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Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism

Primary Purpose

Hypothyroidism

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Growth hormone
Growth hormone treatment and puberty
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothyroidism focused on measuring Hypothyroidism, Growth hormone

Eligibility Criteria

8 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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. Moving to a location that the patient will not be able to be followed by a pediatric endocrinologist. Patient is not willing to continue with the study. -

Sites / Locations

  • Baylor college of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

1

2

3

Arm Description

Group 1 will be treated only with Synthroid.

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

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

Outcomes

Primary Outcome Measures

Final Height
The study was terminated due to insufficient funds. The study was terminated and the study PI has left the institution. All efforts to locate the study PI have been exhausted and the data is no longer available and cannot be reported.

Secondary Outcome Measures

Bone Age
The study was terminated due to insufficient funds. The study was terminated and the study PI has left the institution. All efforts to locate the study PI have been exhausted and the data is no longer available and cannot be reported.
Growth Factors
The study was terminated due to insufficient funds. The study was terminated and the study PI has left the institution. All efforts to locate the study PI have been exhausted and the data is no longer available and cannot be reported.

Full Information

First Posted
September 13, 2005
Last Updated
October 26, 2020
Sponsor
Baylor College of Medicine
Collaborators
Eli Lilly and Company, TAP Pharmaceutical Products Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00206375
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Study Start Date
May 2003 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Eli Lilly and Company, TAP Pharmaceutical Products Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism
Keywords
Hypothyroidism, Growth hormone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Group 1 will be treated only with Synthroid.
Arm Title
2
Arm Type
Experimental
Arm Description
Group 2 will be treated with Growth hormone, synthroid, and lupron.
Arm Title
3
Arm Type
No Intervention
Arm Description
Group 3 will have acute hypothyroidism and will serve as controls.
Intervention Type
Drug
Intervention Name(s)
Growth hormone
Other Intervention Name(s)
Humatrope
Intervention Description
Growth hormone + Synthroid + Lupron
Intervention Type
Drug
Intervention Name(s)
Growth hormone treatment and puberty
Other Intervention Name(s)
Humatrope
Intervention Description
Lupron once a month and growth hormone daily
Primary Outcome Measure Information:
Title
Final Height
Description
The study was terminated due to insufficient funds. The study was terminated and the study PI has left the institution. All efforts to locate the study PI have been exhausted and the data is no longer available and cannot be reported.
Time Frame
When bones are fused
Secondary Outcome Measure Information:
Title
Bone Age
Description
The study was terminated due to insufficient funds. The study was terminated and the study PI has left the institution. All efforts to locate the study PI have been exhausted and the data is no longer available and cannot be reported.
Time Frame
When bones are fused
Title
Growth Factors
Description
The study was terminated due to insufficient funds. The study was terminated and the study PI has left the institution. All efforts to locate the study PI have been exhausted and the data is no longer available and cannot be reported.
Time Frame
no time frame

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. Moving to a location that the patient will not be able to be followed by a pediatric endocrinologist. Patient is not willing to continue with the study. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parvin Yazdani, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor college of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism

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