hrp0092p1-87 | Growth and Syndromes (to include Turner Syndrome) | ESPE2019

Long-Term Safety Follow-up after Omnitrope® (recombinant human growth hormone) Treatment in Short Children Born Small for Gestational Age (SGA): Latest Results

Walczak Mieczyslaw , Giemza Tomasz , Jathanakodi Shrihari , Zouater Hichem , Zabransky Markus

Background: The benefit of recombinant human growth hormone (rhGH) in improving height is widely recognised; however, rhGH therapy can affect carbohydrate metabolism and lead to impaired glucose tolerance during treatment. In addition, short children born SGA are predisposed to metabolic abnormalities. This study assessed the long-term safety of growth hormone (Omnitrope®) use in short children born SGA for up to 10 years after the end of treat...

hrp0092p1-387 | Growth and Syndromes (to include Turner Syndrome) (2) | ESPE2019

Omnitrope® (Recombinant Human Growth Hormone) in Short Children Born Small for Gestational Age (SGA): A Long-Term, Phase IV Study

Walczak Mieczyslaw , Giemza Tomasz , Jathanakodi Shrihari , Zouater Hichem , Zabransky Markus

Background: Short children born SGA are predisposed to metabolic abnormalities. While the benefit of recombinant human growth hormone in improving height is widely recognised, it can affect carbohydrate metabolism and lead to impaired glucose tolerance during treatment. This ongoing, prospective study is assessing the long-term safety and efficacy of Omnitrope® (somatropin) in children born SGA. Here we present data from an interim analysis con...

hrp0092p2-178 | Growth and Syndromes (to include Turner Syndrome) | ESPE2019

Adult Height of Patients Enrolled in PATRO Children, An Ongoing Observational Study of the Long-term Safety And Effectiveness Of Omnitrope®

Kanumakala Shankar , Backeljauw Philippe , Otfried Schwab Karl , Loche Sandro , Zabransky Markus , Zouater Hichem

Objectives: PATRO Children is an observational, international, longitudinal study of the long-term safety of a recombinant human growth hormone (rhGH; Omnitrope®, Sandoz). The effect of rhGH treatment on growth and adult height (AH) is assessed as a secondary objective of the study.Methods: This ongoing study is conducted in hospitals and specialised endocrinology clinics across 14 countries. The study po...

hrp0089rfc15.6 | Growth and syndromes | ESPE2018

Latest Results from PATRO Children, a Multi-Centre, Non-Interventional Study of the Long-Term Safety and Efficacy of Omnitrope® in Children Requiring Growth Hormone Treatment

Kanumakala Shankar , Pfaffle Roland , Hoybye Charlotte , Kristrom Berit , Battelino Tadej , Zabransky Markus , Zouater Hichem

Objectives: PATRO Children is a non-interventional, international, longitudinal study of the long-term safety of a recombinant human growth hormone (rhGH; Omnitrope®, Sandoz). In particular, the study will assess the diabetogenic potential of rhGH and the risk of malignancies. The long-term efficacy is a secondary objective of the study.Methods: The study population includes infants, children and adolescents receiving Omnitrope®...

hrp0086p1-p634 | Growth P1 | ESPE2016

Four-Year Results from PATRO Children, a Multi-Centre, Non-Interventional Study of the Long-Term Safety and Efficacy of Omnitrope® in Children Requiring Growth Hormone Treatment

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

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

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,...

hrp0092p1-227 | Growth and Syndromes (to include Turner Syndrome) (1) | ESPE2019

Latest Results From PATRO Children, a Multi-Centre, Observational Study of the Long-Term Safety and Effectiveness of Omnitrope® in Children Requiring Growth Hormone Treatment

Kanumakala Shankar , Pfäffle Roland , Höybye Charlotte , Kriström Berit , Battelino Tadej , Zabransky Markus , Zouater Hichem

Objectives: PATRO Children is an observational, international, longitudinal study of the long-term safety of a recombinant human growth hormone (rhGH; Omnitrope®, Sandoz). In particular, the study will assess the impact of rhGH on glucose metabolism and risk of malignancies. Long-term effectiveness is a secondary objective.Methods: The study population includes infants, children and adolescents receiving ...