Idiopathic Short Stature
Conditions
Keywords
gonadotropin releasing hormone agonist, growth hormone, final height, bone density, puberty
Brief 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.
Interventions
DRUGsomatropin
somatropin 0.050 mg/kg/day
DRUGtriptorelin
triptorelin 3.75 mg each month
Sponsors
Belgian Study Group for Pediatric Endocrinology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| height | 6 - 8 years | Difference between predicted height at start of treatment and adult height |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bone density | 6 - 8 years | Bone density SDS measured by DEXA |
Countries
Belgium
Outcome results
None listed