View clinical trials related to Idiopathic Short Stature.
Filter by:To explore the dose-response relationship between pharmacokinetics and pharmacodynamics of Y- Shaped Pegylated growth hormone injection (YPEG-GH) in children with short stature (idiopathic short stature (ISS), small for gestational age (SGA), Turner syndrome (TS)). To evaluate its tolerability, safety and efficacy and to provide evidence for dose selection and titration for future clinical development and clinical application in these population.
Growth hormone therapy will improve the height of idiopathic short statured children. DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to non-treatment group in efficacy and safety.
This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.
This is an open-label, multi-center, randomized, two-arm parallel, no-treatment group controlled (only for the first 6 months), Phase 3 study in children with ISS. The subjects will be treated with 0.067 milligram/kilogram/day (mg/kg/day) of Saizen®, weight base dose, for 12 months (12 months of treatment in the test group, and 6 months of no treatment and then 6 months of treatment in the control group).
This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height. A subgroup of children small for their gestational age is included.
It is now widespread practice to treat children with short stature with growth hormone. However, how an individual child will respond to growth hormone treatment is unpredictable and highly variable. Some children will not respond to growth hormone treatment at all. Currently, the only way to determine how well growth hormone therapy is working is to wait until they have been treated for six months and to compare the pre-treatment growth velocity with the growth velocity on treatment. It would be helpful to have a blood test that could be done shortly after starting growth hormone that could predict whether how well a child is responding to treatment. Such a blood test would allow endocrinologists to adjust the growth hormone dose (or possibly stop it altogether, if it is not working) long before the six months it currently takes. C-type natriuretic peptide (CNP) and its partner amino-terminal propeptide of CNP (NTproCNP) are proteins that play a critical role in regulating growth. The investigators have previously shown that blood levels of these proteins increase in children being treated with growth hormone. The investigators believe that a blood test for these proteins will be useful in predicting a child's response to growth hormone treatment. The purpose of this study is to determine when after starting growth hormone, the blood levels of CNP and NTproCNP start to increase.
This trial is conducted in United States of America (USA). The aim of this trial is to examine the bioequivalence of Norditropin® versus Genotropin® in healthy adult volunteers.
When treating very short children in puberty we are time-limited, as sex hormones cause the growth plates to fuse and growth to end. Growth Hormone (GH), plus drugs that stop puberty, increase height potential, but leave children sexually infantile at a critical time in development. Human and animal data show that estrogen, in females and males, is a principal regulator of the fusion of the growth plate in puberty. Using aromatase inhibitors (AIs), which block testosterone to estrogen conversion, in boys with different growth disorders, we have shown that AIs may have beneficial effects enhancing height potential in growth-retarded males, without affecting their puberty. However, no direct comparison of the effect of AIs alone vs. conventional GH treatment has been done to date. This study will assess the effect of AIs alone, GH alone and combination treatment in enhancing height potential in adolescent boys with idiopathic short stature.
The research aims to provide data on gender-related psychological impact of GH (Growth Hormone)treatment. Implicit measurable psychological metrics of the therapy outcome on males are to be evaluated in a Prospective Randomized Controlled Trial. As a secondary axis of the study, the investigators aim to provide descriptive documentation of the unique distress signal manifestation implicitly shown by Idiopathic Short Stature (ISS) boys and suggest methods of early detection and measurement of such manifestations that can be used to cement guidelines for the treatment in GH.
The investigators hypothesize that low serum ghrelin levels may characterize a group of patients with poor weight gain and/or linear growth who do not have any other identified cause for growth failure. These patients may present with a variety of complaints and are often evaluated by both pediatric endocrinologists and pediatric gastroenterologists. The investigators hypothesize that ghrelin has a physiologically important role in linear growth and that chronic diseases of the gastrointestinal system, such as H. Pylori infection or celiac disease, may alter serum ghrelin levels in children. Low ghrelin levels may be a factor leading to poor growth, potentially by altering growth hormone secretion and/or by decreasing appetite. By measuring ghrelin levels in children with short stature and in children with gastrointestinal disease, the investigators will further elucidate the possible physiologic role of ghrelin in childhood growth and how it may be altered in conditions causing short stature and in certain gastrointestinal diseases.