Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

Hypopituitarism Clinical Trial

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 (GH) Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133354
• Other study ID #: IRUSANAS0008
• Secondary ID: M2372s23381
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 19, 2005
• Last updated: October 11, 2011
• Start date: November 2001
• Est. completion date: August 2010

Study information

• Verified date: October 2011
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 2010
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 11 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Hypopituitarism

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Nemours Children's Clinic	Jacksonville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Nemours Children's Clinic	AstraZeneca, EMD Serono, Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement.		12months, 24months, 36months	No
Secondary	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	Yes