GTP and Tai Chi for Bone Health: a Pilot Study

描述(申请人提供)：骨质疏松症是绝经后妇女的主要健康问题。我们的长期目标是开发一种新的补充和替代医学(CAM)策略，包括饮食补充和身心锻炼，以缓解绝经后骨量低的女性的骨丢失。目的：测试包括绿茶多酚(GTP)和太极(TC)运动在内的CAM干预措施的可行性，并定量评估其对绝经后骨量减少妇女的个体和联合作用。假说：(1)与仅服用安慰剂相比，24周补充GTP、TC运动及其组合将有利于绝经后骨量减少妇女的骨生物标记物测量的骨重建，(2)与骨重建相关的骨生物标记物的变化将与氧化应激的变化相关。具体目标是： 1.对140名患有骨量减少的绝经后妇女进行为期24周的随机、安慰剂对照干预试验。研究参与者将被分配到4个治疗组：(1)安慰剂对照组，每天接受药用淀粉片；(2)GTP组，每天接受1000毫克GTP；(3)安慰剂+TC组，同时接受安慰剂治疗和TC训练(60分钟小组锻炼，每周3次)；(4)GTP+TC组，同时接受GTP和TC治疗，为期24周。在干预期间，所有参与者每天将获得1000毫克的元素钙和400国际单位的维生素D。我们将评估累计率、保留和遵从性、不良事件、干预措施的交付、纳入/排除标准的适当性，以及计划临床试验的整体方案设计的优化。 2.评价GTP、TC及其联合干预对骨转换和DNA损伤氧化应激生物标志物在基线、6周、12周和24周的影响。骨转换生物标记物将包括骨形成生物标记物(血清骨碱性磷酸酶)和骨吸收生物标记物(尿I型胶原交联N-(NTX))。DNA氧化损伤的生物标志物将是尿中的8-羟基-2‘-脱氧鸟苷(8-OHdG)。将采用具有随机影响误差项的重复测量模型。传统的方法，如单因素方差分析、卡方分析、回归和双变量相关等也将用于比较。 意义：这项研究将产生一种新的替代康复疗法，已被证明对绝经后骨量低的妇女有抗骨质疏松的好处。

DESCRIPTION (provided by applicant): Osteoporosis is a major health problem in postmenopausal women. Our long-term goal is to develop a new complementary and alternative medicine (CAM) strategy featuring a dietary supplement and a mind-body exercise for alleviating bone loss in postmenopausal women with low bone mass. Objective: To test a CAM intervention including green tea polyphenol (GTP) and Tai Chi (TC) exercise for feasibility, and to quantitatively assess their individual and conjugate effects on postmenopausal women with osteopenia. Hypotheses: (1) 24 weeks of GTP supplement, TC exercise, and their combination will benefit bone remodeling as measured by bone biomarkers in postmenopausal women with osteopenia compared to those receiving placebo only, and (2) the changes in bone biomarkers associated with bone remodeling will be correlated with the changes in oxidative stress. The specific aims are: 1. To perform a 24-week randomized and placebo-controlled intervention trial in 140 postmenopausal women with osteopenia. Study participants will be assigned to 4 treatment arms: (1) placebo control group receiving medicinal starch pills daily, (2) GTP group receiving 1000 mg of GTP per day, (3) placebo+TC group receiving both placebo treatment and TC training (60-minute group exercise, 3 times per week), and (4) GTP+TC group receiving both GTP and TC treatments for 24 weeks. During the intervention, all participants will be provided with 1000 mg of elemental calcium and 400 IU of vitamin D daily. We will evaluate accrual rate, retention and compliance, adverse events, delivery of the intervention, appropriateness of inclusion/exclusion criteria, and optimization of the overall protocol design for the planned clinical trial. 2. To evaluate the effects of GTP, TC and their combined interventions on bone turnover and DNA damage oxidative stress biomarkers at baseline, 6, 12 and 24 wks. The bone turnover biomarkers will include bone formation biomarker (serum bone alkaline phosphatase) and bone resorption biomarker (urinary type I collagen cross-linked N-(NTX)). The oxidative DNA damage biomarker will be 8-hydroxy-2'- deoxyguanosine (8-OHdG) in urine. A model of repeated measurements with random effect error terms will be applied. Traditional procedures such as ANCOVA, chi-squared analysis, regression, and bivariate correlation will also be used for comparisons. Significance: The study will result in a new alternative rehabilitation treatment with proven anti-osteoporotic benefits for postmenopausal women with low bone mass.