The COPENHAGEN Puberty Study
Study Details
Study Description
Brief Summary
By clinical examinations and withdrawing of blood samples from a large number of healthy Danish children, this study will reveal if age of pubertal onset is declining. Furthermore, the extensive normative data will provide detailed insight into normal ranges and individual changes of anthropometrics and hormone levels in healthy children during childhood and adolescence.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
The COPENHAGEN Puberty Study is a combined cross sectional and longitudinal study of healthy Danish children.
All children will be thoroughly examined and blood- and urine samples will be collected at every visit. The families fill out questionaires.
Physical examination: Height; sitting-height; weight; circumference of waist, hip, arm; measurement of fatfolds (biceps, triceps, flank, subscapularis); voice-break (yes/no), blood pressure; pubertal staging according to Tanners classification: breast development (B1-B5), genitalia development boys (G1-G5), pubic hair development (PH1-PH5), axillary hair (yes/no), sweat (yes/no), acne (yes/no
Urine sample: For measurement of FSH, LH and endocrine disrupters.
Blood sample: For measurement of hormone levels (FSH, LH, estradiol, SHBG, testosterone, DHEAS, androstenedione, inhibin A, inhibin B, Insl3, kisspeptin, ghrelin, leptin, IGF-1, IGFBP3, TSH, T4, Free T4, T3, HbA1C, calcium-ion, PTH, phosphate, 25-OH-vitamine D, AMH), endocrine disrupters (PCB´s, dioxines, parabens, phthalates), isolation of DNA and RNA to evaluate relevant polymorphisms.
Questionaire: regarding information of previous growth and health.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cross- sectional cohort Schools were randomly selected and 6203 children (50.0 % girls) were invited to participate. 1864 (1097 girls and 767 boys) (age 5.6-20.0 years) were included, resulting in an overall participation-rate of 30%. Blood samples were drawn, and a thorough clinical examination was performed in all participating children |
|
| Longitudinal cohort 209 healthy Danish children (108 girls), were examined and blood samples were drawn every 6 months. In july 2011, the mean (range) number of examinations per child was 7 (2-10). 116 (63 boys and 53 girls) continued from the cross sectional study to the longitudinal study. Thus, the total number of participants in The COPENHAGEN Puberty Study was 2020 children. |
Outcome Measures
Primary Outcome Measures
- Pubertal Onset [up to 8 year period.]
Pubertal onset (according to Tanner stageing - Marshall & Tanner 1969 and 1970), i.e. Tanner stages B2+ or G2+ [Tanner stages included genital stages 1-5 as well as pubic hairs tages 1-6] Data of both arms were pooled for calculation of means.
Eligibility Criteria
Criteria
Inclusion Criteria:
- all children accepting to participate were included
Exclusion Criteria:
- no children were excluded from examination or blood sampling. In case of chronic diseases, medical treatment, or ethnicity the children may be excluded from specific final data analysis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Growth and Reproduction, Rigshospitalet | Copenhagen | Denmark | 2100 |
Sponsors and Collaborators
- Rigshospitalet, Denmark
- The Ministry of Science, Technology and Innovation, Denmark
- European Commission
Investigators
- Study Director: Anders Juul, PhD, DMSc, Rigshospitalet, dept. of Growth and Reproduction
Study Documents (Full-Text)
None provided.More Information
Publications
- KF01282214
Study Results
Participant Flow
| Recruitment Details | Cross-sectional study: All pupils at 10 different schools in the Copenhagen area were invited to participate. Longitudinal study: All pupils from 2 of the 10 schools were invited to participate in the follow up study. This includes pupils that have been recruited to the cross-sectional part. (see footnote) |
|---|---|
| Pre-assignment Detail | No participants were excluded |
| Arm/Group Title | Cross- Sectional Cohort | Longitudinal Cohort |
|---|---|---|
| Arm/Group Description | Schools were randomly selected. Blood samples were drawn, and a thorough clinical examination was performed in all participating children | Healthy Danish children were examined and blood samples were drawn every 6 months. |
| Period Title: Overall Study | ||
| STARTED | 1864 | 93 |
| COMPLETED | 1864 | 93 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Cross- Sectional Cohort | Longitudinal Cohort | Total |
|---|---|---|---|
| Arm/Group Description | Schools were randomly selected and 6203 children (50.0 % girls) were invited to participate. 1864 (1097 girls and 767 boys) (age 5.6-20.0 years) were included, resulting in an overall participation-rate of 30%. Blood samples were drawn, and a thorough clinical examination was performed in all participating children | 209 healthy Danish children (108 girls), were examined and blood samples were drawn every 6 months. In july 2011, the mean (range) number of examinations per child was 7 (2-10). 116 (63 boys and 53 girls) continued from the cross sectional study to the longitudinal study. | Total of all reporting groups |
| Overall Participants | 1748 | 209 | 1957 |
| Age (Count of Participants) | |||
| <=18 years |
1748
100%
|
209
100%
|
1957
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Full Range) ] | |||
| Mean (Full Range) [years] |
11.8
|
11.8
|
11.8
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1044
59.7%
|
108
51.7%
|
1152
58.9%
|
| Male |
704
40.3%
|
101
48.3%
|
805
41.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
1748
100%
|
209
100%
|
1957
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| Denmark |
1748
100%
|
209
100%
|
0
0%
|
Outcome Measures
| Title | Pubertal Onset |
|---|---|
| Description | Pubertal onset (according to Tanner stageing - Marshall & Tanner 1969 and 1970), i.e. Tanner stages B2+ or G2+ [Tanner stages included genital stages 1-5 as well as pubic hairs tages 1-6] Data of both arms were pooled for calculation of means. |
| Time Frame | up to 8 year period. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Population |
| Arm/Group Title | Cross- Sectional Cohort | Longitudinal Cohort |
|---|---|---|
| Arm/Group Description | Schools were randomly selected and 6203 children (50.0 % girls) were invited to participate (overall participation-rate: 30%). Blood samples were drawn, and a thorough clinical examination was performed in all participating children | 209 healthy Danish children (108 girls), were examined and blood samples were drawn every 6 months. |
| Measure Participants | 1748 | 209 |
| Girls |
9.86
|
9.86
|
| Boys |
11.66
|
11.66
|
Adverse Events
| Time Frame | 6 years | |
|---|---|---|
| Adverse Event Reporting Description | No serious and/or other adverse events did occur | |
| Arm/Group Title | Population | |
| Arm/Group Description | This is a descriptive study elucidating normal variation. Therefore, the study population is not grouped | |
All Cause Mortality |
||
| Population | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/1957 (0%) | |
Serious Adverse Events |
||
| Population | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/1957 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Population | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/1957 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Anders Juul |
|---|---|
| Organization | Rigshospitalet |
| Phone | +45 3545 5085 |
| Anders.Juul@regionh.dk |
- KF01282214