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; 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资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。特纳综合征（TS）中的雌激素替代是使用雌激素制剂最常见的。基于初步数据，我们假设透皮雌二醇与口服雌二醇对近最终成人高度（FAH）和接近峰值骨质量（PBM）在生长激素（GH）处理过TS的青少年中的影响更大。该研究的目的是评估透皮和口服雌激素对生长和骨骼质量的影响，以及它们与生长因子水平，骨转换和性类固醇水平的相关性。这两年有选择性随机的前瞻性研究涉及两个治疗组：等效剂量的口服雌二醇与标准生长激素治疗结合使用。 12-15岁的TS青少年将按骨骼年龄选择性地随机分配给每组。在两组中，模仿正常青春期的两年中，雌激素剂量将逐渐增加一次。每组样本量为12，测试显着性水平为0.05，我们将具有80％的功率来检测两组的增长差异25％。在骨骼质量方面，没有初步数据来评估两组之间的标志性差异样本量估计。通过重复测量方差分析，将对结果度量进行统计分析。