sexual Maturation Signal Transduction Skeletal Development Skeleton Staging Stimulus United States National Institutes of Health Vertebral column Vitamin D Weight-Bearing state Work X-Ray Computed Tomography bone bone health bone mass bone strength cytokine density disease characteristic effective therapy monitoring device muscle form prepuberty prevent programs randomized placebo controlled trial response skeletal tibia treatment effect

项目摘要

DESCRIPTION (provided by applicant): Skeletal growth is characterized by gender-, maturation-, and race- specific increases in cortical dimensions and trabecular volumetric bone mineral density (vBMD). Children with Crohn disease (CD) have numerous risk factors for impaired bone accrual, including poor growth, delayed puberty, malnutrition, glucocorticoid therapy and increased bone-resorptive cytokines. We reported that children with CD had significant deficits in trabecular vBMD, cortical dimensions and muscle mass; bone deficits were strongly associated with muscle deficits. No trials of anabolic or anti-resorptive bone therapies have been conducted in chronic pediatric inflammatory diseases. The capacity to increase bone mass and dimensions in response to mechanical loading is greatest during growth. Recent studies demonstrate that brief daily exposure to low magnitude mechanical stimuli (LMMS) enhances bone mass and quality. This revised application includes pilot data in 12 children with CD, demonstrating excellent adherence and no adverse effects. The proposed 12 month double blind, placebo controlled randomized trial will evaluate daily 10 minute treatments with , LMMS in 160 children with CD. Trabecular vBMD, cortical dimensions, and muscle area will be measured by quantitative computed tomography (QCT). The LMMS device monitors adherence; these data will be transmitted by modem to the psychologist who will work closely with subjects to optimize adherence. All subjects will be provided with calcium and vitamin D supplements. The primary aims are to determine if treatment with LMMS results in increased trabecular vBMD (tibia and spine) and increased cortical dimensions (tibia) in children with CD, compared with controls. Secondary analyses will examine (1) the effect of LMMS on the functional muscle-bone unit, (2) the impact of pubertal stage, physical activity (as measured by accelerometry), and disease characteristics (e.g. glucocorticoid therapy) on the response to LMMS, (3) the sensitivity of DXA to detect treatment effects, and (4) changes in bone and muscle over 12 months off therapy following completion of the trial in the subjects randomized to active devices. Public Health Statement: Childhood bone accrual is a critical determinant of life-long skeletal health. The NIH Osteoporosis Consensus Statement called for studies to identify interventions that promote bone health in children at risk. LMMS may provide a safe and effective treatment for myriad chronic pediatric diseases.

描述（由申请人提供）：骨骼生长的特征是性别，成熟和种族特异性的皮质维度和小梁体积骨矿物质密度（VBMD）的特征。克罗恩病（CD）儿童具有众多骨骼应计的危险因素，包括生长不良，青春期延迟，营养不良，糖皮质激素治疗和骨头敏感性细胞因子的增加。我们报道了CD儿童在小梁VBMD，皮质维度和肌肉质量中存在明显缺陷。骨缺陷与肌肉缺陷密切相关。在慢性小儿炎症性疾病中尚未对合成代谢或抗敏感性骨疗法进行试验。在生长过程中，增加骨骼质量和对机械负荷的尺寸的能力最大。最近的研究表明，每天短暂暴露于低幅度的机械刺激（LMM）会增强骨骼质量和质量。该修订的应用程序包括12名患有CD的儿童的试验数据，表明依从性很高，没有不利影响。拟议的12个月双盲，安慰剂对照的随机试验将评估160名CD儿童的LMMS每日治疗。小梁VBMD，皮质尺寸和肌肉区域将通过定量计算机断层扫描（QCT）测量。 LMMS设备监视依从性；这些数据将由调制解调器传输给心理学家，他们将与受试者紧密合作以优化依从性。所有受试者都将为钙和维生素D补充剂提供。与对照组相比，主要目的是确定使用LMM的治疗是否导致小梁VBMD（胫骨和脊柱）增加增加，以及CD儿童的皮质尺寸（胫骨）增加。次级分析将检查（1）LMM对功能性肌肉骨单位的影响，（2）青春期阶段，体育活动，体育锻炼（通过加速度计测量）和疾病特征（例如，糖皮质激素治疗）对LMMS响应的影响（例如，糖皮质激素治疗）对LMMS的响应，（3）在处理治疗的敏感性和培训中的敏感性（3）跨度（3）均为thection the Exterivition the Exterion the Extirion the Inter the Inter the Inter the Inter（4）何时（4）inter（4），（4）何种（4）的效果（4）。受试者随机分配到活动设备。公共卫生声明：儿童骨骼应计是终生骨骼健康的关键决定因素。 NIH骨质疏松症共识声明要求研究确定促进有风险儿童骨骼健康的干预措施。 LMM可以为无数慢性小儿疾病提供安全有效的治疗方法。