The 3rd COPENHAGEN Puberty Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-19
SponsorRigshospitalet, Denmark
About this trial
The COPENHAGEN School Study is a combined cross-sectional and longitudinal study of healthy Danish school children. This study will by clinical examinations and withdrawal of blood samples investigate whether age of pubertal onset is continuing to decline in Denmark over the past 15 years. Furthermore, we will investigate the mechanism driving earlier onset of puberty and the long term health risks of extremely early puberty using Danish registry data
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy children and adolescents
Disqualifiers
In case of acute disease, cancer, cancer therapy, or chronic disease (History of malignant disease, chemotherapy or radiation, cystic fibrosis, juvenile rheumatoid arthritis, systemic lupus erythematosus, sickle cell disease, thalassemia, chronic renal disease or known numerical chromosome aberration)
Non-Caucasian
Trial population
Cross-sectional population-based puberty study: All children and adolescents from 25 selected schools in the metropolitan area were invited to participate in the study Longitudinal register-based follow up study of children with precocious puberty: All hospital patient records of first-time diagnoses of extremely early puberty within the period 1995-2019 was identified (N=8596) in the National Patient Registry. Five randomly selected persons matched on age and sex for each case of extremely early puberty diagnosis were drawn from the general background population in the Danish Civil registry (CPR) (n=42,980)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
3,000 Participants
are grouped into 2 trial groupsGroup A: Cross-sectional cohort
Group B: Longitudinal cohort
Trial outcomes
Primary outcomes
1
Pubertal development
Pubertal onset according to Tanner criteria: * Girls was investigated for assessment of breast development stage B1-5 (by palpation), pubic hair staging PH1-5, occurrence of axillary hair (Stage 0-2), menarche, sweat and acne. * Boys was examined in order to assess their genitalia development stage G1-5, pubic hair stage PH1-6, occurrence of axillary hair, acne, sweat, voice break and testicular volume (Praders orchidometer30).
Time frame
Up to an 8 year period2
Long-term disease and death risk after extremely early puberty
Diagnoses include cancer (prostate and breast), metabolic syndrome, diabetes type 2, cardiovascular disorders (coronary heart disease, heart failure, stroke), and mental health outcomes (depression (major or chronic), anxiety, attempted suicide). Information on the outcomes of interest were extracted from national registers including the National Patient Register, Psychiatric Central Research Registry, National Prescription Registry, Cancer Registry, Causes of Death Registry40 and Medical Birth Registry.
Time frame
Up to a 20 year periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Environmental Protection Agency (EPA)
Collaborator
European Commission
Collaborator
Source ClinicalTrials.gov