Status:
COMPLETED
Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature
Lead Sponsor:
Nemours Children's Clinic
Collaborating Sponsors:
Thrasher Research Fund
Genentech, Inc.
Conditions:
Idiopathic Short Stature
Eligibility:
MALE
12-18 years
Phase:
PHASE3
Brief Summary
When treating very short children in puberty we are time-limited, as sex hormones cause the growth plates to fuse and growth to end. Growth Hormone (GH), plus drugs that stop puberty, increase height ...
Eligibility Criteria
Inclusion
- Males: Ages: 12 - less than 18 years.
- Bone age less than 14 ½ years at study initiation.
- Presence of puberty.
- Idiopathic short stature will be defined as a short child equal or less than -2SD for height, with normal GH responses to stimuli (\> or = 5ng/ml to at least 2 secretagogues) or a normal IGF-I and BP-3, normal body proportions and no other identifiable growth pathology.
- Accurate growth data for at least 6 months at baseline is available.
Exclusion
- Chronic illnesses.
- Chronic use of glucocorticosteroids.
- Previous use of hormonal treatment with AIs, sex steroids or GH in the preceding 6 months.
- Birth weight small for gestational age (SGA).
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01248416
Start Date
November 1 2010
End Date
September 1 2016
Last Update
August 7 2018
Active Locations (4)
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1
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
2
Nemours Children's Clinic
Orlando, Florida, United States, 32801
3
Nemours Children's Clinic- Jefferson
Philadelphia, Pennsylvania, United States, 19107
4
Veronica Mericq, MD
Santiago, Chile