NCT00133354

Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

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 (GH) Deficiency

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Nemours Children's Clinic · Academic / Other
• Sex: Male
• Age: 11 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypopituitarism

Interventions

Type	Name	Description
DRUG	Arimidex (Anastrozole)	Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH.
DRUG	Placebo	Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH.
DRUG	Growth Hormone	GH (Nutropin®, Genentech, So. San Francisco, CA) will be administered throughout the trial at a dose of \~0.3mg/kg.w (no more than 0.4mg/kg.w) given subcutaneously (SC) at bedtime daily. Dose adjustments on the GH dose will be made by the investigator at least every 6mo.

Timeline

• Start date: 2001-11-01
• Primary completion: 2006-08-01
• Completion: 2010-08-01
• First posted: 2005-08-23
• Last updated: 2011-10-12

Locations

1 site across 1 country: United States