Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2011-05-31

Brief Summary

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One arm, open, prospective, intervention study to assess biochemical markers of growth response to Growth Hormone treatment in 20 Children, aged 3-9 years old, with idiopathic short stature. All participants will be treated with Growth Hormone during the first year of the study (and then in accordance with the local ethic requirement, to supply drug which is not approved for the indication used in the study, for additional 3 years) and then will be followed up for the next 3 years. The impact of Growth Hormone therapy on clinical laboratory parameters that are indicative of the growth response will be assessed by collecting blood and urine samples during the 4 years study period. The primary endpoints are measurements of height and growth velocity during the year of Growth Hormone treatment, the height at the beginning of puberty and final height. Secondary endpoints are psychological parameters, assessed by questionnaires.

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Detailed Description

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One arm, open prospective intervention study to assess biochemical markers of growth response to Growth Hormone treatment in 20 children, aged 3-9 years old, with idiopathic short stature.

Objectives:

1. To determine axiological and biochemical markers for growth response
2. To assess the period of time necessary to determine the parameters which will differentiate between responders and non-responders

Inclusion criteria:

1. Ages 3 to \<9 years
2. Short stature with height \>2.25 Standard Deviation below the mean
3. Prepubertal (Tanner stage I) at commencement of trial
4. Peak Growth Hormone above 10ng/ml in at least one provocative test for Growth Hormone secretion
5. Signing Informed consent forms

Exclusion criteria:

1. Intra Uterine Growth Retardation
2. Growth retardation associated with malignancy, severe chronic disease, genetic syndromes and endocrine disorders
3. Diabetes
4. Treatment with any medical product which may interfere with Growth Hormone effects

Methods:

1. All participants will be treated with Growth Hormone during the first year of the study (and then in accordance with the local ethic requirement, to supply drug which is not approved for the indication used in the study, for additional 3 years) and then will be followed up for the next 3 years.
2. The impact of Growth Hormone therapy on clinical laboratory parameters that are indicative of the growth response will be assessed by collecting blood and urine samples during the 4 years study period.Samples will be test for biochemical markers of bone formation and resorption
3. The primary endpoints are measurements of height and growth velocity during the year of Growth Hormone treatment, the height at the beginning of puberty and final height. Secondary endpoints are psychological parameters, assessed by questionnaires.

Conditions

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Idiopathic Short Stature

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single arm

Group Type EXPERIMENTAL

Somatotropin growth hormone recombinant human

Intervention Type DRUG

daily Sub Cutaneous injections

Interventions

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Somatotropin growth hormone recombinant human

daily Sub Cutaneous injections

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ages 3 to \<9 years
* Short stature with height \>2.25 Standard Deviation below the mean
* Prepubertal (Tanner stage I) at commencement of trial
* Peak Growth Hormone above 10ng/ml in at least one provocative test for Growth Hormone secretion
* Signing informed consent forms

Exclusion Criteria

* Intra Uterine Growth Retardation
* Growth retardation associated with malignancy, severe chronic disease, genetic syndromes and endocrine disorders
* Diabetes
* Treatment with any medical product which may interfere with Growth Hormone

Minimum Eligible Age

3 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No