Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism - Full Text View

Sponsors and Collaborators:	Baylor College of Medicine Eli Lilly and Company TAP Pharmaceutical Products Inc.
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00206375

Purpose

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.

Condition	Intervention	Phase
Hypothyroidism	Drug: Growth hormone Drug: Growth hormone treatment and puberty	Phase IV

Drug Information available for: Levothyroxine Sodium Thyroxine Leuprolide acetate Leuprolide Somatotropin Somatropin Gonadorelin Gonadorelin hydrochloride LH-RH

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Concomitant Use of Growth Hormone and GnRH Agonist in Adolescent Patients With Acquired Hypothyroidism

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

final height [ Time Frame: When bones are fused ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	21
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)

Arms	Assigned Interventions
1: No Intervention Synthroid alone
2: Experimental Growth hormone + synthroid + lupron	Drug: Growth hormone Growth hormone + Synthroid + Lupron Drug: Growth hormone treatment and puberty Lupron once a month and growth hormone daily
3: No Intervention Acute 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.

Eligibility

Ages Eligible for Study:	8 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients should have clinical and biochemical evidence of hypothyroidism, T4 less than 5.0 ng /dl , fT4 less than 1.0 mcg/dl and TSH of more than 10. Patients with prolonged hypothyroidism should have growth failure and delayed bone age of at least 2 SD from the mean. Patients with short term hypothyroidism should have normal growth velocity and bone age.
Females 8 to 16 years old.
Males 9 to 17 years old.
Patients without any chronic medical conditions.
Availability of a parent or guardian to attend study visits with the patient and to be actively involved in the patient treatment plan.
Give written informed consent prior to any study specific screening procedure with the understanding that the patient has the right to withdraw from the study at any time without penalty.

Exclusion Criteria:

Taking medications that affect their growth. (eg. Systemic corticosteroids, anabolic steroids)
Experiencing other health problems/conditions that affect their growth rate such as growth hormone deficiency, Cushing Syndrome, rickets, and chronic diseases.
Patients with any condition that is a contraindication for GH therapy would include conditions such as an active tumor, impaired glucose tolerance, neurofibromatosis (worsening of neurofibromatosis), and hypertrophy of tonsils and adenoids with sleep apnea. Contraindications for patients for GNRHa therapy would include a severe systemic reaction to GNRHa which is rare, osteopenia, and osteoporosis, because delaying puberty will worsen the condition.
Moving to a location that the patient will not be able to be followed by a pediatric endocrinologist.
Patient is not willing to continue with the study. -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206375

Contacts

Contact: Kimberly Mason, RN

832-822-1010

kjmason@bcm.tmc.edu

Locations

United States, Texas
Baylor college of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: Lori Malone 832-822-3784 lcmalone@texaschildrenshospital.org

Sponsors and Collaborators

Baylor College of Medicine

Eli Lilly and Company

TAP Pharmaceutical Products Inc.

Investigators

Principal Investigator:

Parvin Yazdani, MD

Baylor College of Medicine

More Information

Responsible Party:	Baylor College of Medicine ( Parvin Yazdani, MD )
Study ID Numbers:	H-13213
Study First Received:	September 13, 2005
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00206375
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

Hypothyroidism
Growth hormone

Study placed in the following topic categories:

Deslorelin
Leuprolide
Endocrine System Diseases

Hypothyroidism
Endocrinopathy
Thyroid Diseases

ClinicalTrials.gov processed this record on January 16, 2009