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Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism

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ClinicalTrials.gov Identifier: NCT00206375
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 22, 2015
Sponsor:
Collaborators:
Eli Lilly and Company
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
Baylor College of Medicine

September 13, 2005
September 21, 2005
September 22, 2015
May 2003
September 2011   (Final data collection date for primary outcome measure)
final height [ Time Frame: When bones are fused ]
final height
Complete list of historical versions of study NCT00206375 on ClinicalTrials.gov Archive Site
  • bone age [ Time Frame: When bones are fused ]
  • growth factors [ Time Frame: no time frame ]
  • bone age
  • growth factors
Not Provided
Not Provided
 
Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism
Concomitant Use of Growth Hormone and GnRH Agonist in Adolescent Patients With Acquired Hypothyroidism
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypothyroidism
  • 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: 1
    Group 1 will be treated only with Synthroid.
  • Experimental: 2
    Group 2 will be treated with Growth hormone, synthroid, and lupron.
    Interventions:
    • Drug: Growth hormone
    • Drug: Growth hormone treatment and puberty
  • No Intervention: 3
    Group 3 will have acute hypothyroidism and will serve as controls.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
20
November 2011
September 2011   (Final data collection date for primary outcome measure)

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. -
Sexes Eligible for Study: All
8 Years to 17 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00206375
H-13213
Yes
Not Provided
Not Provided
Baylor College of Medicine
Baylor College of Medicine
  • Eli Lilly and Company
  • TAP Pharmaceutical Products Inc.
Principal Investigator: Parvin Yazdani, MD Baylor College of Medicine
Baylor College of Medicine
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP