Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism
Recruitment status was Recruiting
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.
Drug: Growth hormone
Drug: Growth hormone treatment and puberty
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Concomitant Use of Growth Hormone and GnRH Agonist in Adolescent Patients With Acquired Hypothyroidism|
- final height [ Time Frame: When bones are fused ] [ Designated as safety issue: No ]
- bone age [ Time Frame: When bones are fused ] [ Designated as safety issue: No ]
- growth factors [ Time Frame: no time frame ] [ Designated as safety issue: No ]
|Study Start Date:||May 2003|
|Estimated Study Completion Date:||March 2012|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
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: HumatropeDrug: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206375
|Contact: Kimberly Mason, RNfirstname.lastname@example.org|
|United States, Texas|
|Baylor college of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Lori Malone 832-822-3784 email@example.com|
|Principal Investigator:||Parvin Yazdani, MD||Baylor College of Medicine|