NCT00840944

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Belgian Study Group for Pediatric Endocrinology · Academic / Other
• Sex: All
• Age: 7 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Short Stature

Interventions

Type	Name	Description
DRUG	somatropin	somatropin 0.050 mg/kg/day
DRUG	triptorelin	triptorelin 3.75 mg each month

Timeline

• Start date: 2008-01-01
• Primary completion: 2024-01-01
• Completion: 2024-04-01
• First posted: 2009-02-11
• Last updated: 2023-07-28

Locations

6 sites across 1 country: Belgium