Puberty Clinical Trial
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
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | December 31, 2056 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 19 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet, Department of Growth and Reproduction | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Environmental Protection Agency (EPA), European Commission |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). |
Up to an 8 year period | |
Primary | 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. | Up to a 20 year period |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05008276 -
Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
|
||
Recruiting |
NCT04203381 -
Skeletal Health and Bone Marrow Composition Among Youth
|
N/A | |
Enrolling by invitation |
NCT05463120 -
Minipuberty of Infancy and the Timing of Pubertal Development in Adolescence: a Follow-up of the Infant Feeding and Early Development (IFED) Cohort
|
||
Recruiting |
NCT04723862 -
Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?
|
Early Phase 1 | |
Suspended |
NCT02611128 -
Urinary DENND1A.V2 as a Predictor of Pubertal Hyperandrogenemia
|
||
Completed |
NCT01517139 -
Diet and Nutrition Pilot Study for Chinese Adolescents and Their Mothers
|
||
Not yet recruiting |
NCT06237387 -
Association of Acne Vulgaris With Oral Hygiene and Gingivitis
|
||
Recruiting |
NCT00929006 -
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
|
Early Phase 1 | |
Recruiting |
NCT03068910 -
Hyperandrogenemia and Altered Day-night LH Pulse Patterns
|
Early Phase 1 | |
Completed |
NCT01411527 -
The COPENHAGEN Puberty Study
|
||
Recruiting |
NCT02155933 -
Assessment of Day-night Secretion of Progesterone and LH Across Puberty
|
||
Recruiting |
NCT04424576 -
Ovarian Morphology in Girls
|
||
Recruiting |
NCT02583646 -
Investigating the Impact of Obesity on Pubertal Development in Girls
|