- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04884620
The 3rd COPENHAGEN Puberty Study
The COPENHAGEN School Study. Normal Pubertal Development in Youth 2021 and Long-term Disease and Death Risk After Extremely Early Puberty
Study Overview
Status
Conditions
Detailed Description
Cross-sectional School study:
All children will be examined once and the following data will be collected:
- 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.
- 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
- Spot urine sample (100 ml) for measurement of FSH, LH, testosterone and endocrine disrupters ( parabens, pthalates, bisphenol A, UV-filters and triclosan)
- 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Anders Juul, PhD, DMSc
- Phone Number: +45 35 45 13 77
- Email: anders.juul@regionh.dk
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Recruiting
- Rigshospitalet, Department of Growth and Reproduction
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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)
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Cross-sectional cohort
Healthy children and adolescents from twenty-five selected schools in the metropolitan area
|
Longitudinal cohort
Cases 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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pubertal development
Time Frame: Up to an 8 year period
|
Pubertal onset according to Tanner criteria:
|
Up to an 8 year period
|
Long-term disease and death risk after extremely early puberty
Time Frame: Up to a 20 year period
|
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.
|
Up to a 20 year period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anders Juul, PhD, DMSc, Rigshospitalet, Department of Growth and Reproduction
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CopenhagenPuberty3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Puberty, Precocious
-
AbbVieCompletedCentral Precocious Puberty (CPP)United States, Puerto Rico
-
Debiopharm International SARecruiting
-
Foresee Pharmaceuticals Co., Ltd.QPS Holdings LLC; Changchun GeneScience Pharmaceutical Co., Ltd.RecruitingPuberty; Precocious, CentralUnited States, China, Taiwan, Puerto Rico
-
IpsenCompleted
-
TakedaCompletedCentral Precocious PubertyChina
-
TakedaCompletedCentral Precocious PubertyChina
-
Debiopharm International SACompletedCentral Precocious PubertyUnited States, Chile, Mexico
-
Ruijin HospitalShanghai Children's Hospital; Shanghai Children's Medical Center; Xin Hua HospitalCompletedCentral Precocious Puberty
-
Daewoong Pharmaceutical Co. LTD.CompletedCentral Precocious PubertyKorea, Republic of
-
University of PisaUnknownCentral Precocious PubertyItaly