Actively Recruiting

Age: 5Years - 19Years
All Genders
Healthy Volunteers
ID04884620

The COPENHAGEN School Study Normal Pubertal Development in Youth 2021 and Long-term Disease and Death Risk After Extremely Early Puberty

Led by Rigshospitalet, Denmark · Updated on 2024-01-10

3000

Participants Needed

1

Research Sites

1565 weeks

Total Duration

On this page

Sponsors

R

Rigshospitalet, Denmark

Lead Sponsor

E

Environmental Protection Agency (EPA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying healthy Danish school children to investigate whether the age at which puberty starts has continued to decline over the past 15 years. The study also aims to understand the causes of earlier puberty onset and examine the long-term health risks linked to extremely early puberty using national registry data. This combined cross-sectional and longitudinal study includes children aged 5 to 19 years. In the cross-sectional part, children will be examined once through clinical assessments that include height, weight, body fat, blood pressure, and puberty stage evaluations based on Tanner criteria. Blood and urine samples will be collected to measure various hormones, growth factors, endocrine disruptors, and genetic material. Additionally, children will complete electronic questionnaires about their growth, health, lifestyle, and family puberty history. The biological samples will be temporarily stored until July 2026, after which unused samples will be stored long term in a biobank. The longitudinal part of the study will use registry data to follow children diagnosed with extremely early puberty and matched controls over up to 20 years. Researchers will analyze the risk of disease and death in these groups, adjusting for factors like maternal health and birth measurements. During the study, participants will undergo clinical exams, sample collection, and complete questionnaires. The main outcomes measured are pubertal development over eight years and long-term health risks after early puberty.

CONDITIONS

Brief Title

The 3rd COPENHAGEN Puberty Study

Who Can Participate

Age: 5Years - 19Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy children and adolescents
  • Aged between 5 and 19 years
  • Caucasian ethnicity
Not Eligible

You will not qualify if you...

  • Acute disease
  • History of malignant disease or cancer therapy such as chemotherapy or radiation
  • Chronic diseases including cystic fibrosis, juvenile rheumatoid arthritis, systemic lupus erythematosus, sickle cell disease, thalassemia, chronic renal disease
  • Known numerical chromosome aberration
  • Non-Caucasian ethnicity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Cross-sectional Examination

Duration - 1 day

Participants undergo a one-time clinical medical examination and sample collection to assess pubertal development and various biological markers.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 20 years

Participants are followed over many years via registry-based data to assess long-term disease and death risk after extremely early puberty.

No in-person visits; data collected through national registries

Trial Site Locations

Total: 1 location

1

Rigshospitalet, Department of Growth and Reproduction

Copenhagen, Denmark, 2100

Actively Recruiting

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Research Team

A

Anders Juul, PhD, DMSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial