The COPENHAGEN Puberty Study Providing Normative Data of Healthy Danish Children and Adolescents - Full Text View

Purpose

By clinical examinations and withdrawing of blood samples from a large number of healthy Danish children, this study will reveal if age of pubertal onset is declining. Furthermore, the extensive normative data will provide detailed insight into normal ranges and individual changes of anthropometrics and hormone levels in healthy children during childhood and adolescence.

Condition
Puberty

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	The COPENHAGEN Puberty Study

Resource links provided by NLM:

MedlinePlus related topics: Puberty

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Pubertal onset [ Time Frame: The pubertal stage and age were recorded in each participating individual in the cross sectional study from January 2006 to January 2009. Probit analysis was used to determine the age of pubertal onset in boys and girls. ] [ Designated as safety issue: No ]
Female age at pubertal onset was 9.86 years. Male age at pubertal onset was 11.66 years

Biospecimen Retention: Samples With DNA

serum, white cells, urine

Enrollment:	2020
Study Start Date:	January 2006
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
Cross- sectional cohort Schools were randomly selected and 6203 children (50.0 % girls) were invited to participate. 1864 (1097 girls and 767 boys) (age 5.6-20.0 years) were included, resulting in an overall participation-rate of 30%. Blood samples were drawn, and a thorough clinical examination was performed in all participating children
Longitudinal cohort 209 healthy Danish children (108 girls), were examined and blood samples were drawn every 6 months. In july 2011, the mean (range) number of examinations per child was 7 (2-10). 116 (63 boys and 53 girls) continued from the cross sectional study to the longitudinal study. Thus, the total number of participants in The COPENHAGEN Puberty Study was 2020 children.

Detailed Description:

The COPENHAGEN Puberty Study is a combined cross sectional and longitudinal study of healthy Danish children.

All children will be thoroughly examined and blood- and urine samples will be collected at every visit. The families fill out questionaires.

Physical examination: Height; sitting-height; weight; circumference of waist, hip, arm; measurement of fatfolds (biceps, triceps, flank, subscapularis); voice-break (yes/no), blood pressure; pubertal staging according to Tanners classification: breast development (B1-B5), genitalia development boys (G1-G5), pubic hair development (PH1-PH5), axillary hair (yes/no), sweat (yes/no), acne (yes/no

Urine sample: For measurement of FSH, LH and endocrine disrupters.

Blood sample: For measurement of hormone levels (FSH, LH, estradiol, SHBG, testosterone, DHEAS, androstenedione, inhibin A, inhibin B, Insl3, kisspeptin, ghrelin, leptin, IGF-1, IGFBP3, TSH, T4, Free T4, T3, HbA1C, calcium-ion, PTH, phosphate, 25-OH-vitamine D, AMH), endocrine disrupters (PCB´s, dioxines, parabens, phthalates), isolation of DNA and RNA to evaluate relevant polymorphisms.

Questionaire: regarding information of previous growth and health.

Eligibility

Ages Eligible for Study:	5 Years to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

In the cross sectional study, all children at randomly selected schools in Copenhagen were invited (6203 children). 1864 accepted to participate.

In the longitudinal study, children at two schools with the highest participating rate were invited to participate in the follow-up study. Ongoing recruitment was continued until at least 100 boys and 100 girls were enrolled in the logitudinal study.

Criteria

Inclusion Criteria:

all children accepting to participate were included

Exclusion Criteria:

no children were excluded from examination or blood sampling. In case of chronic diseases, medical treatment, or ethnicity the children may be excluded from specific final data analysis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411527

Locations

Denmark
Department of Growth and Reproduction, Rigshospitalet
Copenhagen, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

The Ministry of Science, Technology and Innovation, Denmark

European Commission

Investigators

Study Director:

Anders Juul, PhD, DMSc

Rigshospitalet, dept. of Growth and Reproduction

More Information

Additional Information:

Brief description of the study setup This link exits the ClinicalTrials.gov site

Publications:

Aksglaede L, Sørensen K, Petersen JH, Skakkebaek NE, Juul A. Recent decline in age at breast development: the Copenhagen Puberty Study. Pediatrics. 2009 May;123(5):e932-9.

Sørensen K, Aksglaede L, Petersen JH, Juul A. Recent changes in pubertal timing in healthy Danish boys: associations with body mass index. J Clin Endocrinol Metab. 2010 Jan;95(1):263-70. Epub 2009 Nov 19.

Sørensen K, Aksglaede L, Munch-Andersen T, Aachmann-Andersen NJ, Petersen JH, Hilsted L, Helge JW, Juul A. Sex hormone-binding globulin levels predict insulin sensitivity, disposition index, and cardiovascular risk during puberty. Diabetes Care. 2009 May;32(5):909-14. Epub 2009 Feb 5.

Juul A, Sørensen K, Aksglaede L, Garn I, Rajpert-De Meyts E, Hullstein I, Hemmersbach P, Ottesen AM. A common deletion in the uridine diphosphate glucuronyltransferase (UGT) 2B17 gene is a strong determinant of androgen excretion in healthy pubertal boys. J Clin Endocrinol Metab. 2009 Mar;94(3):1005-11. Epub 2008 Dec 16.

Sørensen K, Aksglaede L, Munch-Andersen T, Aachmann-Andersen NJ, Leffers H, Helge JW, Hilsted L, Juul A. Impact of the growth hormone receptor exon 3 deletion gene polymorphism on glucose metabolism, lipids, and insulin-like growth factor-I levels during puberty. J Clin Endocrinol Metab. 2009 Aug;94(8):2966-9. Epub 2009 May 5.

Courant F, Aksglaede L, Antignac JP, Monteau F, Sorensen K, Andersson AM, Skakkebaek NE, Juul A, Bizec BL. Assessment of circulating sex steroid levels in prepubertal and pubertal boys and girls by a novel ultrasensitive gas chromatography-tandem mass spectrometry method. J Clin Endocrinol Metab. 2010 Jan;95(1):82-92. Epub 2009 Nov 20.

Sørensen K, Aksglaede L, Petersen JH, Leffers H, Juul A. The exon 3 deleted growth hormone receptor gene is associated with small birth size and early pubertal onset in healthy boys. J Clin Endocrinol Metab. 2010 Jun;95(6):2819-26. Epub 2010 Apr 9.

Sørensen K, Mouritsen A, Mogensen SS, Aksglaede L, Juul A. Insulin sensitivity and lipid profiles in girls with central precocious puberty before and during gonadal suppression. J Clin Endocrinol Metab. 2010 Aug;95(8):3736-44. Epub 2010 May 19.

Hagen CP, Aksglaede L, Sørensen K, Main KM, Boas M, Cleemann L, Holm K, Gravholt CH, Andersson AM, Pedersen AT, Petersen JH, Linneberg A, Kjaergaard S, Juul A. Serum levels of anti-Müllerian hormone as a marker of ovarian function in 926 healthy females from birth to adulthood and in 172 Turner syndrome patients. J Clin Endocrinol Metab. 2010 Nov;95(11):5003-10. Epub 2010 Aug 18.

Aksglaede L, Sørensen K, Boas M, Mouritsen A, Hagen CP, Jensen RB, Petersen JH, Linneberg A, Andersson AM, Main KM, Skakkebæk NE, Juul A. Changes in anti-Müllerian hormone (AMH) throughout the life span: a population-based study of 1027 healthy males from birth (cord blood) to the age of 69 years. J Clin Endocrinol Metab. 2010 Dec;95(12):5357-64. Epub 2010 Sep 15.

Mogensen SS, Aksglaede L, Mouritsen A, Sørensen K, Main KM, Gideon P, Juul A. Diagnostic work-up of 449 consecutive girls who were referred to be evaluated for precocious puberty. J Clin Endocrinol Metab. 2011 May;96(5):1393-401. Epub 2011 Feb 23.

Aksglaede L, Christiansen P, Sørensen K, Boas M, Linneberg A, Main KM, Andersson AM, Skakkebaek NE, Juul A. Serum concentrations of Anti-Müllerian Hormone (AMH) in 95 patients with Klinefelter syndrome with or without cryptorchidism. Acta Paediatr. 2011 Jun;100(6):839-45. Epub 2011 Feb 25.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mouritsen A, Hagen CP, Sørensen K, Aksglaede L, Mieritz MG, Main KM, Almstrup K, Rajpert-De Meyts E, Juul A. Androgen receptor CAG repeat length is associated with body fat and serum SHBG in boys: a prospective cohort study. J Clin Endocrinol Metab. 2013 Mar;98(3):E605-9. doi: 10.1210/jc.2012-3778. Epub 2013 Feb 7.

Hagen CP, Sørensen K, Anderson RA, Juul A. Serum levels of antimüllerian hormone in early maturing girls before, during, and after suppression with GnRH agonist. Fertil Steril. 2012 Nov;98(5):1326-30. doi: 10.1016/j.fertnstert.2012.07.1118. Epub 2012 Aug 14.

Mieritz MG, Frederiksen H, Sørensen K, Aksglaede L, Mouritsen A, Hagen CP, Skakkebaek NE, Andersson AM, Juul A. Urinary phthalate excretion in 555 healthy Danish boys with and without pubertal gynaecomastia. Int J Androl. 2012 Jun;35(3):227-35. doi: 10.1111/j.1365-2605.2012.01279.x.

Frederiksen H, Sørensen K, Mouritsen A, Aksglaede L, Hagen CP, Petersen JH, Skakkebaek NE, Andersson AM, Juul A. High urinary phthalate concentration associated with delayed pubarche in girls. Int J Androl. 2012 Jun;35(3):216-26. doi: 10.1111/j.1365-2605.2012.01260.x. Epub 2012 Mar 19.

Responsible Party:	Anders Juul, Department of Growth and Reproduction, Rigshospitalet
ClinicalTrials.gov Identifier:	NCT01411527 History of Changes
Other Study ID Numbers:	KF01282214
Study First Received:	August 3, 2011
Last Updated:	August 9, 2011
Health Authority:	Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:

Hormones
Endocrine Disrupters
Polymorphism, Genetic

ClinicalTrials.gov processed this record on May 22, 2013