Investigating puberty onset in Danish children
The COPENHAGEN School Study. Normal Pubertal Development in Youth 2021 and Long-term Disease and Death Risk After Extremely Early Puberty
This study looks at healthy Danish school children to see if they are starting puberty earlier than they did 15 years ago and what that might mean for their long-term health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 5 Years to 19 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT04884620 on ClinicalTrials.gov |
What this trial studies
This observational study examines healthy Danish school children to determine if the age of pubertal onset has continued to decline over the past 15 years. It involves clinical examinations and blood sample withdrawals to assess various physical development markers and hormone levels. The study aims to explore the mechanisms behind earlier puberty onset and the long-term health risks associated with extremely early puberty using data from Danish registries.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy children and adolescents of Caucasian descent.
Not a fit: Patients with acute diseases, cancer, or chronic conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the health implications of early puberty and inform public health strategies.
How similar studies have performed: Other studies have shown varying results regarding the trends in puberty onset, but this specific approach is novel in its comprehensive assessment of both physical and hormonal factors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy children and adolescents Exclusion Criteria: * 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
Where this trial is running
Copenhagen
- Rigshospitalet, Department of Growth and Reproduction — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Anders Juul, PhD, DMSc — Rigshospitalet, Department of Growth and Reproduction
- Study coordinator: Anders Juul, PhD, DMSc
- Email: anders.juul@regionh.dk
- Phone: +45 35 45 13 77
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.