Hypopituitarism
Conditions
Keywords
Puberty, Growth hormone deficiency, aromatase inhibitors, estrogen, bone mineral density, short stature
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.
Interventions
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.
DRUGPlacebo
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.
DRUGGrowth 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.
Sponsors
AstraZeneca
Genentech, Inc.
EMD Serono
Nemours Children's Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
11 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement. | 12months, 24months, 36months |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed