The COPENHAGEN Puberty Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Puberty

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cross- sectional cohort<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hormones, Endocrine Disrupters, Polymorphism, Genetic