Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Baylor College of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Eli Lilly and Company
TAP Pharmaceutical Products Inc.
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00206375
First received: September 13, 2005
Last updated: December 21, 2010
Last verified: December 2010
  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 4

Study Type: Interventional
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

Resource links provided by NLM:


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
No Intervention: 1
Group 1 will be treated only with Synthroid.
Experimental: 2
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.

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:

  1. 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.
  2. Females 8 to 16 years old.
  3. Males 9 to 17 years old.
  4. Patients without any chronic medical conditions.
  5. Availability of a parent or guardian to attend study visits with the patient and to be actively involved in the patient treatment plan.
  6. 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:

  1. Taking medications that affect their growth. (eg. Systemic corticosteroids, anabolic steroids)
  2. Experiencing other health problems/conditions that affect their growth rate such as growth hormone deficiency, Cushing Syndrome, rickets, and chronic diseases.
  3. 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.
  4. Moving to a location that the patient will not be able to be followed by a pediatric endocrinologist.
  5. Patient is not willing to continue with the study. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Parvin Yazdani, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00206375     History of Changes
Other Study ID Numbers: H-13213
Study First Received: September 13, 2005
Last Updated: December 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Hypothyroidism
Growth hormone

Additional relevant MeSH terms:
Hypothyroidism
Endocrine System Diseases
Thyroid Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014