Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

N

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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