Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Hypopituitarism

In brief

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.

Key facts

Study ID

NCT00133354

Run by

Nemours Children's Clinic

People needed

53

Starts

2001-11-01

Expected to finish

2010-08-01

Last updated by the study team

2011-10-12

Who can join

Age: 11 and older, up to 18. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Nemours Children's Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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