Follow-up of Girls With Premature Thelarche and Precocious Puberty

September 12, 2013 updated by: Mia Elbek Sømod, University of Aarhus

Follow-up of Girls With Premature Thelarche and Precocious Puberty: a Clinical and Paraclinical Study of Girls With Thelarche and Healthy Controls

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

The purpose of the study is

  1. To conduct an epidemiological study in which characteristics of 0-6 year-old girls with either premature thelarche or precocious puberty are described (as specified below)
  2. To conduct a clinical and para-clinical re-examination of the before-mentioned (1))0-6 year-old girls
  3. To compare the clinical and paraclinical parameters in point 1) mentioned 0-6 year-old girls with a control group of children at the same age, whiteout thelarche and precocious puberty. (Local Ethics Committee has approved the study of the control group, case number 1-10-72-631-12.)

The study includes a chart review of registered 0-6 year-old girls diagnosed with premature thelarche or precocious puberty from 1998 and until today at Dept. of Pediatrics A, AUH Skejby. The cohort has not earlier been examined and the number of girls in the cohort is estimated from our clinical experience with this patient group to be about 50 in total. The following characteristics from the patients records will be registered in a database:

Age at diagnosis, anthropometry (height and weight), Tanner stage - breast, Tanner stage - pubic hair, GnRH test (LH and FSH response), thyroid parameters, estrogen, prolactin, 17OHP, androstenedione, dihydroepiandrosteron (DHEA), testosterone, inhibin B, SHBG, AFP, kisspeptin, human chorionic gonadotropin (HCG), bone age, MRI of the cerebrum, US of internal genitalia, and exposures to environmental chemicals known to affect secondary sex characteristics.

The database will be developed in the program Access. The results will be reported as mean and standard deviation and minimum and maximum values for each age group by Tanner stage, if the data are normally distributed. Non-normally distributed data will be given as median and confidence intervals as well as minimum and maximum values for each Tanner stage. Data for previously studied children with suspected precocious puberty, will be reported in the same way. Statistical comparison between the groups will be made with u-paired t-test or equivalent non-parametric test, if the data is not normally distributed.

The Data Unit at Aarhus University Hospital, Skejby, identifies 0-6 year-old girls with diagnoses premature thelarche or precocious puberty in 1998 and onwards. Girls below 8 years of age at baseline of the project (1st of September 2013) will be contacted and requested to participate in a re-examination.

The follow-up is a clinical and paraclinical re-examination, where the following parameters are measured: anthropometry (height and weight), skinfold thickness, Tanner stage, bone age, 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.

If the girls are unable or unwilling to attend the reexamination, they are requested to fill out a questionnaire instead as follows:

  • name, social security number, date of completion the questionnaire
  • current height, current weight, birth weight, origin
  • date of onset of puberty if started, current pubertal development, menarche
  • diseases/admissions

Regarding the mother:

- age at menarche, medicine during pregnancy/breastfeeding, diet during pregnancy/breastfeeding, use of cosmetics /cream/shampoo during pregnancy,

Regarding the family:

- others with early breast development/early puberty

The project is conducted at Dept. of Pediatrics A, Aarhus University Hospital, Skejby, Skejbygårdsvej 100, 8200 Aarhus N. The other pediatric wards in the Region of Midtjylland (located in Randers, Viborg and Herning) will be included in the project if they prefer to participate.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Niels H Birkebæk, Dr.med, PhD
  • Phone Number: +45 50860090
  • Email: nielbirk@rm.dk

Study Contact Backup

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Børneafdelingen A, AUH, Skejby
        • Principal Investigator:
          • Mia E. Sømod, Stud.med
        • Contact:
          • Niels H. Birkebæk, Dr.med, PhD
          • Phone Number: +4550860090
          • Email: nielbirk@rm.dk
        • Contact:
        • Principal Investigator:
          • Niels H. Birkebæk, Dr.med, PhD
        • Principal Investigator:
          • Esben T. Vestergaard, Dr.med, PhD
        • Principal Investigator:
          • Kurt Kristensen, Dr.med, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tanner stage (breast and pubic hair)
Time Frame: Up till age 21.0 years
Up till age 21.0 years

Secondary Outcome Measures

Outcome Measure
Time Frame
weight
Time Frame: up till age 21.0 years
up till age 21.0 years
height
Time Frame: Up till age 21.0 years
Up till age 21.0 years
Bone age
Time Frame: Up till age 21.0 years
Up till age 21.0 years
LH-peak after GnRH-test
Time Frame: Up till age 21.0 years
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
Up till age 21.0 years
Ultrasound of the internal genitalia
Time Frame: Up till age 21.0 years
Up till age 21.0 years

Other Outcome Measures

Outcome Measure
Time Frame
Exposure
Time Frame: Up till age 21.0 years
Up till age 21.0 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ANTICIPATED)

September 1, 2014

Study Completion (ANTICIPATED)

September 1, 2014

Study Registration Dates

First Submitted

September 5, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (ESTIMATE)

September 17, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-186-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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