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

点击翻译按钮获取中文摘要

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.