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| 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 |
| 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
|
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:
Inclusion criteria:
Exclusion criteria:
Methods:
Eligibility| Ages Eligible for Study: | 3 Years to 9 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Israel | |
| schneider children medical center of Israel | |
| Petach Tikva, Israel, 49202 | |
| Principal Investigator: | Moshe Phillip, Prof, MD | Schneider Children Medical Center |
More Information
| 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 |
|
GH treatment ISS Biochemical markers Growth response |
|
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 |