NCT01248416

Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature

A Randomized Controlled Trial Of The Use Of Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Nemours Children's Clinic · Academic / Other
• Sex: Male
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Short Stature

Interventions

Type	Name	Description
DRUG	Aromatase Inhibitor
DRUG	Growth Hormone
DRUG	Aromatase Inhibitor and Growth Hormone

Timeline

• Start date: 2010-11-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2010-11-25
• Last updated: 2018-08-07
• Results posted: 2018-06-07

Locations

4 sites across 2 countries: United States, Chile