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: 7377312
• 负责人: SEVKET YIGIT
• 金额: $ 0.03万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7377312
• 关键词: TRANSDERMAL; VS; ORAL; ESTROGEN; 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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。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。根据初步数据，我们假设透皮雌二醇与口服雌二醇相比，对接受生长激素 (GH) 治疗的 TS 青少年的近最终成年身高 (FAH) 和近峰值骨量 (PBM) 具有更有利的影响。该研究的目的是评估透皮雌激素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：同等剂量的口服雌二醇与透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入各组。两年内，两组的雌激素剂量将每 6 个月逐渐增加，模仿正常青春期。每组的样本量为 12，检验显着性水平为 0.05，我们将有 80% 的功效来检测两组生长中 25% 的差异。目前尚无骨量方面的初步数据来评估两组之间是否存在显着差异的样本量估计。结果测量的统计分析将通过重复测量方差分析来完成。