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Evaluation and Treatment of Tall Statured Girls (TallgirlsDK)

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ClinicalTrials.gov Identifier: NCT02638922
Recruitment Status : Unknown
Verified April 2016 by Anders Juul, Rigshospitalet, Denmark.
Recruitment status was:  Active, not recruiting
First Posted : December 23, 2015
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Anders Juul, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment
Constitutional Tall Stature Drug: Estradiol

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 304 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Evaluation of 304 Danish Girls With Tall Stature: Phenotypic Characteristics and Effects of Oral Administration of Natural 17β-Estradiol
Study Start Date : January 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Group/Cohort Intervention/treatment
no treatment
girls who never received estradiol treatment
Estradiol treatment
girls who received estradiol treatment
Drug: Estradiol
Estradiol containing compounds administered orally in a non-randomized manner.
Other Names:
  • Estradiol (Trisekvens®, Novo Nordisk, Denmark),
  • Estradiol (Trisekvens Forte®, Novo Nordisk, Denmark)
  • Estradiol (Femanest®, Sandoz A/S, Denmark)




Primary Outcome Measures :
  1. final height [ Time Frame: 10 year observation time ]
    attainment of final height



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients registered in our tertiary referral centre included
Criteria

Inclusion Criteria:

  • tall stature (height > 2 SD)

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638922


Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Anders Juul, MD Rigshospitalet, Denmark
Principal Investigator: Emmie Upners, student Rigshospitalet, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anders Juul, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02638922     History of Changes
Other Study ID Numbers: RH-2015-218-04161
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Trisequens
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral