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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2024-04-30

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.

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Detailed Description

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Conditions

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Idiopathic Short Stature

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ZOMATRIP

GnRH agonist triptorelin plus somatropin

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

somatropin 0.050 mg/kg/day

triptorelin

Intervention Type DRUG

triptorelin 3.75 mg each month

Interventions

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somatropin

somatropin 0.050 mg/kg/day

Intervention Type DRUG

triptorelin

triptorelin 3.75 mg each month

Intervention Type DRUG

Other Intervention Names

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growth hormone zomacton decapeptyl

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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No