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Biochemical Markers of Growth Response to GH Treatment in Children With Idiopathic Short Stature (ISS)
This study is currently recruiting participants.
Study NCT00458263   Information provided by Rabin Medical Center
First Received: April 8, 2007   Last Updated: December 23, 2008   History of Changes

April 8, 2007
December 23, 2008
April 2006
June 2011   (final data collection date for primary outcome measure)
  • Height [ Time Frame: every 4 months ] [ Designated as safety issue: No ]
  • Growth velocity [ Time Frame: every 4 months ] [ Designated as safety issue: No ]
  • Height at beginning of puberty [ Time Frame: At the biginning of puberty ] [ Designated as safety issue: No ]
  • Final height [ Time Frame: When acheiving final height ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • HbA1c and IGF-1 [ Time Frame: at baseline. after 3 months and than every 6 months ] [ Designated as safety issue: Yes ]
Psychological parameters
 
Biochemical Markers of Growth Response to GH Treatment in Children With Idiopathic Short Stature
One Arm, Open Study to Assess Biochemical Markers of Growth Response to GH Treatment in Children With Idiopathic Short Stature

One arm, open, prospective, intervention study to assess biochemical markers of growth response to GH treatment in 20 Children, aged 3-9 years old, with idiopathic short stature. All participants will be treated with GH 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 GH 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: bone alkaline phosphatase, osteocalcin, type I procollagen propeptide (PICP), hydroxyproline, pyridinoline, deoxypyridinoline, ICTP, TRAcP, GHL, NTX-I, BSP. The primary endpoints are measurements of height and growth velocity during the year of GH treatment, the height at the beginning of puberty and final height. Secondary endpoints are psychological parameters, assessed by questionnaires. Safety parameters are IGF1 and HbA1c, measured at baseline, 3 month and than every 6 months

One arm, open prospective intervention study to assess biochemical markers of growth response to GH 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 SD below the mean
  3. Prepubertal (Tanner stage I) at commencement of trial
  4. Peak GH above 10ng/ml in at least one provocative test for GH secretion
  5. Signing Informed consent forms

Exclusion criteria:

  1. IUGR
  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 GH effects

Methods:

  1. All participants will be treated with GH 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 GH 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: bone alkaline phosphatase, osteocalcin, type I procollagen propeptide (PICP), hydroxyproline, pyridinoline, deoxypyridinoline, ICTP, TRAcP, GHL, NTX-I, BSP.
  3. The primary endpoints are measurements of height and growth velocity during the year of GH treatment, the height at the beginning of puberty and final height. Secondary endpoints are psychological parameters, assessed by questionnaires.
  4. Safety parameters are IGF1 and HbA1c, measured at baseline, 3 month and than every 6 months
Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Idiopathic Short Stature
Drug: Somatotropin growth hormone recombinant human
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
20
August 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • IUGR
  • Growth retardation associated with malignancy, severe chronic disease, genetic syndromes and endocrine disorders
  • Diabetes
  • Treatment with any medical product which may interfere with GH
Both
3 Years to 9 Years
No
Contact: Moshe Phillip, Prof, MD 972-3-9253778 mosheph@clalit.org.il
Israel
 
NCT00458263
Prof. Moshe Phillip, Rabin Medical Center
rmc003515ctil
Rabin Medical Center
Pfizer
Principal Investigator: Moshe Phillip, Prof, MD Schneider Children Medical Center
Rabin Medical Center
December 2008

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