Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys
Information source: Nemours Children's Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypopituitarism
Intervention: Arimidex (Anastrozole) (Drug); Placebo (Drug); Growth Hormone (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Nemours Children's Clinic Official(s) and/or principal investigator(s):
Nelly Mauras, MD, Principal Investigator, Affiliation: Nemours Children's Clinic
Summary
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.
Clinical Details
Official 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary outcome: The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement.
Secondary outcome: The secondary objective is to determine the effect of Arimidex® treatment in bone mineralization in pubertal GH deficient males treated concurrently with growth hormone.
Eligibility
Minimum age: 11 Years.
Maximum age: 18 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Nemours Children's Clinic, Jacksonville, Florida 32207, United States
Additional Information
Starting date: November 2001
Last updated: October 11, 2011
|
