Clinical Trial: Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Double-blind Trial Investigating the Safety and Efficacy of the Inhibitor Anastrozole (ARIMIDEX) in Delaying Epiphyseal Fusion and Increasing Height Potential of Adolescent Males With Growth Hormone (

Brief Summary: The purpose of this study is to see if Arimidex, an aromatase inhibitor, can delay epiphyseal fusion and increase predicted adult height in boys who are growth hormone deficient, in puberty, and who are taking growth hormone. This is a double blind, placebo controlled 3 year trial.

Detailed Summary:
Sponsor: Nemours Children's Clinic

Current Primary Outcome: The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement. [ Time Frame: 12months, 24months, 36months ]

Original Primary Outcome: The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement.

Current Secondary Outcome: The secondary objective is to determine the effect of Arimidex® treatment in bone mineralization in pubertal GH deficient males treated concurrently with growth hormone. [ Time Frame: 12months, 24months, 36months ]

Original Secondary Outcome: The secondary objective is to determine the effect of Arimidex® treatment in bone mineralization in pubertal GH deficient males treated concurrently with growth hormone.

Information By: Nemours Children's Clinic

Dates:
Date Received: August 19, 2005
Date Started: November 2001
Date Completion:
Last Updated: October 11, 2011
Last Verified: October 2011