ESPE Abstracts

Background: Early TS diagnosis permits early GH start and estradiol (E2) supplementation, approaching adult height (AH) at normal age and within normal range. However, higher age at diagnosis is still a challenge according to age for puberty induction and AH.Objective and hypotheses: The objective from our long term trials is knowledge enough for personalized treatment in order to obtain a psychological acceptable age at onset of puberty and still an att...

Background: Due to fewer girls than boys being GH-treated, after 50yrs the knowledge about sex-differences in both GH-response and GH-responsiveness before and during puberty remains limited.Aim: To describe factors explaining growth response to GH-treatment, separately in girls and boys from GHstart to adult height (AH).Methods: Children diagnosed with IGHD/ISS/SGA from GH-SAFETY-...

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®...

Background: The estimated estradiol (E2) dose required for pubertal induction in hypogonadal girls is about 1/10 of the adult dose. Previous studies have shown that it is possible to provide an individualized and physiological dose for pubertal induction by cutting the patch into smaller pieces. However, the manufacturers do not guarantee stability or utility of cut E2 patches, primarily designed for postmenopausal women, and have no interest in that eval...

Background: Endogenous GH pattern is characterized by high peaks (growth signal) and low trophs (metabolic signal). Exogenous GH is given by subcutaneous injection (scGH-injection) daily at bedtime.Objective and hypotheses: To study the factors influencing intra-/interindividual variation of pharmacokinetics and pattern of scGH-injection in GH treated children.Method: One hundred and twenty eight subjects followed yearly ≤ 8 ...

Background: GH-secretion rates for children ranges in pre/early puberty 0.1–11 U/24 h and during mid-puberty 4–40 U/24 h. This can be used to optimize the rhGH treatment doses in children.Objective and hypotheses: To calculated the bioavailable rhGH in relation to injected dose and compare this to GH-secretory rate in healthy children; and to investigate factors influencing bioavailability.Method: One hundred and twenty e...

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...

Background: Cognitive function has been shown to improve following GH treatment in adults. In children born small for gestational age (SGA) IQ scores were found to improve following 24 months of GH treatment.Objective and hypotheses: The aim was to observe cognitive function in pre-pubertal, short children with isolated GH deficiency (IGHD) or idiopathic short stature (ISS) during the first 24 months of GH treatment. Cognitive testing was carried out usi...

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...

Background: Early TS diagnosis permits early GH start and estradiol (E2) supplementation approaching adult height (AH) at normal age and within a normal range. However, higher age at diagnosis is still a challenge.Objective and hypotheses: The hypothesis from our long-term trials will result in knowledge for personalized treatment in order to obtain a psychological acceptable age at onset of puberty and still an attained AH within normal range...