The COPENHAGEN Puberty Study

Puberty Clinical Trial

Official title:

The COPENHAGEN Puberty Study Providing Normative Data of Healthy Danish Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411527
• Other study ID #: KF01282214
• Status: Completed
• Start date: July 2006
• Est. completion date: December 31, 2016

Study information

• Verified date: September 2019
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1957
• Est. completion date: December 31, 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Puberty

Locations

Country	Name	City	State
Denmark	Department of Growth and Reproduction, Rigshospitalet	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	European Commission, The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (22)

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 J — View Citation

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 — View Citation

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. doi: 10.1542/peds.2008-2491. — View Citation

Almstrup K, Lindhardt Johansen M, Busch AS, Hagen CP, Nielsen JE, Petersen JH, Juul A. Pubertal development in healthy children is mirrored by DNA methylation patterns in peripheral blood. Sci Rep. 2016 Jun 28;6:28657. doi: 10.1038/srep28657. Erratum in: — View Citation

Busch AS, Hagen CP, Almstrup K, Juul A. Circulating MKRN3 Levels Decline During Puberty in Healthy Boys. J Clin Endocrinol Metab. 2016 Jun;101(6):2588-93. doi: 10.1210/jc.2016-1488. Epub 2016 Apr 8. — View Citation

Busch AS, Hagen CP, Main KM, Pereira A, Corvalan C, Almstrup K, Mericq V, Juul A. Genetic Variation of Follicle-Stimulating Hormone Action Is Associated With Age at Testicular Growth in Boys. J Clin Endocrinol Metab. 2017 May 1;102(5):1740-1749. doi: 10.1 — View Citation

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. doi: 10.1210/jc.2009-1140. Epub 2009 Nov 20. — View Citation

Frederiksen H, Aksglaede L, Sorensen K, Nielsen O, Main KM, Skakkebaek NE, Juul A, Andersson AM. Bisphenol A and other phenols in urine from Danish children and adolescents analyzed by isotope diluted TurboFlow-LC-MS/MS. Int J Hyg Environ Health. 2013 Nov — View Citation

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. — View Citation

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 f — View Citation

Hagen CP, Aksglaede L, Sørensen K, Mouritsen A, Andersson AM, Petersen JH, Main KM, Juul A. Individual serum levels of anti-Müllerian hormone in healthy girls persist through childhood and adolescence: a longitudinal cohort study. Hum Reprod. 2012 Mar;27( — View Citation

Hilsted L, Rustad P, Aksglæde L, Sørensen K, Juul A. Recommended Nordic paediatric reference intervals for 21 common biochemical properties. Scand J Clin Lab Invest. 2013 Feb;73(1):1-9. doi: 10.3109/00365513.2012.721519. Epub 2012 Sep 26. Erratum in: Scan — View Citation

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. — View Citation

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: 10.11 — View Citation

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. doi: 10.1210/jc.2010-2745 — View Citation

Mouritsen A, Aksglaede L, Soerensen K, Hagen CP, Petersen JH, Main KM, Juul A. The pubertal transition in 179 healthy Danish children: associations between pubarche, adrenarche, gonadarche, and body composition. Eur J Endocrinol. 2012 Dec 31;168(2):129-36 — View Citation

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 — View Citation

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 — View Citation

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; — View Citation

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. doi: 10.1210/jc.2009-1478. Epub 2009 Nov 19. — View Citation

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. doi: 10.1210/jc.2009-24 — View Citation

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. doi: 10.1210/jc.2010-0731. E — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pubertal Onset	Pubertal onset (according to Tanner stageing - Marshall & Tanner 1969 and 1970), i.e. Tanner stages B2+ or G2+ [Tanner stages included genital stages 1-5 as well as pubic hairs tages 1-6]; Data of both arms were pooled for calculation of means.	up to 8 year period.