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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
| TAP Pharmaceutical Products Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Group 1 will be treated only with Synthroid. | |
| 2 | Experimental | Group 2 will be treated with Growth hormone, synthroid, and lupron. |
|
| 3 | No Intervention | Group 3 will have acute hypothyroidism and will serve as controls. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Growth hormone | Drug | Growth hormone + Synthroid + Lupron |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | When bones are fused |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | When bones are fused |
| Growth Factors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parvin Yazdani, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor college of Medicine | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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 |
| FG002 | 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | When bones are fused |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. MJ Redondo (designated by the institution to enter results) | Texas Children's Hospital, Baylor College of Medicine | 832-822-1019 | redondo@bcm.edu |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D019382 | Human Growth Hormone |
| D011627 | Puberty |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Growth hormone treatment and puberty | Drug | Lupron once a month and growth hormone daily |
|
|
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. |
| no time frame |
| Study terminated due to lack of funds |
|
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 |
| BG002 | 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) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
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 |
| OG002 | 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) |
|
| 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. | 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 | Posted | When bones are fused |
|
|
| 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. | 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. | Posted | no time frame |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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 | 0 | 3 | 0 | 3 |
| EG002 | 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) | 0 | 7 | 0 | 7 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D046468 | Sexual Development |