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

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ClinicalTrials.gov Identifier: NCT00458263
Recruitment Status : Completed
First Posted : April 10, 2007
Last Update Posted : January 3, 2013
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Rabin Medical Center

April 8, 2007
April 10, 2007
January 3, 2013
April 2006
May 2011   (Final data collection date for primary outcome measure)
  • Height [ Time Frame: every 4 months ]
  • Growth velocity [ Time Frame: every 4 months ]
  • Height at beginning of puberty [ Time Frame: At the biginning of puberty ]
  • Final height [ Time Frame: When acheiving final height ]
  • Height
  • Growth velocity
  • Height at beginning of puberty
  • Final height
Complete list of historical versions of study NCT00458263 on ClinicalTrials.gov Archive Site
  • Psychological parameters [ Time Frame: once a year ]
  • HbA1c and IGF-1 [ Time Frame: at baseline. after 3 months and than every 6 months ]
Psychological parameters
Not Provided
Not Provided
 
Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature
One Arm, Open Study to Assess 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.

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.
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Idiopathic Short Stature
Drug: Somatotropin growth hormone recombinant human
daily Sub Cutaneous injections
Experimental: single arm
Intervention: Drug: Somatotropin growth hormone recombinant human
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
20
May 2011
May 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
3 Years to 9 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00458263
rmc003515ctil
No
Not Provided
Not Provided
Rabin Medical Center
Rabin Medical Center
Pfizer
Principal Investigator: Moshe Phillip, Prof, MD Schneider Children Medical Center
Rabin Medical Center
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP