Status:
TERMINATED
Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Eli Lilly and Company
TAP Pharmaceutical Products Inc.
Conditions:
Hypothyroidism
Eligibility:
All Genders
8-17 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to see if giving growth hormone and Lupron along with thyroid hormone will improve final height in patients with long term hypothyroidism. Lupron is a medicine which is us...
Detailed Description
Hypothyroidism is often associated with growth failure. It takes several years for slow growth to be noticed. This growth retardation is typically severe and progressive. Thyroid hormone is necessary...
Eligibility Criteria
Inclusion
- Patients should have clinical and biochemical evidence of hypothyroidism, T4 less than 5.0 ng /dl , fT4 less than 1.0 mcg/dl and TSH of more than 10. Patients with prolonged hypothyroidism should have growth failure and delayed bone age of at least 2 SD from the mean. Patients with short term hypothyroidism should have normal growth velocity and bone age.
- Females 8 to 16 years old.
- Males 9 to 17 years old.
- Patients without any chronic medical conditions.
- Availability of a parent or guardian to attend study visits with the patient and to be actively involved in the patient treatment plan.
- Give written informed consent prior to any study specific screening procedure with the understanding that the patient has the right to withdraw from the study at any time without penalty.
Exclusion
- Taking medications that affect their growth. (eg. Systemic corticosteroids, anabolic steroids)
- Experiencing other health problems/conditions that affect their growth rate such as growth hormone deficiency, Cushing Syndrome, rickets, and chronic diseases.
- Patients with any condition that is a contraindication for GH therapy would include conditions such as an active tumor, impaired glucose tolerance, neurofibromatosis (worsening of neurofibromatosis), and hypertrophy of tonsils and adenoids with sleep apnea. Contraindications for patients for GNRHa therapy would include a severe systemic reaction to GNRHa which is rare, osteopenia, and osteoporosis, because delaying puberty will worsen the condition.
- Moving to a location that the patient will not be able to be followed by a pediatric endocrinologist.
- Patient is not willing to continue with the study. -
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00206375
Start Date
May 1 2003
End Date
November 1 2011
Last Update
October 30 2020
Active Locations (1)
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1
Baylor college of Medicine
Houston, Texas, United States, 77030