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Submitted on December 22, 2004
Accepted on June 23, 2005
University of Arkansas for Medical Sciences at Arkansas Children's Hospital, Little Rock, Ark; Burfordville, Missouri; Rio de Janeiro, Brazil; Genentech, Inc., South San Francisco, California; Santa Monica, California
* To whom correspondence should be addressed. E-mail: KempStephenF{at}uams.edu.
Context: Small clinical trials of growth hormone (GH) treatment of idiopathic short stature (ISS) show variable efficacy.
Objective: Analysis of large GH registry for efficacy and safety of GH treatment of ISS. Comparison to specific clinical trial.
Design: Up to 7 yr of GH treatment of ISS evaluated for efficacy, safety in National Cooperative Growth Study (NCGS).
Setting: NCGS, Genentech, Inc., 47,226 patients.
Patients: ISS= maximum stimulated GH 
10 ng/mL and/or report of ISS by investigator (n = 8018; all included for safety). Cohort 1 (n = 2520): similar to clinical trial, Cohort 2 (n = 283): < 5 yr of age, Cohort 3 (n = 940): pubertal at GH start.
Intervention: GH, approximately 0.30 mg/kg/week.
Main Outcome Measures: Growth velocities (GV), height SD (HtSD).
Results: Mean first year GV in Cohorts 1, 2, and 3 increased 4.6, 3.9, and 4.4 cm/yr over pretreatment, respectively. Baseline mean HtSD: -2.9, -3.2, and -2.8; Mean HtSD at 1 yr: -2.4, -2.3, and -2.3, respectively. Mean HtSDs after 7 yr in Cohorts 1 (n = 303) and 2 (n = 85), and 5 yr in Cohort 3 (n = 58):-1.2, -1.0, and -1.5, respectively. Cohort 3 shorter treatment time due to advanced baseline age (mean 13.8 yr) and puberty. Mean HtSD gain in Cohort 1 comparable to clinical trial. No new safety signals specific to the NCGS ISS population.
Conclusion: ISS patients in GH registry demonstrate significant increase in HtSD with safety profile similar to GH deficient patients. Results similar to clinical trial.
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