Endocrine Abstracts

Introduction: PATRO Adults is an ongoing, longitudinal, noninterventional study assessing the long-term safety and efficacy of Omnitrope® (Sandoz; recombinant human growth hormone [rhGH]), among adults with severe growth hormone deficiency (GHD) treated in routine clinical practice in European countries. Omnitrope® was approved by the European Medicines Agency (EMA) in 2006, representing the first biosimilar approved by the EMA. We report the la...

Introduction: The ongoing, international, open, longitudinal, non-interventional study, PATRO Adults, aims to determine the long-term safety and efficacy of Omnitrope® (Sandoz), a recombinant human growth hormone (rhGH). Safety data from an interim analysis are presented here.Methods: Eligible patients are male or female adults who are receiving treatment with Omnitrope® and who have provided informed consent. Patients tre...

Introduction: PATRO adults is an international, longitudinal, non-interventional study of the long-term safety and efficacy of recombinant human growth hormone (rhGH; Omnitrope®, Sandoz). The study will provide additional data on the long-term safety of rhGH in adult patients with severe GH deficiency (GHD). Here, we present safety data from an interim analysis.Methods: Eligible patients are adults who are receiving treatment with Omnitro...

Introduction: More data are needed to confirm the long-term safety of recombinant human GH (rhGH) in adult patients with severe GH deficiency (GHD), particularly with regard to diabetogenic potential. PATRO Adults is an ongoing observational, multicentre, open, longitudinal study of Omnitrope, being conducted in hospitals and specialised endocrinology clinics across Europe. Here, we present safety data from an interim analysis.Methods: Eligible patients ...

Introduction: Omnitrope® (Sandoz) is a recombinant human growth hormone (rhGH) and was the first biosimilar medicine approved by the European Medicines Agency. PATRO Adults is an international, longitudinal, non-interventional study of the long-term safety and efficacy of Omnitrope® in adults treated in routine clinical practice. The study provides data on the long-term safety of rhGH in adult patients with severe GH deficiency (GHD). Here we pr...

Introduction: PATRO adults is an ongoing, international, open, longitudinal, non-interventional study of the long-term safety and efficacy of recombinant human GH (rhGH; Omnitrope, Sandoz). The study will provide further data on the long-term safety of rhGH in adult patients with severe GH deficiency (GHD). Here, we present safety data from an interim analysis.Methods: Adults who are receiving treatment with Omnitrope and who have provided informed conse...

Introduction: PATRO adults is an ongoing, international, open, longitudinal, non-interventional study of the long-term safety and efficacy of Omnitrope (Sandoz), a recombinant human GH (rhGH). This study will provide additional data on the long-term safety of rhGH in adult patients with severe GH deficiency (GHD). Here, we present safety data from an interim analysis.Methods: Eligible patients are male or female adults who are receiving treatment with Om...

Background: Clinically non-functioning pituitary macroadenomas (NFMA) have been reported to express various somatostatin receptor (SSTR) subtypes, but results are inconsistent across different studies. This may be related to limited sensitivity and specificity of techniques used to date, i.e. immunohistochemistry in surgical specimens and 111In-DTPA-octreotide scintigraphy (Octreoscan) in vivo. The aim of this study was to assess SSTR expression in NFMA <em...

Rationale: At present, there is no approved medical treatment for patients with clinically non-functioning pituitary adenoma. A number of open-label studies suggest that treatment with somatostatin analogues may prevent tumour progression in selected patients. In vivo assessment of somatostatin receptor status using 68Ga-DOTATATE PET could help to select patients responsive to treatment.Trial objective: To investigate the effect of the somatosta...