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

Who is this study for? Patients with Idiopathic Short Stature
What treatments are being studied? Somatropin+Triptorelin
Status: Active_not_recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 15
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Kinderziekenhuis UZ Brussel
Brussel
Hopital Universitaire Reine Fabiola (HUDERF)
Brussels
Antwerp University Hospital
Edegem
Kinderziekenhuis UGent
Gent
Jessah Ziekenhuis
Hasselt
CHU ND-des Bruyères
Liege
Time Frame
Start Date: 2008-01
Completion Date: 2024-04
Participants
Target number of participants: 44
Treatments
Experimental: ZOMATRIP
GnRH agonist triptorelin plus somatropin
Sponsors
Leads: Belgian Study Group for Pediatric Endocrinology

This content was sourced from clinicaltrials.gov