Long-term Outcome of GnRH Analogues Treatment of Children With Idiopathic Central Precocious Puberty

NCT02790112 | Unknown DMC

• 2 other identifiers: 2015/14OCT/549RESEARCH GRANT
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the influence of early adiposity rebound, genetic polymorphisms and GnRHa treatment on long-term outcome of girls with idiopathic central precocious puberty.

Conditions

Puberty, Precocious; Adiposity

Keywords

Body Mass Index; Body Composition; Glucose Metabolism Disorders; Bone Development; Gonadal Disorders; Fertility; Overweight; Obesity; Menarche

Outcome Measures

Primary Outcomes (1)

• Single nucleotide polymorphisms (SNP) analyses

  DNA analyses

  1 day

Secondary Outcomes (32)

• Adult height in meters

  1 day

• Body mass index in kg/m2

  1 day

• Body composition in %

  1 day

• Glucose in mg/dl

  1 day

• Total Cholesterol in mg/dl

  1 day

Other Outcomes (1)

• Quality of life

  1 day

Study Arms (3)

GnRHas - Not GnRHas patients

OTHER

Compared long term outcome of treated and untreated patients with idiopathic central precocious puberty : hormonal assessment; DNA for candidate single nucleotide polymorphisms (SNP) analyses; pelvic ultrasound; dual energy x-ray absorptiometry (DXA)

Other: GnRHas

GnRHas - controls patients

OTHER

Compared long term outcome of treated patients with idiopathic central precocious puberty and control patients for: hormonal assessment; DNA for candidate single nucleotide polymorphisms (SNP) analyses; pelvic ultrasound; dual energy x-ray absorptiometry (DXA)

Other: GnRHas

Not GnRHas - Controls patients

OTHER

Compared long term outcome of untreated patients with idiopathic central precocious puberty and control patients for: hormonal assessment; DNA for candidate single nucleotide polymorphisms (SNP) analyses; pelvic ultrasound; dual energy x-ray absorptiometry (DXA)

Other: GnRHas

Interventions

GnRHas OTHER

Influence of early adiposity rebound, genetic polymorphisms and GnRHa treatment on long-term outcome of treated and untreated girls with idiopathic central precocious compared to a control group. puberty.

GnRHas - Not GnRHas patients; GnRHas - controls patients; Not GnRHas - Controls patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of idiopathic CPP (ICPP) treated with GnRHas.
• A diagnosis of CPP made according to the following criteria: 1) secondary pubertal signs (Tanner stage 2) before 8 years in girls and 9 years in boys; 2) accelerated growth velocity (GV); 3) BA advanced for CA ≥ 1 year; 4) GnRH-stimulated peak LH \>5 IU/L.
• A diagnosis of idiopathic CPP according the following criteria: 1) no hypothalamic-pituitary organic lesions at magnetic resonance imaging; 2) no known medical condition that might affect the onset of puberty.
• To determine whether the supposed long-term effects of treatment are instead consequences of the disease itself, untreated ICPP girls aged of ≥ 18 years, will also be included. For comparative purposes, age-matched normal (menarche \> 10 y) volunteers will be recruited as a control group.

You may not qualify if:

• In the treated ICCP group if 1) treatment with GnRHas for \< 2 years; 2) non-compliance; 3) no gonadotropin suppression observed.
• For all patients: 4) small for gestational age; 5) chronic disease and/or treatment; 6) being \< 4 years from menarche.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead
• Belgian Study Group for Pediatric Endocrinology: collaborator

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

Location

Related Publications (23)

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• Carel JC, Eugster EA, Rogol A, Ghizzoni L, Palmert MR; ESPE-LWPES GnRH Analogs Consensus Conference Group; Antoniazzi F, Berenbaum S, Bourguignon JP, Chrousos GP, Coste J, Deal S, de Vries L, Foster C, Heger S, Holland J, Jahnukainen K, Juul A, Kaplowitz P, Lahlou N, Lee MM, Lee P, Merke DP, Neely EK, Oostdijk W, Phillip M, Rosenfield RL, Shulman D, Styne D, Tauber M, Wit JM. Consensus statement on the use of gonadotropin-releasing hormone analogs in children. Pediatrics. 2009 Apr;123(4):e752-62. doi: 10.1542/peds.2008-1783. Epub 2009 Mar 30.

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• Lazar L, Lebenthal Y, Yackobovitch-Gavan M, Shalitin S, de Vries L, Phillip M, Meyerovitch J. Treated and untreated women with idiopathic precocious puberty: BMI evolution, metabolic outcome, and general health between third and fifth decades. J Clin Endocrinol Metab. 2015 Apr;100(4):1445-51. doi: 10.1210/jc.2014-3748. Epub 2015 Feb 4.

  PMID: 25650898 BACKGROUND

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• Franceschi R, Gaudino R, Marcolongo A, Gallo MC, Rossi L, Antoniazzi F, Tato L. Prevalence of polycystic ovary syndrome in young women who had idiopathic central precocious puberty. Fertil Steril. 2010 Mar 1;93(4):1185-91. doi: 10.1016/j.fertnstert.2008.11.016. Epub 2009 Jan 9.

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• Colmenares A, Gunczler P, Lanes R. Higher prevalence of obesity and overweight without an adverse metabolic profile in girls with central precocious puberty compared to girls with early puberty, regardless of GnRH analogue treatment. Int J Pediatr Endocrinol. 2014;2014(1):5. doi: 10.1186/1687-9856-2014-5. Epub 2014 Apr 17.

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MeSH Terms

Conditions

Puberty, Precocious; Obesity; Glucose Metabolism Disorders; Gonadal Disorders; Overweight

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases

Study Officials

• Constanza Navarro Moreno, D

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: June 3, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: October 1, 2018
• Last Updated: June 3, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)