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Follow-up of Girls With Premature Thelarche and Precocious Puberty

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Mia Elbek Sømod, University of Aarhus.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01944475
First Posted: September 17, 2013
Last Update Posted: September 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aarhus University Hospital Skejby
Information provided by (Responsible Party):
Mia Elbek Sømod, University of Aarhus
  Purpose
Precocious puberty - the onset of signs of puberty before 8 years of age in girls - is be physically and emotionally devastating for kids and is sometimes caused by an underlying and medical condition. One sign of precocious puberty in small girls is breast development (thelarche). This can persist without other physical changes of puberty, it may continue into precocious puberty, or it may disappear. This project will improve the diagnostics of precocious puberty in girls and improve our ability to identify which girls with thelarche, who will develop precocious puberty and need medical treatment.

Condition
Precocious Puberty Excess; Development, Breast

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Target Follow-Up Duration: 1 Day
Official Title: Follow-up of Girls With Premature Thelarche and Precocious Puberty: a Clinical and Paraclinical Study of Girls With Thelarche and Healthy Controls

Resource links provided by NLM:


Further study details as provided by Mia Elbek Sømod, University of Aarhus:

Primary Outcome Measures:
  • Tanner stage (breast and pubic hair) [ Time Frame: Up till age 21.0 years ]

Secondary Outcome Measures:
  • weight [ Time Frame: up till age 21.0 years ]
  • height [ Time Frame: Up till age 21.0 years ]
  • Bone age [ Time Frame: Up till age 21.0 years ]
  • LH-peak after GnRH-test [ Time Frame: Up till age 21.0 years ]
  • Hormones (estrogen, prolactin, 17OHP, androstrendion, DHEA, testosterone, inhibin B, SHBG, AFP, kisspeptin, HCG, thyroid hormones) [ Time Frame: Up till age 21.0 years ]
  • Ultrasound of the internal genitalia [ Time Frame: Up till age 21.0 years ]

Other Outcome Measures:
  • Exposure [ Time Frame: Up till age 21.0 years ]

Biospecimen Retention:   Samples With DNA
GnRH test, p-estrogen, p-testosterone , p-SHBG, p- androstenedione, p-dihydroandrostendion, p-inhibin B, p-thyroid parameters, ultrasound examination of the genitalia interna and a blood sample for studies of polymorphism in the estrogen receptor gene and aromatase enzyme gene.

Estimated Enrollment: 50
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
0-6 year old girls diagnosed with premature thelarche or precocious puberty from 1998 to today at the Children's Section A, AUH, Skejby. Girls who are 8 years old or under at baseline (1st of september) will be contacted and asked to participate in a clinical and paraclinical re-examination.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of precocious puberty or premature thelarche
  • 0-6 year old girls at time of diagnosis for the medical record review
  • 0-8 year old girls at baseline for the re-examination

Exclusion Criteria:

  Contacts and Locations
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): NCT01944475


Contacts
Contact: Niels H Birkebæk, Dr.med, PhD +45 50860090 nielbirk@rm.dk
Contact: Mia E Sømod, Stud. med +45 60199810 mia.elbek.somod@studmed.au.dk

Locations
Denmark
Børneafdelingen A, AUH, Skejby Not yet recruiting
Aarhus N, Denmark, 8200
Contact: Niels H. Birkebæk, Dr.med, PhD    +45 50860090    nielbirk@rm.dk   
Contact: Mia E. Sømod, Stud.med    45 60199810    mia.elbek.somod@studmed.au.dk   
Principal Investigator: Niels H. Birkebæk, MD PhD         
Principal Investigator: Esben T. Vestergaard, MD PhD         
Principal Investigator: Kurt Kristensen, MD PhD         
Principal Investigator: Mia E. Sømod, Stud.med         
Børneafdelingen A, AUH, Skejby Not yet recruiting
Aarhus N, Denmark, 8200
Contact: Niels H. Birkebæk, Dr.med, PhD    +4550860090    nielbirk@rm.dk   
Contact: Mia E. Sømod, Stud.med    +4560199810    mia.elbek.somod@studmed.au.dk   
Principal Investigator: Niels H. Birkebæk, Dr.med, PhD         
Principal Investigator: Esben T. Vestergaard, Dr.med, PhD         
Principal Investigator: Kurt Kristensen, Dr.med, PhD         
Principal Investigator: Mia E. Sømod, Stud.med         
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital Skejby
Investigators
Principal Investigator: Niels H. Birkebæk, MD PhD Børneafdeling A, AUH, Skejby
Principal Investigator: Esben T. Vestergaard, MD, PhD Børneafdeling A, AUH, Skejby
Principal Investigator: Kurt Kristensen, MD, PhD Børneafdeling A, AUH, Skejby
Principal Investigator: Mia E. Sømod, Stud.med Børneafdeligen A, AUH, Skejby
  More Information

Publications:
Carel JC, Léger J. Clinical practice. Precocious puberty. N Engl J Med. 2008 May 29;358(22):2366-77. doi: 10.1056/NEJMcp0800459. Review.
Carel JC, Lahlou N, Roger M, Chaussain JL. Precocious puberty and statural growth. Hum Reprod Update. 2004 Mar-Apr;10(2):135-47. Review.
Tremblay L, Frigon JY. Precocious puberty in adolescent girls: a biomarker of later psychosocial adjustment problems. Child Psychiatry Hum Dev. 2005 Fall;36(1):73-94.
Michaud PA, Suris JC, Deppen A. Gender-related psychological and behavioural correlates of pubertal timing in a national sample of Swiss adolescents. Mol Cell Endocrinol. 2006 Jul 25;254-255:172-8. Epub 2006 Jun 27.
Herman-Giddens ME, Slora EJ, Wasserman RC, Bourdony CJ, Bhapkar MV, Koch GG, Hasemeier CM. Secondary sexual characteristics and menses in young girls seen in office practice: a study from the Pediatric Research in Office Settings network. Pediatrics. 1997 Apr;99(4):505-12.
Teilmann G, Pedersen CB, Jensen TK, Skakkebaek NE, Juul A. Prevalence and incidence of precocious pubertal development in Denmark: an epidemiologic study based on national registries. Pediatrics. 2005 Dec;116(6):1323-8.
Houk CP, Kunselman AR, Lee PA. The diagnostic value of a brief GnRH analogue stimulation test in girls with central precocious puberty: a single 30-minute post-stimulation LH sample is adequate. J Pediatr Endocrinol Metab. 2008 Dec;21(12):1113-8.
Curfman AL, Reljanovic SM, McNelis KM, Dong TT, Lewis SA, Jackson LW, Cromer BA. Premature thelarche in infants and toddlers: prevalence, natural history and environmental determinants. J Pediatr Adolesc Gynecol. 2011 Dec;24(6):338-41. doi: 10.1016/j.jpag.2011.01.003.
Atay Z, Turan S, Guran T, Furman A, Bereket A. The prevalence and risk factors of premature thelarche and pubarche in 4- to 8-year-old girls. Acta Paediatr. 2012 Feb;101(2):e71-5. doi: 10.1111/j.1651-2227.2011.02444.x. Epub 2011 Sep 23.
de Vries L, Guz-Mark A, Lazar L, Reches A, Phillip M. Premature thelarche: age at presentation affects clinical course but not clinical characteristics or risk to progress to precocious puberty. J Pediatr. 2010 Mar;156(3):466-71. doi: 10.1016/j.jpeds.2009.09.071. Epub 2009 Nov 14.

Responsible Party: Mia Elbek Sømod, Research assistamt, University of Aarhus
ClinicalTrials.gov Identifier: NCT01944475     History of Changes
Other Study ID Numbers: 1-10-72-186-13
First Submitted: September 5, 2013
First Posted: September 17, 2013
Last Update Posted: September 17, 2013
Last Verified: September 2013

Keywords provided by Mia Elbek Sømod, University of Aarhus:
Precocious puberty
Premature thelarche
Tanner-stage
GnRH-test

Additional relevant MeSH terms:
Premature Birth
Puberty, Precocious
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Gonadal Disorders
Endocrine System Diseases


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