Status:
COMPLETED
Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature
Lead Sponsor:
Rabin Medical Center
Collaborating Sponsors:
Pfizer
Conditions:
Idiopathic Short Stature
Eligibility:
All Genders
3-9 years
Phase:
PHASE4
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 parti...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00458263
Start Date
April 1 2006
End Date
May 1 2011
Last Update
January 3 2013
Active Locations (1)
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1
schneider children medical center of Israel
Petah Tikva, Israel, 49202