Hypothyroidism
Conditions
Keywords
Hypothyroidism, Growth hormone
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.
Interventions
DRUGGrowth hormone
Growth hormone + Synthroid + Lupron
DRUGGrowth hormone treatment and puberty
Lupron once a month and growth hormone daily
Sponsors
Eli Lilly and Company
TAP Pharmaceutical Products Inc.
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Final Height | When bones are fused | 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
| Measure | Time frame | Description |
|---|---|---|
| Bone Age | When bones are fused | 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 | no time frame | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro Group 1 will be treated only with Synthroid. Long term hypothyroidism, treated with thyroxine alone (control group) | 6 |
| Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa Group 2 will be treated with Growth hormone, synthroid, and lupron.
Growth hormone: Growth hormone + Synthroid + Lupron
Growth hormone treatment and puberty: Lupron once a month and growth hormone daily.
Long term hypothyroidism, treated with thyroxine, GH and GnRHa | 3 |
| Short Term Hypothyroidism, Treated With Thyroxine (Control 2) Group 3 will have acute hypothyroidism and will serve as controls. Short term hypothyroidism, treated with thyroxine (control group) | 7 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Study terminated due to lack of funds | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 3 |
Baseline characteristics
| Characteristic | Short Term Hypothyroidism, Treated With Thyroxine (Control 2) | Total | Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro | Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa |
|---|---|---|---|---|
| Age, Categorical <=18 years | 7 Participants | 16 Participants | 6 Participants | 3 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height (cm) | 142.3 cm STANDARD_DEVIATION 11.4 | 131.7 cm STANDARD_DEVIATION 13.4 | 124.5 cm STANDARD_DEVIATION 7.2 | 121.3 cm STANDARD_DEVIATION 10.5 |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 5 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 6 Participants | 10 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 7 Participants | 15 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 3 | 0 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 3 | 0 / 7 |
Outcome results
Primary
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.
Time frame: When bones are fused
Population: n/a. 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
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.
Time frame: When bones are fused
Population: 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
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.
Time frame: no time frame
Population: 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.