Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature
Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Nemours Children's Clinic
Collaborators:
AstraZeneca Genentech, Inc. Novartis Pfizer Thrasher Research Fund