Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism (NCT00206375) | Clinical Trial Compass
TerminatedPhase 4
Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism
United States16 participantsStarted 2003-05
Plain-language 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 used to delay puberty and to prevent early closure of growing bones which might increase growth potential. Growth hormone is used to restore growth rate. This study will include children with "short term" and "long term" hypothyroidism.
Who can participate
Age range8 Years – 17 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.