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| Tracking Information | |||||
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| First Received Date ICMJE | April 8, 2007 | ||||
| Last Updated Date | December 23, 2008 | ||||
| Start Date ICMJE | April 2006 | ||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00458263 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Psychological parameters | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Biochemical Markers of Growth Response to GH Treatment in Children With Idiopathic Short Stature | ||||
| Official Title ICMJE | One Arm, Open Study to Assess Biochemical Markers of Growth Response to GH Treatment in Children With Idiopathic Short Stature | ||||
| Brief Summary | 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 |
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| 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:
Inclusion criteria:
Exclusion criteria:
Methods:
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Idiopathic Short Stature | ||||
| Intervention ICMJE | Drug: Somatotropin growth hormone recombinant human | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | August 2011 | ||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 3 Years to 9 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00458263 | ||||
| Responsible Party | Prof. Moshe Phillip, Rabin Medical Center | ||||
| Study ID Numbers ICMJE | rmc003515ctil | ||||
| Study Sponsor ICMJE | Rabin Medical Center | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
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| Information Provided By | Rabin Medical Center | ||||
| Verification Date | December 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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