Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism
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|ClinicalTrials.gov Identifier: NCT00206375|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypothyroidism||Drug: Growth hormone Drug: Growth hormone treatment and puberty||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Concomitant Use of Growth Hormone and GnRH Agonist in Adolescent Patients With Acquired Hypothyroidism|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||November 2011|
No Intervention: 1
Group 1 will be treated only with Synthroid.
Group 2 will be treated with Growth hormone, synthroid, and lupron.
Drug: Growth hormone
Growth hormone + Synthroid + Lupron
Other Name: Humatrope
Drug: Growth hormone treatment and puberty
Lupron once a month and growth hormone daily
Other Name: Humatrope
No Intervention: 3
Group 3 will have acute hypothyroidism and will serve as controls.
- final height [ Time Frame: When bones are fused ]
- bone age [ Time Frame: When bones are fused ]
- growth factors [ Time Frame: no time frame ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00206375
|United States, Texas|
|Baylor college of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Parvin Yazdani, MD||Baylor College of Medicine|