CONTEXT: The detection of exogenously administered growth hormone (GH) poses a formidable challenge but a detection method based on the measurement of two GH-dependent markers, IGF-I and type 3 pro-collagen (P-III-P) has been proposed. The measurement of multiple markers in conjunction with discriminant functions can improve the sensitivity and specificity of detection compared with single marker analysis. OBJECTIVE: To provide further validation of the GH-dependent marker approach. DESIGN: Analysis of discriminant function scores for GH detection on independent datasets. SETTING: Two independent (GH-2000 and Kreischa) double blind, placebo controlled, hGH administration studies. SUBJECTS:Healthy active male volunteers. INTERVENTION: GH-2000 proposed a discriminant function involving IGF-I and P-III- P while the Kreischa function involved IGF-I, P-III-P and IGFBP-3. After adjustment for assay differences the formulae were applied to the other dataset. OUTCOME MEASURES: Ability to detect GH use in independent datasets using a predefined specificity of approximately 1 in 10000. RESULTS: The GH-2000 formula was able to detect 90% of those receiving GH in the Kreischa study at one or more time points during the study period. This sensitivity was similar to that obtained on the original GH-2000 dataset. The Kreischa formula correctly identified 41% of individuals receiving GH in the GH-2000 study. CONCLUSIONS: The study provides further validation that the test proposed by GH-2000 based on IGF-I and P-III-P concentrations can be used to detect subjects receiving exogenous GH.
RCT Entities:
CONTEXT: The detection of exogenously administered growth hormone (GH) poses a formidable challenge but a detection method based on the measurement of two GH-dependent markers, IGF-I and type 3 pro-collagen (P-III-P) has been proposed. The measurement of multiple markers in conjunction with discriminant functions can improve the sensitivity and specificity of detection compared with single marker analysis. OBJECTIVE: To provide further validation of the GH-dependent marker approach. DESIGN: Analysis of discriminant function scores for GH detection on independent datasets. SETTING: Two independent (GH-2000 and Kreischa) double blind, placebo controlled, hGH administration studies. SUBJECTS: Healthy active male volunteers. INTERVENTION: GH-2000 proposed a discriminant function involving IGF-I and P-III- P while the Kreischa function involved IGF-I, P-III-P and IGFBP-3. After adjustment for assay differences the formulae were applied to the other dataset. OUTCOME MEASURES: Ability to detect GH use in independent datasets using a predefined specificity of approximately 1 in 10000. RESULTS: The GH-2000 formula was able to detect 90% of those receiving GH in the Kreischa study at one or more time points during the study period. This sensitivity was similar to that obtained on the original GH-2000 dataset. The Kreischa formula correctly identified 41% of individuals receiving GH in the GH-2000 study. CONCLUSIONS: The study provides further validation that the test proposed by GH-2000 based on IGF-I and P-III-P concentrations can be used to detect subjects receiving exogenous GH.
Authors: Shalender Bhasin; E Jiaxiu He; Miwa Kawakubo; E Todd Schroeder; Kevin Yarasheski; Gregory J Opiteck; Alise Reicin; Fabian Chen; Raymond Lam; Jeffrey A Tsou; Carmen Castaneda-Sceppa; Ellen F Binder; Stanley P Azen; Fred R Sattler Journal: J Clin Endocrinol Metab Date: 2009-10-16 Impact factor: 5.958
Authors: Luca Narduzzi; Corinne Buisson; Marie-Line Morvan; Alexandre Marchand; Michel Audran; Yves Le Bouc; Emmanuelle Varlet-Marie; Magnus Ericsson; Bruno Le Bizec; Gaud Dervilly Journal: Front Mol Biosci Date: 2021-06-10