Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

Nemours Children's Clinic53 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Hypopituitarism

Interventions

Arimidex (Anastrozole)DRUG

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.

PlaceboDRUG

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 HormoneDRUG

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.

Eligibility

Sex: MALEMin age: 11 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Nemours Children's Clinic

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: 12months, 24months, 36months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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