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

Study Overview
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Brief Summary
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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.

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

Conditions
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Idiopathic Short Stature

Intervention / Treatment
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* Drug: somatropin
* Drug: triptorelin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZOMATRIP<br>GnRH agonist triptorelin plus somatropin | Drug: somatropin<br>* somatropin 0.050 mg/kg/day<br>* Other names: zomacton;Drug: triptorelin<br>* triptorelin 3.75 mg each month<br>* Other names: decapeptyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| height | Difference between predicted height at start of treatment and adult height | 6 - 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone density | Bone density SDS measured by DEXA | 6 - 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gonadotropin releasing hormone agonist, growth hormone, final height, bone density, puberty