Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism
Condition: Hypothyroidism
MeSH terms: Hypothyroidism
Intervention: Growth hormone; Growth hormone treatment and puberty
Intervention description: Growth hormone + Synthroid + Lupron; Lupron once a month and growth hormone daily
Intervention MeSH terms: Hormones
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hypothyroidism; Growth hormone

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. Females 8 to 16 years old.

          3. Males 9 to 17 years old.

          4. Patients without any chronic medical conditions.

          5. Availability of a parent or guardian to attend study visits with the patient and to be
             actively involved in the patient treatment plan.

          6. 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:

          1. Taking medications that affect their growth. (eg. Systemic corticosteroids, anabolic
             steroids)

          2. Experiencing other health problems/conditions that affect their growth rate such as
             growth hormone deficiency, Cushing Syndrome, rickets, and chronic diseases.

          3. 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.

          4. Moving to a location that the patient will not be able to be followed by a pediatric
             endocrinologist.

          5. Patient is not willing to continue with the study. -