Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature
NCT00458263
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature | |||
Official Title ICMJE | One Arm, Open Study to Assess Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature | |||
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 participants will be treated with Growth Hormone 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 Growth Hormone 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. The primary endpoints are measurements of height and growth velocity during the year of Growth Hormone treatment, the height at the beginning of puberty and final height. Secondary endpoints are psychological parameters, assessed by questionnaires. | |||
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:
Inclusion criteria:
Exclusion criteria:
Methods:
| |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Idiopathic Short Stature | |||
Intervention ICMJE | Drug: Somatotropin growth hormone recombinant human
daily Sub Cutaneous injections | |||
Study Arms ICMJE | Experimental: single arm
Intervention: Drug: Somatotropin growth hormone recombinant human | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 21 | |||
Original Enrollment ICMJE | 20 | |||
Actual Study Completion Date ICMJE | May 2011 | |||
Actual Primary Completion Date | May 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 3 Years to 9 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Israel | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00458263 | |||
Other Study ID Numbers ICMJE | rmc003515ctil | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Rabin Medical Center | |||
Study Sponsor ICMJE | Rabin Medical Center | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Rabin Medical Center | |||
Verification Date | October 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |