Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00206375
Status:
TERMINATED
Last Update Posted:
2020-10-30
First Post:
2005-09-13
Brief Title:
Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Concomitant Use of Growth Hormone and GnRH Agonist in Adolescent Patients With Acquired Hypothyroidism
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None