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For the IGF-I target groups, dose changes were calculated based on the difference between measured and target IGF-I SDS.
The study was described in detail in a previous publication (15).
We recently published the results of a multicenter study showing that in IGF-deficient patients treated with GH, targeting IGF-I scores (HTSDS) than targeting the IGF-I levels to the population mean or using a conventional body weight based GH dose of 40 μg/kg · d (15).
Because failing a GH-stimulation test was not a required inclusion criterion in this study, the study population was heterogeneous in terms of serum GH levels in response to provocative stimuli.
GH doses were adjusted beginning at the month 1 visit and at each subsequent 3-month visit until the end of study.
In the Conv group, doses were maintained at 40 μg/kg · d and adjusted only for body weight.
IGF-I has been identified as the major mediator of GH-induced somatic growth (6–9).
A GH dosing algorithm based on IGF-I response should therefore more accurately reflect the true GH requirement of a patient and allow optimization of GH treatment.
Arginine (0.5 mg/kg iv over 30 min) and Serum IGF-I (DSL-5600), IGF binding protein (IGFBP)-3 (DSL-6600), and GH (DSL-1900 double monoclonal immunoradiometric assay) assays were performed at Diagnostic Systems Laboratories (Webster, TX).
The normative data set used to calculate the Diagnostic Systems Laboratories IGF-I SDS in children for this study has been assembled with samples from 1875 (1045 male and 830 female) healthy subjects aged 0–20 yr.
It was a 2-yr, open-label, randomized IGF-I concentration-controlled trial.
The null hypothesis was that, during GH therapy in short, IGF-I-deficient children, titrating GH dose to achieve different levels of IGF-I SDS would result in no difference in height increase over 2 yr.
Idiopathic short stature (ISS) is a term used to describe children with non-GHD short stature, in which the etiology of the growth abnormality cannot be identified (10).