Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00206375
• Collaborator: Eli Lilly and Company (Industry), TAP Pharmaceutical Products Inc. (Industry)
• Enrollment: 16
• Location: 1
• Arms: 3
• Duration (Months): 102
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

• Study Type: Interventional
• 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 1, 2003
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

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 Names: Humatrope ; Drug: Growth hormone treatment and puberty; Lupron once a month and growth hormone daily; Other Names: Humatrope
No Intervention: 3 Group 3 will have acute hypothyroidism and will serve as controls.

Outcome Measures

Primary Outcome Measures

1. Final Height [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 [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 [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

Criteria

• Ages Eligible for Study: 8 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

• Principal Investigator: Parvin Yazdani, MD, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Sep 21, 2005
• Last Update Posted: Oct 30, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Maria Jose Redondo, Unrelated to the study: Designated by institution to enter results (Study PI is not available), Baylor College of Medicine: Hypothyroidism; Growth hormone
• Additional relevant MeSH terms: Hypothyroidism; Hormones

Study Results

Participant Flow

Arm/Group Title	Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro	Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa	Short Term Hypothyroidism, Treated With Thyroxine (Control 2)
Arm/Group Description	Group 1 will be treated only with Synthroid. Long term hypothyroidism, treated with thyroxine alone (control group)	Group 2 will be treated with Growth hormone, synthroid, and lupron. Growth hormone: Growth hormone + Synthroid + Lupron Growth hormone treatment and puberty: Lupron once a month and growth hormone daily. Long term hypothyroidism, treated with thyroxine, GH and GnRHa	Group 3 will have acute hypothyroidism and will serve as controls. Short term hypothyroidism, treated with thyroxine (control group)
Period Title: Overall Study
STARTED	6	3	7
COMPLETED	3	1	3
NOT COMPLETED	3	2	4

Baseline Characteristics

Arm/Group Title	Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro	Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa	Short Term Hypothyroidism, Treated With Thyroxine (Control 2)	Total
Arm/Group Description	Group 1 will be treated only with Synthroid. Long term hypothyroidism, treated with thyroxine alone (control group)	Group 2 will be treated with Growth hormone, synthroid, and lupron. Growth hormone: Growth hormone + Synthroid + Lupron Growth hormone treatment and puberty: Lupron once a month and growth hormone daily. Long term hypothyroidism, treated with thyroxine, GH and GnRHa	Group 3 will have acute hypothyroidism and will serve as controls. Short term hypothyroidism, treated with thyroxine (control group)	Total of all reporting groups
Overall Participants	6	3	7	16
Age (Count of Participants)
<=18 years	6 100%	3 100%	7 100%	16 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	5 83.3%	3 100%	7 100%	15 93.8%
Male	1 16.7%	0 0%	0 0%	1 6.3%
Race/Ethnicity, Customized (Count of Participants)
Non-Hispanic White	2 33.3%	2 66.7%	6 85.7%	10 62.5%
Hispanic	3 50%	1 33.3%	1 14.3%	5 31.3%
Black	0 0%	0 0%	0 0%	0 0%
Asian	1 16.7%	0 0%	0 0%	1 6.3%
Other	0 0%	0 0%	0 0%	0 0%
Height (cm) (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	124.5 (7.2)	121.3 (10.5)	142.3 (11.4)	131.7 (13.4)

Outcome Measures

1. Primary Outcome

Title	Final Height
Description	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.
Time Frame	When bones are fused

Outcome Measure Data

Analysis Population Description

n/a. 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

Arm/Group Title	Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro	Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa	Short Term Hypothyroidism, Treated With Thyroxine (Control 2)
Arm/Group Description	Group 1 will be treated only with Synthroid. Long term hypothyroidism, treated with thyroxine alone (control group)	Group 2 will be treated with Growth hormone, synthroid, and lupron. Growth hormone: Growth hormone + Synthroid + Lupron Growth hormone treatment and puberty: Lupron once a month and growth hormone daily. Long term hypothyroidism, treated with thyroxine, GH and GnRHa	Group 3 will have acute hypothyroidism and will serve as controls. Short term hypothyroidism, treated with thyroxine (control group)
Measure Participants	0	0	0

2. Secondary Outcome

Title	Bone Age
Description	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.
Time Frame	When bones are fused

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro	Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa	Short Term Hypothyroidism, Treated With Thyroxine (Control 2)
Arm/Group Description	Group 1 will be treated only with Synthroid. Long term hypothyroidism, treated with thyroxine alone (control group)	Group 2 will be treated with Growth hormone, synthroid, and lupron. Growth hormone: Growth hormone + Synthroid + Lupron Growth hormone treatment and puberty: Lupron once a month and growth hormone daily. Long term hypothyroidism, treated with thyroxine, GH and GnRHa	Group 3 will have acute hypothyroidism and will serve as controls. Short term hypothyroidism, treated with thyroxine (control group)
Measure Participants	0	0	0

3. Secondary Outcome

Title	Growth Factors
Description	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.
Time Frame	no time frame

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro	Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa	Short Term Hypothyroidism, Treated With Thyroxine (Control 2)
Arm/Group Description	Group 1 will be treated only with Synthroid. Long term hypothyroidism, treated with thyroxine alone (control group)	Group 2 will be treated with Growth hormone, synthroid, and lupron. Growth hormone: Growth hormone + Synthroid + Lupron Growth hormone treatment and puberty: Lupron once a month and growth hormone daily. Long term hypothyroidism, treated with thyroxine, GH and GnRHa	Group 3 will have acute hypothyroidism and will serve as controls. Short term hypothyroidism, treated with thyroxine (control group)
Measure Participants	0	0	0

Adverse Events

Arm/Group Title	Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro		Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa		Short Term Hypothyroidism, Treated With Thyroxine (Control 2)
Arm/Group Description	Group 1 will be treated only with Synthroid. Long term hypothyroidism, treated with thyroxine alone (control group)		Group 2 will be treated with Growth hormone, synthroid, and lupron. Growth hormone: Growth hormone + Synthroid + Lupron Growth hormone treatment and puberty: Lupron once a month and growth hormone daily. Long term hypothyroidism, treated with thyroxine, GH and GnRHa		Group 3 will have acute hypothyroidism and will serve as controls. Short term hypothyroidism, treated with thyroxine (control group)
All Cause Mortality
	Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro		Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa		Short Term Hypothyroidism, Treated With Thyroxine (Control 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro		Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa		Short Term Hypothyroidism, Treated With Thyroxine (Control 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/3 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro		Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa		Short Term Hypothyroidism, Treated With Thyroxine (Control 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/3 (0%)		0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.