NCT00488124

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Idiopathic Short Stature

Interventions

Type	Name	Description
DRUG	somatropin (Genotropin® treatment)	0,035 mg /kg bodyweight of Somatropin per day given by subcutaneous injections through an injection device (GenotropinPEN)

Timeline

• Start date: 2005-11-01
• Primary completion: 2011-02-01
• Completion: 2011-03-01
• First posted: 2007-06-19
• Last updated: 2020-12-14

Locations

13 sites across 1 country: Germany