Evaluation and Treatment of Tall Statured Girls

NCT02638922 | Unknown

• 1 other identifier: RH-2015-218-04161
• Study Type: observational
• Target: 304
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Constitutional Tall Stature

Outcome Measures

Primary Outcomes (1)

• final height

  attainment of final height

  10 year observation time

Study Arms (2)

no treatment

girls who never received estradiol treatment

Estradiol treatment

girls who received estradiol treatment

Drug: Estradiol

Interventions

Estradiol DRUG

Estradiol containing compounds administered orally in a non-randomized manner.

Also known as: Estradiol (Trisekvens®, Novo Nordisk, Denmark),, Estradiol (Trisekvens Forte®, Novo Nordisk, Denmark), Estradiol (Femanest®, Sandoz A/S, Denmark)

Estradiol treatment

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients registered in our tertiary referral centre included

You may qualify if:

• tall stature (height \> 2 SD)

You may not qualify if:

• none

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Related Publications (1)

• Upners EN, Juul A. Evaluation and phenotypic characteristics of 293 Danish girls with tall stature: effects of oral administration of natural 17beta-estradiol. Pediatr Res. 2016 Nov;80(5):693-701. doi: 10.1038/pr.2016.128. Epub 2016 Jun 20.

  PMID: 27410906 DERIVED

MeSH Terms

Interventions

Estradiol; Trisequens

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Anders Juul, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Emmie Upners, student

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 13, 2015
• First Posted: December 23, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 6, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share