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

NCT00458263

Last updated date
Study Location
schneider children medical center of Israel
Petach Tikva, , 49202, Israel
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Short Stature
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-9 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
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, MDSchneider 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