Clinical Trial: Evaluation and Treatment of Tall Statured Girls

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

Brief Summary:

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.

Detailed Summary:

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.

Clinical data and medical history

Medical history was obtained using a structured review of patient record files. Clinical data on pubertal development were obtained from each patient visit. Puberty was evaluated by inspection and palpation of the breasts and s pubic hair according to Marshall and Tanner. A wall-mounted stadiometer (Holtain Ltd., Crymych, United Kingdom) was used to measure standing height to the nearest 0.1 cm. The girls were weighed on a digital electronic scale (Seca delta, model 707; Seca, Hamburg, Germany) with a precision of 0.1 kg while wear
Sponsor: Rigshospitalet, Denmark

Current Primary Outcome: final height [ Time Frame: 10 year observation time ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Rigshospitalet, Denmark

Dates:
Date Received: December 13, 2015
Date Started: January 2014
Date Completion: December 2017
Last Updated: April 5, 2016
Last Verified: April 2016