Long-term Outcome of GnRH Analogues Treatment of Children With Idiopathic Central Precocious Puberty
NCT ID: NCT02790112
Last Updated: 2016-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
418 participants
INTERVENTIONAL
2016-04-30
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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GnRHas - Not GnRHas patients
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)
GnRHas
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 - controls patients
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)
GnRHas
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.
Not GnRHas - Controls patients
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)
GnRHas
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.
Interventions
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GnRHas
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* For all patients: 4) small for gestational age; 5) chronic disease and/or treatment; 6) being \< 4 years from menarche.
18 Years
ALL
Yes
Sponsors
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Belgian Study Group for Pediatric Endocrinology
OTHER
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Responsible Party
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Principal Investigators
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Constanza Navarro Moreno, D
Role: PRINCIPAL_INVESTIGATOR
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Locations
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Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium
Countries
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References
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Lee JM, Appugliese D, Kaciroti N, Corwyn RF, Bradley RH, Lumeng JC. Weight status in young girls and the onset of puberty. Pediatrics. 2007 Mar;119(3):e624-30. doi: 10.1542/peds.2006-2188.
Lakshman R, Forouhi NG, Sharp SJ, Luben R, Bingham SA, Khaw KT, Wareham NJ, Ong KK. Early age at menarche associated with cardiovascular disease and mortality. J Clin Endocrinol Metab. 2009 Dec;94(12):4953-60. doi: 10.1210/jc.2009-1789. Epub 2009 Oct 30.
Parent AS, Franssen D, Fudvoye J, Pinson A, Bourguignon JP. Current Changes in Pubertal Timing: Revised Vision in Relation with Environmental Factors Including Endocrine Disruptors. Endocr Dev. 2016;29:174-84. doi: 10.1159/000438885. Epub 2015 Dec 17.
Sorensen K, Mouritsen A, Aksglaede L, Hagen CP, Mogensen SS, Juul A. Recent secular trends in pubertal timing: implications for evaluation and diagnosis of precocious puberty. Horm Res Paediatr. 2012;77(3):137-45. doi: 10.1159/000336325. Epub 2012 Apr 12.
Copeland W, Shanahan L, Miller S, Costello EJ, Angold A, Maughan B. Outcomes of early pubertal timing in young women: a prospective population-based study. Am J Psychiatry. 2010 Oct;167(10):1218-25. doi: 10.1176/appi.ajp.2010.09081190. Epub 2010 May 17.
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.
Klein KO, Barnes KM, Jones JV, Feuillan PP, Cutler GB Jr. Increased final height in precocious puberty after long-term treatment with LHRH agonists: the National Institutes of Health experience. J Clin Endocrinol Metab. 2001 Oct;86(10):4711-6. doi: 10.1210/jcem.86.10.7915.
Brito VN, Latronico AC, Cukier P, Teles MG, Silveira LF, Arnhold IJ, Mendonca BB. Factors determining normal adult height in girls with gonadotropin-dependent precocious puberty treated with depot gonadotropin-releasing hormone analogs. J Clin Endocrinol Metab. 2008 Jul;93(7):2662-9. doi: 10.1210/jc.2007-2183. Epub 2008 May 6.
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.
Magiakou MA, Manousaki D, Papadaki M, Hadjidakis D, Levidou G, Vakaki M, Papaefstathiou A, Lalioti N, Kanaka-Gantenbein C, Piaditis G, Chrousos GP, Dacou-Voutetakis C. The efficacy and safety of gonadotropin-releasing hormone analog treatment in childhood and adolescence: a single center, long-term follow-up study. J Clin Endocrinol Metab. 2010 Jan;95(1):109-17. doi: 10.1210/jc.2009-0793. Epub 2009 Nov 6.
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.
Barker DJ, Osmond C, Forsen TJ, Kajantie E, Eriksson JG. Trajectories of growth among children who have coronary events as adults. N Engl J Med. 2005 Oct 27;353(17):1802-9. doi: 10.1056/NEJMoa044160.
Brockenbrough JS, Meyer SA, Li CX, Jirtle RL. Reversible and phorbol ester-specific defect of protein kinase C translocation in hepatocytes isolated from phenobarbital-treated rats. Cancer Res. 1991 Jan 1;51(1):130-6.
Canoy D, Beral V, Balkwill A, Wright FL, Kroll ME, Reeves GK, Green J, Cairns BJ; Million Women Study Collaborators*. Age at menarche and risks of coronary heart and other vascular diseases in a large UK cohort. Circulation. 2015 Jan 20;131(3):237-44. doi: 10.1161/CIRCULATIONAHA.114.010070. Epub 2014 Dec 15.
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.
Ibanez L, Lopez-Bermejo A, Diaz M, Suarez L, de Zegher F. Low-birth weight children develop lower sex hormone binding globulin and higher dehydroepiandrosterone sulfate levels and aggravate their visceral adiposity and hypoadiponectinemia between six and eight years of age. J Clin Endocrinol Metab. 2009 Oct;94(10):3696-9. doi: 10.1210/jc.2009-0789. Epub 2009 Sep 8.
Dreyfus J, Jacobs DR Jr, Mueller N, Schreiner PJ, Moran A, Carnethon MR, Demerath EW. Age at Menarche and Cardiometabolic Risk in Adulthood: The Coronary Artery Risk Development in Young Adults Study. J Pediatr. 2015 Aug;167(2):344-52.e1. doi: 10.1016/j.jpeds.2015.04.032. Epub 2015 May 9.
Clark EM, Ness AR, Tobias JH. Adipose tissue stimulates bone growth in prepubertal children. J Clin Endocrinol Metab. 2006 Jul;91(7):2534-41. doi: 10.1210/jc.2006-0332. Epub 2006 Apr 18.
Yanovski JA, Rose SR, Municchi G, Pescovitz OH, Hill SC, Cassorla FG, Cutler GB Jr. Treatment with a luteinizing hormone-releasing hormone agonist in adolescents with short stature. N Engl J Med. 2003 Mar 6;348(10):908-17. doi: 10.1056/NEJMoa013555.
Chiavaroli V, Liberati M, D'Antonio F, Masuccio F, Capanna R, Verrotti A, Chiarelli F, Mohn A. GNRH analog therapy in girls with early puberty is associated with the achievement of predicted final height but also with increased risk of polycystic ovary syndrome. Eur J Endocrinol. 2010 Jul;163(1):55-62. doi: 10.1530/EJE-09-1102. Epub 2010 Mar 31.
Ong KK, Elks CE, Wills AK, Wong A, Wareham NJ, Loos RJ, Kuh D, Hardy R. Associations between the pubertal timing-related variant in LIN28B and BMI vary across the life course. J Clin Endocrinol Metab. 2011 Jan;96(1):E125-9. doi: 10.1210/jc.2010-0941. Epub 2010 Oct 20.
Conway G, Dewailly D, Diamanti-Kandarakis E, Escobar-Morreale HF, Franks S, Gambineri A, Kelestimur F, Macut D, Micic D, Pasquali R, Pfeifer M, Pignatelli D, Pugeat M, Yildiz BO; ESE PCOS Special Interest Group. The polycystic ovary syndrome: a position statement from the European Society of Endocrinology. Eur J Endocrinol. 2014 Oct;171(4):P1-29. doi: 10.1530/EJE-14-0253. Epub 2014 May 21.
Deb S, Campbell BK, Pincott-Allen C, Clewes JS, Cumberpatch G, Raine-Fenning NJ. Quantifying effect of combined oral contraceptive pill on functional ovarian reserve as measured by serum anti-Mullerian hormone and small antral follicle count using three-dimensional ultrasound. Ultrasound Obstet Gynecol. 2012 May;39(5):574-80. doi: 10.1002/uog.10114.
Other Identifiers
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RESEARCH GRANT
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2015/14OCT/549
Identifier Type: -
Identifier Source: org_study_id
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