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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00840944
Other study ID # EUDRACT 2007-003247-70
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date January 2008
Est. completion date April 2024

Study information

Verified date July 2023
Source Belgian Study Group for Pediatric Endocrinology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Estrogens are responsible for the disappearance of growth cartilage in the long bones at the end of the pubertal growth spurt both in boys and in girls. It is therefore hypothesized that stopping pubertal development and hence estrogen production, will prolong and increase the pubertal growth spurt, especially when growth hormone is given concommitantly. Boys in early puberty, with a bone age between 11 and 13 years and a predicted adult height below 163 cm or girls in early puberty with a bone age between 10 and 12 years and a predicted height under 151 cm will be treated with triptorelin 3.75 mg and Zomacton growth hormone for 4 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 44
Est. completion date April 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 7 Years to 15 Years
Eligibility Inclusion Criteria: - Adult height prediction below -2.5 SD : 151 cm for girls and 164 cm for boys based on the vlaamse groeicurve 2004 (vub.ac.be/groeicurven) - Pubertal: breast development at least M2 for girls and at least 4 ml of testicular volume for boys - Bone age >10 years but < 12 years for girls and > 11 but < 13 years for boys - Signed informed consent Exclusion Criteria: - Adopted children ( different genetic background, lack of data on birth parameters and parents) - Bone dysplasia or sitting height/ total height > 2 SDS on standards by Gerver et al (see appendix) - Chronic use of glucocorticoids - Previous growth promoting therapy such as GH, sex steroids, oxandrolone, - Known GH deficiency - Chronic infectious disease - Active rheumatic disease - Previously diagnosed or currently suspected malignancy - Sex steroid therapy - Diabetes mellitus - Renal insufficiency (serum creatinine > 1.5 mg/dl) - Hepatic disease ( liver test > 4 fold upper limit of normality) - Current congestive heart failure - Inability to follow the study protocol - Treatment with a non registered drug during the last 30 days before the moment of inclusion.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
somatropin
somatropin 0.050 mg/kg/day
triptorelin
triptorelin 3.75 mg each month

Locations

Country Name City State
Belgium Kinderziekenhuis UZ Brussel Brussel
Belgium Hopital Universitaire Reine Fabiola (HUDERF) Brussels
Belgium Antwerp University Hospital Edegem Antwerpen
Belgium Kinderziekenhuis UGent Gent Oost Vlaanderen
Belgium Jessah Ziekenhuis Hasselt Limburg
Belgium CHU ND-des Bruyères Liege

Sponsors (1)

Lead Sponsor Collaborator
Belgian Study Group for Pediatric Endocrinology

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary height Difference between predicted height at start of treatment and adult height 6 - 8 years
Secondary bone density Bone density SDS measured by DEXA 6 - 8 years
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