hrp0082p2-d3-442 | Growth Hormone (2) | ESPE2014

Two-Year Results from Patro Children, a Multi-Centre, Non-Interventional Study of the Long-Term Efficacy and Safety of Omnitrope® in Children Requiring GH Treatment

Pfaffle Roland , Kanumakala Shankar , Hoybye Charlotte , Kristrom Berit , Schuck Ellen , Zabransky Markus , Battelino Tadej , Colle Michel

Background: PATRO children is an international, open, longitudinal, noninterventional study of the long-term safety and efficacy of Omnitrope®, a biosimilar recombinant human GH (rhGH).Objective and hypotheses: The primary objective is to assess the long-term safety of Omnitrope®, particularly the diabetogenic potential of GH in short children born small for gestational age, the risk of malignancies, and potential risks of...

hrp0084p2-413 | GH & IGF | ESPE2015

Results up to January 2015 from PATRO Children, a Multi-Centre, Non-Interventional Study of the Long-Term Safety and Efficacy of Omnitrope® in Children Requiring GH Treatment

Pfaffle Roland , Kanumakala Shankar , Hoybye Charlotte , Kristrom Berit , Schuck Ellen , Zabransky Markus , Battelino Tadej , Colle Michel

Background: PATRO Children is an international, open, longitudinal, non-interventional study designed to evaluate the long-term safety and efficacy of Omnitrope®, a biosimilar recombinant human GH (rhGH).Objective and hypotheses: Long-term safety of Omnitrope® is the primary objective of PATRO Children (particularly the diabetogenic potential of GH in short children born small for gestational age, the risk of malignancies,...

hrp0082p2-d3-440 | Growth Hormone (2) | ESPE2014

Two-Year Data from a Long-Term, Phase IV Study of Omnitrope®, a Recombinant Human GH, in Short Children Born Small for Gestational Age

Schwarz Hans-Peter , Birkholz-Walerzak Dorota , Szalecki Mieczyslaw , Walczak Mieczyslaw , Galesanu Corina , Metreveli David , Khan-Boluki Jasmin , Schuck Ellen

Background: Children born small for gestational age (SGA) are predisposed to metabolic abnormalities. While the therapeutic benefit of recombinant human growth hormone (rhGH) therapy in improving height is widely recognised, it can affect carbohydrate metabolism, potentially inducing diabetes.Objective and hypotheses: This ongoing, prospective study aims to evaluate the long-term safety and efficacy of Omnitrope® (somatropin) in children ...