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Completed

NCT Number: NCT00133354

Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

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.

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Key information

Conditions

Hypopituitarism Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Dwarfism, Pituitary Endocrine System Diseases Genetic Diseases, Inborn Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

11 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arimidex (Anastrozole)

Drug

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.

Placebo

Drug

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.

growth hormone

Drug

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.

Primary outcomes

  1. The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement.

    Time frame: 12months, 24months, 36months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • AstraZeneca
  • EMD Serono
  • Genentech, Inc.

Registry information

Official study title

Double-blind Trial Investigating the Safety and Efficacy of the Inhibitor Anastrozole (ARIMIDEX) in Delaying Epiphyseal Fusion and Increasing Height Potential of Adolescent Males With Growth Hormone (GH) Deficiency

Important dates

Study start
2001
Primary completion
2006
Study completion
2010
First posted
Aug 23, 2005
Registry last updated
Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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