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Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

Information source: Nemours Children's Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypopituitarism

Intervention: Arimidex (Anastrozole) (Drug); Placebo (Drug); Growth Hormone (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Nemours Children's Clinic

Official(s) and/or principal investigator(s):
Nelly Mauras, MD, Principal Investigator, Affiliation: Nemours Children's Clinic


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.

Clinical Details

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

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

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

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.


Minimum age: 11 Years. Maximum age: 18 Years. Gender(s): Male.


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


- 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.

Locations and Contacts

Nemours Children's Clinic, Jacksonville, Florida 32207, United States
Additional Information

Starting date: November 2001
Last updated: October 11, 2011

Page last updated: August 23, 2015

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