TRANSDERMAL VS ORAL ESTROGEN THERAPY ON ADOLESCENTS WITH TURNER'S SYNDROME

特纳综合征青少年的透皮疗法与口服雌激素疗法

• 批准号: 7607586
• 负责人: SEVKET YIGIT
• 金额: $ 0.02万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7607586
• 关键词: Adolescent; Adult; Age; Analysis of Variance; Bone Growth; Computer Retrieval of Information on Scientific Projects Database; Data; Dose; Estradiol; Estrogen Replacements; Estrogen Therapy; Estrogens; Funding; Gonadal Steroid Hormones; Grant; Growth; Growth Factor; Height; Institution; Measures; Oral; Outcome Measure; Preparation; Prospective Studies; Puberty; Randomized; Research; Research Personnel; Resources; Sample Size; Significance Level; Somatotropin; Source; Standards of Weights and Measures; Testing; Turner' s Syndrome; United States National Institutes of Health; base; bone; bone turnover; hormone therapy

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Estrogen replacement in Turner Syndrome (TS) is accomplished most commonly using estrogen preparations. Based on preliminary data we hypothesize that transdermal vs. oral estradiol will have more favorable effect on near final adult height (FAH) and near peak bone mass (PBM) in growth hormone (GH) treated adolescents with TS. The aim of the study is to evaluate the effect of transdermal vs. oral estrogen on growth and bone mass and their correlation with growth factor levels, markers of bone turnover and sex steroid levels. This 2 year selectively randomized prospective study involves two treatment groups: equivalent doses of oral vs. transdermal estradiol in combination with standard growth hormone therapy. The TS adolescents ages 12-15 years will be selectively randomized to each group by bone age. Estrogen dose will be gradually increased every 6 months over the two years in both groups mimicking normal puberty. With a sample size of 12 in each group and test significance level of 0.05, we will have an 80% power to detect a 25% difference in growth of two groups. There is no preliminary data in terms of bone mass to evaluate sample size estimation for signigicant difference between two groups. Statistical analysis of outcome measures will be done with repeated measures analysis of variance.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 特纳综合征（TS）中的雌激素替代最常见的是使用雌激素制剂。基于初步数据，我们假设经皮与口服雌二醇相比，在生长激素（GH）治疗的TS青少年中，对接近最终成人身高（FAH）和接近峰值骨量（PBM）具有更有利的影响。本研究的目的是评估经皮与口服雌激素对生长和骨量的影响及其与生长因子水平、骨转换标志物和性类固醇水平的相关性。这项为期2年的选择性随机前瞻性研究涉及两个治疗组：同等剂量的口服与透皮雌二醇联合标准生长激素治疗。年龄为12-15岁的TS青少年将按骨龄选择性随机分配至各组。两组中雌激素剂量将在两年内每6个月逐渐增加，模拟正常青春期。每组样本量为12，检验显著性水平为0.05，我们将有80%的把握度检测到两组生长差异为25%。目前尚无关于骨量的初步数据来评估两组间样本量估计的显著性差异。将采用重复测量方差分析对结局指标进行统计分析。