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NCT Number: NCT00458263

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

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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Key information

Conditions

Idiopathic Short Stature

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

schneider children medical center of Israel

Petah Tikva, 49202, Israel

About this study

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:

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

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 effects

Methods:

  • 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.Samples will be test for biochemical markers of bone formation and resorption
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatotropin growth hormone recombinant human

Drug

daily Sub Cutaneous injections

Primary outcomes

  1. Height

    Time frame: every 4 months

  2. Growth velocity

    Time frame: every 4 months

  3. Height at beginning of puberty

    Time frame: At the biginning of puberty

  4. Final height

    Time frame: When acheiving final height

Secondary outcomes

  1. Psychological parameters

    Time frame: once a year

  2. HbA1c and IGF-1

    Time frame: at baseline. after 3 months and than every 6 months

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Collaborators

  • Pfizer

Registry information

Official study title

One Arm, Open Study to Assess Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature

Acronym: ISS

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Apr 10, 2007
Registry last updated
Jan 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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