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Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism

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ClinicalTrials.gov Identifier: NCT00206375
Recruitment Status : Terminated
First Posted : September 21, 2005
Results First Posted : October 30, 2020
Last Update Posted : October 30, 2020
Sponsor:
Collaborators:
Eli Lilly and Company
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
Maria Jose Redondo, Baylor College of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypothyroidism Drug: Growth hormone Drug: Growth hormone treatment and puberty Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Concomitant Use of Growth Hormone and GnRH Agonist in Adolescent Patients With Acquired Hypothyroidism
Study Start Date : May 2003
Actual Primary Completion Date : September 2011
Actual Study Completion Date : November 2011

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Final Height [ Time Frame: When bones are fused ]
    The study was terminated due to insufficient funds. The study was terminated and the study PI has left the institution. All efforts to locate the study PI have been exhausted and the data is no longer available and cannot be reported.


Secondary Outcome Measures :
  1. Bone Age [ Time Frame: When bones are fused ]
    The study was terminated due to insufficient funds. The study was terminated and the study PI has left the institution. All efforts to locate the study PI have been exhausted and the data is no longer available and cannot be reported.

  2. Growth Factors [ Time Frame: no time frame ]
    The study was terminated due to insufficient funds. The study was terminated and the study PI has left the institution. All efforts to locate the study PI have been exhausted and the data is no longer available and cannot be reported.


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00206375


Locations
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United States, Texas
Baylor college of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Eli Lilly and Company
TAP Pharmaceutical Products Inc.
Investigators
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Principal Investigator: Parvin Yazdani, MD Baylor College of Medicine
More Information
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Responsible Party: Maria Jose Redondo, Unrelated to the study: Designated by institution to enter results (Study PI is not available), Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00206375    
Other Study ID Numbers: H-13213
First Posted: September 21, 2005    Key Record Dates
Results First Posted: October 30, 2020
Last Update Posted: October 30, 2020
Last Verified: October 2020
Keywords provided by Maria Jose Redondo, Baylor College of Medicine:
Hypothyroidism
Growth hormone
Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs