Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism

• Status: Terminated
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborators: Eli Lilly and Company; TAP Pharmaceutical Products Inc.
• Treatments: Deslorelin; Hormones

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. -