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

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ClinicalTrials.gov Identifier: NCT01411527
Recruitment Status : Unknown
Verified December 2013 by Anders Juul, Rigshospitalet, Denmark.
Recruitment status was:  Active, not recruiting
First Posted : August 8, 2011
Last Update Posted : December 9, 2013
The Ministry of Science, Technology and Innovation, Denmark
European Commission
Information provided by (Responsible Party):
Anders Juul, Rigshospitalet, Denmark

Brief 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.

Condition or disease

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.

Study Type : Observational
Actual Enrollment : 2020 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The COPENHAGEN Puberty Study
Study Start Date : January 2006
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Puberty
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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. ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411527

Department of Growth and Reproduction, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
The Ministry of Science, Technology and Innovation, Denmark
European Commission
Study Director: Anders Juul, PhD, DMSc Rigshospitalet, dept. of Growth and Reproduction


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anders Juul, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01411527     History of Changes
Other Study ID Numbers: KF01282214
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: December 2013

Keywords provided by Anders Juul, Rigshospitalet, Denmark:
Endocrine Disrupters
Polymorphism, Genetic