Status:
COMPLETED
Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys
Lead Sponsor:
Nemours Children's Clinic
Collaborating Sponsors:
AstraZeneca
Genentech, Inc.
Conditions:
Hypopituitarism
Eligibility:
MALE
11-18 years
Phase:
PHASE2
PHASE3
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00133354
Start Date
November 1 2001
End Date
August 1 2010
Last Update
October 12 2011
Active Locations (1)
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1
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207