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AAP Grand Rounds 15:9-10 (2006) Long-Term Growth Hormone Treatment of Idiopathic Short StatureSource: Kemp SF, Kuntze J, Attie KM, et al. Efficacy and safety results of long-term growth hormone treatment of idiopathic short stature. J Clin Endocrinol Metab. 2005; 90:52475253.
These authors, including researchers from the University of Arkansas, Little Rock, and Genentech, Inc., South San Francisco, Calif., and consultants from the United States and Brazil, evaluated data from the observational National Cooperative Growth Study (NCGS), a multi-center postmarketing surveillance study established by Genentech in 1985 to evaluate the use, safety, and efficacy of Genentechs biosynthetic human growth hormone (GH) products for the treatment of idiopathic short stature (ISS) in more than 8000 North American children. ISS is defined as short stature of unknown etiology in a child whose height is more than 2.25 Standard Deviation scores (SDS) below the mean and who is considered unlikely to reach a normal adult height. Data from these patients were assessed for safety, and efficacy analysis was performed on 3 subcohorts of patients based upon age and pubertal status at baseline. Patients were identified as having ISS if they met any of the following 3 criteria: a maximum stimulated growth hormone of 10 ng/ml or greater with text information confirming a physician diagnosis of ISS; a maximum stimulated GH of 10 ng/ml or greater and the
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