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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。在特纳综合征（TS）中，雌激素替代是最常用的雌激素制剂。根据初步数据，我们假设经皮注射雌二醇比口服雌二醇对生长激素治疗的TS青少年的接近最终成人身高（FAH）和接近峰值骨量（PBM）有更有利的影响。本研究的目的是评估经皮注射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包括两个治疗组：等效剂量口服雌二醇与经皮雌二醇联合标准生长激素治疗。12-15岁的TS青少年将根据骨龄选择性随机分为各组。雌激素的剂量将在两年内每6个月逐渐增加，两组模拟正常的青春期。每组的样本量为12，检验显著性水平为0.05，我们将有80%的能力检测到两组的生长差异为25%。没有骨量方面的初步数据来评估两组之间的显著差异。结果测量的统计分析将通过重复测量方差分析来完成。

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.