Growth and Metabolic Response to GH and GnRHa Treatment Versus GH Alone in Boys Born SGA.
Two Arms, Open, Controlled, Prospective, Intervention Study to Evaluate the Growth and Metabolic Response to Growth Hormone and Gonadotropin-releasing Hormone Agonist Treatment Versus Growth Hormone Alone in Boys Born SGA
2 other identifiers
interventional
17
1 country
1
Brief Summary
A 2-arms randomized open prospective intervention study to determine the Growth and metabolic response to growth hormone and gonadotropin-releasing hormone agonist treatment versus growth hormone alone in boys born SGA. All subjects will be treated with NorditropinSimplex at a dosage of 100mcg/kg/d. At onset of puberty, subjects will be randomized into either combined treatment with GH and GnRHa or GH alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 29, 2007
CompletedFirst Posted
Study publicly available on registry
August 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJuly 14, 2010
July 1, 2010
5.2 years
August 29, 2007
July 13, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Height measurements
every 3 monthes, during all study period
Secondary Outcomes (6)
IGF-1 concentration
every 6 monthes, during all study period
Hormone profile, Lipid and lipoprotein concentrations
once a year during all study period
Prepubertal changes
every 3 monthes during all study peiod
Bone age
once a year, during all study period
quality of life questionnaire
once a year, during all study period
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALGH \& GNRHa treatment
2
ACTIVE COMPARATORGH treatment
Interventions
Eligibility Criteria
You may qualify if:
- Boys
- IUGR
- Ages 10-13
- height of at list 2.0 standard deviations below the mean height for chronological age and sex according to the 2000 standards from the Centers for Disease Control and Prevention (CDC)
- Prepubertal (tanner stage 1) at commencement of trail
- Peak GH above 10ng/ml in at least one provocative test for GH secretion 7.Signed informed consent
You may not qualify if:
- Growth retardation associated with malignancy, severe chronic disease, genetic syndromes and endocrine disorders
- Diabetes
- Treatment with any medical product which may interfere with GH effects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rabin Medical Centerlead
- Pfizercollaborator
Study Sites (1)
Schnider children medical center
Petah Tikva, Israel
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Moshe Phillip, Professor
Rabin Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 29, 2007
First Posted
August 30, 2007
Study Start
May 1, 2005
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
July 14, 2010
Record last verified: 2010-07