Clinical Trials Directory

Trials / Terminated

TerminatedNCT00206375

Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism

Concomitant Use of Growth Hormone and GnRH Agonist in Adolescent Patients With Acquired Hypothyroidism

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
16 (actual)
Sponsor
Baylor College of Medicine · Academic / Other
Sex
All
Age
8 Years – 17 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGGrowth hormoneGrowth hormone + Synthroid + Lupron
DRUGGrowth hormone treatment and pubertyLupron once a month and growth hormone daily

Timeline

Start date
2003-05-01
Primary completion
2011-09-01
Completion
2011-11-01
First posted
2005-09-21
Last updated
2020-10-30
Results posted
2020-10-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00206375. Inclusion in this directory is not an endorsement.