Clinical trial NCT00206375: Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism
Official title: Concomitant Use of Growth Hormone and GnRH Agonist in Adolescent Patients With Acquired Hypothyroidism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypothyroidism
Keywords: Hypothyroidism
Growth hormone
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: TAP Pharmaceutical Products Inc.
First posted: 2005-09-21
Enrollment: 16
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 for normal growth. Treatment with thyroxine (thyroid hormone) results in rapid catch-up growth, which mostly happens during the first 18 months. Growth is accompanied by increased bone age, which means early fusion (closure of the growing bones) of the bones and reduced growth potential. For example, a patient, who is 10 years old but has bone age of 12 years, has growth potential of a 12 year old and will stop growing 2 years earlier than a 10 year old patient. According to the literature, prolonged juvenile hypothyroidism (low thyroid condition) resulted in a permanent loss in height and only 70% catch-up growth was generally achieved with thyroxine replacement.

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. -

Primary outcomes:
measure: Final Height
timeFrame: When bones are fused
Secondary outcomes:
measure: Bone Age
timeFrame: When bones are fused
measure: Growth Factors
timeFrame: no time frame
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor college of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Parvin Yazdani, MD
role: PRINCIPAL_INVESTIGATOR
References: