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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

Tracking Information
First Submitted Date  ICMJE April 8, 2007
First Posted Date  ICMJE April 10, 2007
Last Update Posted Date January 3, 2013
Study Start Date  ICMJE April 2006
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2007)
  • Height
  • Growth velocity
  • Height at beginning of puberty
  • Final height
Change History Complete list of historical versions of study NCT00458263 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2008)
  • Psychological parameters [ Time Frame: once a year ]
  • HbA1c and IGF-1 [ Time Frame: at baseline. after 3 months and than every 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2007)
Psychological parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature
Official Title  ICMJE One Arm, Open Study to Assess Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature
Brief Summary 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.
Detailed Description

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 1, 2013)
21
Original Enrollment  ICMJE
 (submitted: April 8, 2007)
20
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00458263
Other Study ID Numbers  ICMJE rmc003515ctil
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Moshe Phillip, Prof, MD Schneider Children Medical Center
PRS Account Rabin Medical Center
Verification Date October 2011

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