Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism

NCT00206375 | Terminated Phase 4 Results DMC

• 1 other identifier: H-13213
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothyroidism

Keywords

Hypothyroidism; Growth hormone

Outcome Measures

Primary Outcomes (1)

• Final Height

  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.

  When bones are fused

Secondary Outcomes (2)

• Bone Age

  When bones are fused

• Growth Factors

  no time frame

Study Arms (3)

1

NO INTERVENTION

Group 1 will be treated only with Synthroid.

2

EXPERIMENTAL

Group 2 will be treated with Growth hormone, synthroid, and lupron.

Drug: Growth hormone; Drug: Growth hormone treatment and puberty

3

NO INTERVENTION

Group 3 will have acute hypothyroidism and will serve as controls.

Interventions

Growth hormone DRUG

Growth hormone + Synthroid + Lupron

Also known as: Humatrope

2

Growth hormone treatment and puberty DRUG

Lupron once a month and growth hormone daily

Also known as: Humatrope

2

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Eli Lilly and Company: collaborator
• TAP Pharmaceutical Products Inc.: collaborator

Study Sites (1)

Baylor college of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hypothyroidism

Interventions

Growth Hormone; Human Growth Hormone; Puberty

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Sexual Development

Results Point of Contact

• Title: Dr. MJ Redondo (designated by the institution to enter results)
• Organization: Texas Children's Hospital, Baylor College of Medicine

redondo@bcm.edu

832-822-1019

Study Officials

• Parvin Yazdani, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Unrelated to the study: Designated by institution to enter results (Study PI is not available)

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: May 1, 2003
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 30, 2020
• Results First Posted: October 30, 2020

Record last verified: 2020-10

Locations

US (1)