Clinical Trial: Follow-up of Girls With Premature Thelarche and Precocious Puberty

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational [Patient Registry]

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

Brief Summary: 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.

Detailed Summary:

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 ea
Sponsor: University of Aarhus

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University of Aarhus

Dates:
Date Received: September 5, 2013
Date Started: September 2013
Date Completion: September 2014
Last Updated: September 12, 2013
Last Verified: September 2013