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临床试验/NCT02638922
NCT02638922Unknown不适用

Evaluation of 304 Danish Girls With Tall Stature: Phenotypic Characteristics and Effects of Oral Administration of Natural 17β-Estradiol

Rigshospitalet, Denmark0 个研究点目标入组 304 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
304
主要终点
final height

研究概览

简要总结

Objective

To evaluate the phenotypic characteristics and diagnoses in a large cohort of 304 consecutive girls referred due to tall stature. Furthermore, to evaluate the effect of oral administration of 17β-estradiol on predicted adult height in constitutionally tall statured girls.

Design

A single-centre retrospective observational study of 304 girls evaluated due to tall stature between 1993 and 2013.

Setting

Tertiary referral centre for pediatric endocrinology.

Participants

A total of 304 girls were evaluated for tall stature of whom 39 (13%) were excluded due to missing data, reclassification, overgrowth syndromes or associated comorbidities. Another 58 (19%) girls did not fulfil auxological criteria for constitutionally tall stature (CTS), resulting in a total of 207 (68%) girls eligible for analysis.

Main Outcome Measures

The effect of oral treatment with 17β-estradiol on height, predicted adult height (PAH), final height and circulating hormones in constitutional tall statured girls.

详细描述

17α-ethinylestradiol (EE2) treatment of extreme tall stature has become increasingly debated and controversial. In Sweden, percutaneous epiphysiodesis operation is suggested as an alternative to EE2 treatment. An alternative clinical practise was introduced 20 years ago, when early treatment with oral administration of natural estrogens (17β-estradiol (E2)) was introduced in order to initiate or ensure rapid progression of puberty (and epiphyseal closure) in tall statured girls.

A retrospective 20-year single center experience included evaluation of 304 tall statured girls and the possible clinical effects of oral administration of E2.

Subjects and methods

Patients

The patient population consisted of girls who were referred with tall stature or overgrowth syndromes (ICD10 34.4, and ICD10 DE874, DQ970, DQ873A, DQ873B) to the Department of Growth and Reproduction at Rigshospitalet in Copenhagen, Denmark, during a 20-years period (between 1993 and 2013). A total of 304 patients were identified, and the diagnoses were re-evaluated as part of the present study.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • tall stature (height > 2 SD)

排除标准

  • 未提供

研究组 & 干预措施

Estradiol treatment

girls who received estradiol treatment

干预措施: Estradiol (Drug)

结局指标

主要结局

final height

时间窗: 10 year observation time

attainment of final height

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anders Juul

Professor

Rigshospitalet, Denmark

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Evaluation and Treatment of Tall Statured Girls | 临床试验