Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

Nemours Children's Health

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hypopituitarism

Treatments: Drug: Placebo; Drug: Growth Hormone; Drug: Arimidex (Anastrozole)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00133354

M2372s

23381

IRUSANAS0008

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: Male

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

53 participants in 2 patient groups, including a placebo group

Arimidex and Growth Hormone

Active Comparator group

Treatment:

Drug: Arimidex (Anastrozole)

Drug: Growth Hormone

Placebo and Growth Hormone

Placebo Comparator group

Treatment:

Drug: Growth Hormone

Drug: Placebo