Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin — ISS  

Idiopathic Short Stature Clinical Trial

Official title: Evaluation of Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin: A Prospective, Longitudinal Non-randomised, Open, Phase II Study

Status Completed

Clinical Trial Summary

Growth hormone therapy will improve the height of short statured children with pathological conditions that lead to growth retardation. Growth hormone therapy will show an increase in height velocity >1 SD compared to pretreatment height velocity. and the therapy will be safe.

Clinical Trial Description

Growth hormone (GH, Somatropin, e.g. Genotropin®) is approved in the treatment of children in specific indications. However, besides the benefit in approved indications, a benefit can also be achieved in other pathological conditions that lead to growth retardation. However, because of their relative low frequency and the long duration of GH studies in children, few data or only case reports on GH treatment are available in these conditions. Nevertheless, published data have suggested a benefit of GH treatment in children suffering from some of those diseases and pediatric endocrinologists sometimes request GH treatment for those children to improve growth rate. This protocol is designed to allow such children with severe growth retardation to be treated with GH and will allow those children to be carefully followed-up and finally evaluated at the end of the GH treatment period. ;

Related Conditions & MeSH terms

• Dwarfism
• Idiopathic Short Stature

• NCT number: NCT00488124
• Study type: Interventional
• Source: University of Erlangen-Nürnberg Medical School
• Status: Completed
• Phase: Phase 2
• Start date: November 2005
• Completion date: March 2011