Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

Phase 2

Completed

• Conditions: Hypopituitarism
• Interventions: Drug: Arimidex (Anastrozole); Drug: Placebo; Drug: Growth Hormone

• Registration Number: NCT00133354
• Lead Sponsor: Nemours Children's Clinic

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 Description

Not available

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2005-08-19
• Study First Submitted QC: 2005-08-19
• Study First Posted: 2005-08-23
• Primary Completion: 2006-08
• Study Completion: 2010-08
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-11
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 53

Inclusion Criteria

• Growth hormone deficient by formal testing with two provocative agents.
• Treated with growth hormone for a minimum of 6 months prior to study entry.
• Growth hormone doses must be maintained at 0.2-0.4mg/kg/wk while in protocol.
• Stable organic pathology
• Presence of puberty [genital Tanner Stage > II (>4cc testicular volume)]
• Bone age (BA) > or = 11.5 years and < 15 years

Exclusion Criteria

• Participation in any other trial involving hormone therapy for at least 6 months prior.
• Chronic illnesses requiring long term medication that impair growth. (Stable patients with occasional asthma, patients on Ritalin or Adderall or patients on topical acne medication may be included).
• Hereditary disease diagnosed clinically.
• Moderate to severe scoliosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arimidex and Growth Hormone	Arimidex (Anastrozole)	-
Placebo and Growth Hormone	Placebo	-
Placebo and Growth Hormone	Growth Hormone	-
Arimidex and Growth Hormone	Growth Hormone	-

Primary Outcome Measures

Name	Time	Method
The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement.	12months, 24months, 36months

Secondary Outcome Measures

Name	Time	Method
The secondary objective is to determine the effect of Arimidex® treatment in bone mineralization in pubertal GH deficient males treated concurrently with growth hormone.	12months, 24months, 36months

Trial Locations

Locations (1)

Nemours Children's Clinic; 🇺🇸 Jacksonville, Florida, United States