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PubertyNCT04884620

The 3rd COPENHAGEN Puberty Study

An observational study of Puberty and Puberty, Precocious, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 5 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Puberty, Puberty, Precocious
How many people
3,000 participants
Where
1 siteDenmark
Study dates
1 Jan 2023to 31 Dec 2056
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study 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)

Who may be able to join

  • Healthy children and adolescents

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anders Juul, PhD, DMSc contact

+45 35 45 13 77

anders.juul@regionh.dk

Denmark1 site, 1 recruiting

  • Rigshospitalet, Department of Growth and Reproduction

    Copenhagen, 2100

    Recruiting

Other trials in Denmark

About this study

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

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

Read the detailed description

Cross-sectional School study:

All children will be examined once and the following data will be collected:

  1. Clinical medical examination of the child consisting of height measurements (standing- and sitting-height), arm-span, weight, fat fold measurements (biceps, triceps, flank, subscapularis), circumference of waist and hip, waist-hip ratio, blood pressure, body fat composition. Puberty development will be assessed by trained and experienced clinical personal according to Tanner criteria. Girls will be investigated for assessment of breast development stage B1-5 (by palpation), pubic hair staging PH1-5, occurrence of axillary hair (Stage 0-2), menarche (yes / no), sweat (yes/no) and acne (yes/no), and boys, their genitalia development stage G1-5, pubic hair stage PH1-6, occurrence of axillary hair (yes/no), acne (yes/no), sweat (yes/no), voice frequency, and voice break (yes/no). The testicular volume assessed by means of Praders orchidometer.
  2. Blood sample (35 ml) for measurement of: a) Hormone levels, peptides and growth factors (FSH, LH, estradiol (total/free), progesterone, estrone/estrone sulphate, SHBG, testosterone (total/free), DHEAS, 17-hydroxyprogestrerone, androstenedione, 11-dinhibin B, AMH, INSL3 (only boys), kisspeptin, ghrelin, leptin, IGF-1, IGFBP-3, IGF-related peptides, eoxycortisol, cortisol, cortisone, RANKL, OPG, fibroblast growth factor 23 (FGF23), TSH, T4, free T4, T3, free T3, HbA1C, calcium ion, alkaline phosphatase, PTH, magnesium, phosphate, 25-OH-vitamin D, osteocalcin, prolactin, insulin and lipids (HDL, LDL, TG, Ip(a), cholesterol and lipoproteins), blood metabolites (e.g. amino acids, biogenic amines, acylcarnitines, lyso-phosphatidylcholines, phosphatidylcholines, sphingomyelins and hexose) and proteins (e.g. cytokines, growth factors, kinases, plasma receptors, proteases, protease inhibitors, plasma hormones and structural proteins)); b) Endocrine disrupters (PCBs, dioxins, parabens and phtalates); and c) DNA and RNA
  3. Spot urine sample (100 ml) for measurement of FSH, LH, testosterone and endocrine disrupters ( parabens, pthalates, bisphenol A, UV-filters and triclosan)
  4. Self-administered electronic questionnaire collecting information on previous growth, illness, living conditions, lifestyle factors, parents' puberty history and current hight and weight.

Biobank Blood and urine samples will be temporary stored during the data collection period until 30th of July 2026. After this date, all unused serum, urine and DNA/RNA not used in the planned analyses will be stored at the established permanent (RegionH, Fælles Fryserfaciliteter) biobank (BIOSEK). The period of storage here is 30 years from the date that the temporary storage is closed.

Prospective Registry-based Cohort study of the Long-term health and death risk after extremely early puberty:

With a follow-up design, we will assess risk of morbidity and mortality amongst cases and referent children. Hazard rations (HRs) will be calculated using Cox regression analyses with stratification using each case and his/her matched referent subjects as a stratum. This ensures that comparisons are adjusted for age and calendar time. Co-variates includes maternal (BMI, smoking, socioeconomic status) during the index pregnancy, also birth weight, length and head circumference of participants. All will be identified in national registries for all persons.

Medical subject headings
Puberty, Precocious

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04884620
Study groupRoleWhat they receive
Cross-sectional cohortHealthy children and adolescents from twenty-five selected schools in the metropolitan area
Longitudinal cohortCases with first-time diagnoses of extremely early puberty within the period 1995-2019 in the National Patient Registry and five randomly selected references drawn from the general background population in the Danish Civil registry (CPR) matched on age and sex for each case

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to an 8 year period

  2. 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.

    Measured: Up to a 20 year period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2021
  2. Study start1 Jan 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2056 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04884620
Sponsor's protocol ID
CopenhagenPuberty3
Status last verified
Jan 2024
First submitted
7 May 2021
Last updated
10 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Edstrom PB, Holmboe SA, Vilmann L, Grondahl VLR, Fritzboger AFO, Thomsen CE, Frederiksen H, Schroder M, Jorgensen NR, Hagen CP, Aksglaede L, Ljubicic ML, Petersen JH, Juul A, Johannsen TH. ACTH and renin in 529 healthy youths: associations to sex, puberty and contraceptives. Endocr Connect. 2026 Mar 5;15(3):e250541. doi: 10.1530/EC-25-0541. Print 2026 Mar 1.

    PubMed 41693548

Questions about this trial

What is this clinical trial studying?

An observational study of Puberty and Puberty, Precocious, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anders Juul, PhD, DMSc (+45 35 45 13 77, anders.juul@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pubertal development (time frame: Up to an 8 year period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04884620, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.

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