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Biochemical Markers of Growth Response to GH Treatment in Children With Idiopathic Short Stature (ISS)
This study is ongoing, but not recruiting participants.

First Received on April 8, 2007.   Last Updated on November 1, 2011   History of Changes
Sponsor: Rabin Medical Center
Collaborator: Pfizer
Information provided by (Responsible Party): Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00458263
  Purpose

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


Condition Intervention Phase
Idiopathic Short Stature
Drug: Somatotropin growth hormone recombinant human
Phase IV

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: One Arm, Open Study to Assess Biochemical Markers of Growth Response to GH Treatment in Children With Idiopathic Short Stature

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: April 2006
Estimated Study Completion Date: December 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single arm Drug: Somatotropin growth hormone recombinant human
daily SC injections

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   3 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458263

Locations
Israel
schneider children medical center of Israel
Petach Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center
Pfizer
Investigators
Principal Investigator: Moshe Phillip, Prof, MD Schneider Children Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00458263     History of Changes
Other Study ID Numbers: rmc003515ctil
Study First Received: April 8, 2007
Last Updated: November 1, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
GH treatment
ISS
Biochemical markers
Growth response

Additional relevant MeSH terms:
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012