Trial Outcomes & Findings for The COPENHAGEN Puberty Study (NCT NCT01411527)
NCT ID: NCT01411527
Last Updated: 2019-10-10
Results Overview
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.
COMPLETED
1957 participants
up to 8 year period.
2019-10-10
Participant Flow
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)
No participants were excluded
Participant milestones
| Measure |
Cross- Sectional Cohort
Schools were randomly selected. Blood samples were drawn, and a thorough clinical examination was performed in all participating children
|
Longitudinal Cohort
Healthy Danish children were examined and blood samples were drawn every 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
1864
|
93
|
|
Overall Study
COMPLETED
|
1864
|
93
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The COPENHAGEN Puberty Study
Baseline characteristics by cohort
| Measure |
Cross- Sectional Cohort
n=1748 Participants
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
n=209 Participants
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
n=1957 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1748 Participants
n=99 Participants
|
209 Participants
n=107 Participants
|
1957 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
11.8 years
n=99 Participants
|
11.8 years
n=107 Participants
|
11.8 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1044 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
1152 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
704 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
805 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1748 Participants
n=99 Participants
|
209 Participants
n=107 Participants
|
1957 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Denmark
|
1748 participants
n=99 Participants
|
209 participants
n=107 Participants
|
0 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 8 year period.Population: Population
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.
Outcome measures
| Measure |
Cross- Sectional Cohort
n=1748 Participants
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
|
Longitudinal Cohort
n=209 Participants
209 healthy Danish children (108 girls), were examined and blood samples were drawn every 6 months.
|
|---|---|---|
|
Pubertal Onset
Girls
|
9.86 years
Interval 9.7 to 10.01
|
9.86 years
Interval 9.7 to 10.01
|
|
Pubertal Onset
Boys
|
11.66 years
Interval 11.49 to 11.82
|
11.66 years
Interval 11.49 to 11.82
|
Adverse Events
Population
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place