Effect of Increlex® on Children With Crohn Disease
Status:
Terminated
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
Patients with Crohn disease often have poor weight gain and short stature, yet the etiology
of the poor growth is not well defined. Studies in chronically ill patients who do not have
Crohn disease have suggested that inflammation causes IGF-1 deficiency due to inadequate
IGF-1 generation. Previous studies of GH use in Crohn patients have demonstrated improvement
in linear growth, weight and bone mineralization. However, GH can cause glucose intolerance
in chronically ill children, particularly those who require treatment with corticosteroids.
Recently the FDA has approved recombinant IGF-1 (rhIGF) for treatment of IGF-1 deficient
short stature. This medication has not been studied in Crohn disease. The purpose of this
study is to test the hypothesis that poor growth in Crohn disease is associated abnormal
IGF-1 generation which leads to poor linear growth, decreased weight and osteoporosis and
that replacement of IGF-1 with rhIGF will correct growth and improve bone density. To test
our hypothesis we will recruit 20 patients with Crohn disease from our pediatric
gastroenterology practice. Each will have been previously diagnosed with Crohn disease for a
minimum of one year and will be studied at baseline and six month intervals for one year
while on treatment with Increlex.