The COPENHAGEN Puberty Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Puberty

Age range

5 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Growth and Reproduction, Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Pubertal Onset

Time frame: up to 8 year period.

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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

European Commission
The Ministry of Science, Technology and Innovation, Denmark

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2016
Study completion: 2016
First posted: Aug 8, 2011
Registry last updated: Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed