A Phase 2/3 interventional study of Arimidex (Anastrozole) and Placebo in Hypopituitarism, sponsored by Nemours Children's Clinic. Completed at 1 site in United States. Open to male participants aged 11 Years to 18 Years. Per ClinicalTrials.gov, last updated 2011-10-12.
Sponsored by Nemours Children's Clinic · Phase 2/3 and Interventional
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.
43 studies on the registry are indexed under Hypopituitarism; 9 are open to participants now.
This study's enrollment of 53 is above the median of 35 across 23 interventional studies indexed under Hypopituitarism.
Browse Hypopituitarism studies →Nemours Children's Clinic is the lead sponsor of 130 studies on the registry; 27 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Drug: Arimidex (Anastrozole) · Drug: Growth Hormone
Drug: Placebo · Drug: Growth Hormone
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.
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.
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.
The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement.
Time frame: 12months, 24months, 36months
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
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Anastrozole