Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypopituitarism

Intervention / Treatment
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* Drug: Arimidex (Anastrozole)
* Drug: Placebo
* Drug: Growth Hormone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arimidex and Growth Hormone<br> | Drug: Arimidex (Anastrozole)<br>* 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.<br>Drug: Growth Hormone<br>* 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.<br>|
| Placebo Comparator: Placebo and Growth Hormone<br> | Drug: Placebo<br>* 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.<br>Drug: Growth Hormone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement. |  | 12months, 24months, 36months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Puberty, Growth hormone deficiency, aromatase inhibitors, estrogen, bone mineral density, short stature