A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height
NCT00840944 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2023-07-28
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
- DRUG
-
somatropin
somatropin 0.050 mg/kg/day
- DRUG
-
triptorelin
triptorelin 3.75 mg each month
Sponsors & Collaborators
-
Belgian Study Group for Pediatric Endocrinology
lead OTHER
Principal Investigators
-
Hilde Dotremont, MD · BSGPE
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 7 Years
- Max Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-01-31
- Primary Completion
- 2024-01-31
- Completion
- 2024-04-30
Countries
- Belgium
Study Locations
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