Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism

NCT ID: NCT00206375

Last Updated: 2020-10-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2011-11-30

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.

Conditions

Hypothyroidism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group 1 will be treated only with Synthroid.

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

Group 2 will be treated with Growth hormone, synthroid, and lupron.

Group Type: EXPERIMENTAL

Growth hormone

Intervention Type: DRUG

Growth hormone + Synthroid + Lupron

Growth hormone treatment and puberty

Intervention Type: DRUG

Lupron once a month and growth hormone daily

3

Group 3 will have acute hypothyroidism and will serve as controls.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Growth hormone

Growth hormone + Synthroid + Lupron

Intervention Type: DRUG

Growth hormone treatment and puberty

Lupron once a month and growth hormone daily

Intervention Type: DRUG

Other Intervention Names

Humatrope; Humatrope

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. -

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

TAP Pharmaceutical Products Inc.

INDUSTRY

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Maria Jose Redondo

Unrelated to the study: Designated by institution to enter results (Study PI is not available)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Parvin Yazdani, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor college of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

H-13213

Identifier Type: -

Identifier Source: org_study_id