A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height

Idiopathic Short Stature Clinical Trial

— ZomaTrip  

Official title:

Efficacy and Safety of a 4 Year Combination Therapy of Growth Hormone and Gonadotropin- Releasing Hormone Agonist in Children With a Short Predicted Height.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00840944
• Other study ID #: EUDRACT 2007-003247-70
• Status: Active, not recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Dwarfism
• Idiopathic Short Stature

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