Trial · Interventional

TerminatedPhase 4Results postedRegistry data

Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism

NCTNCT00206375Other idH-13213

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

The registry gives no reason.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 16 participants (actual)
Sponsor: Baylor College of Medicine · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: May 2003
Primary completion: Sept 2011
Completion: Nov 2011
First posted: 21 Sept 2005 (estimated)
Last update posted: 30 Oct 2020
Conditions: Hypothyroidism

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20042006200820102012

Ph 4
Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism
NCT00206375
May 2003 to Nov 2011
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Growth hormoneDrug
Growth hormone treatment and pubertyDrug

Arms3

No intervention
1
Group 1 will be treated only with Synthroid.
Experimental
2
Group 2 will be treated with Growth hormone, synthroid, and lupron.
No intervention
3
Group 3 will have acute hypothyroidism and will serve as controls.

Primary outcomes1

Outcomes the sponsor listed as primary.

Final Height
Time frame · When bones are fused
Registry 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.

Secondary outcomes(2)

Bone Age
Time frame · When bones are fused
Registry 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.
Growth Factors
Time frame · no time frame
Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· When bones are fused

Final Height

Group	Value
Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro	not posted
Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa	not posted
Short Term Hypothyroidism, Treated With Thyroxine (Control 2)	not posted

Secondary and other outcome results(2)

Secondary outcome· When bones are fused

Bone Age

Group	Value
Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro	not posted
Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa	not posted
Short Term Hypothyroidism, Treated With Thyroxine (Control 2)	not posted

Secondary outcome· no time frame

Growth Factors

Group	Value
Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro	not posted
Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa	not posted
Short Term Hypothyroidism, Treated With Thyroxine (Control 2)	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Long Term Hypothyroidism, Treated With Thyroxine Alone (ControGroup 1 will be treated only with Synthroid. Long term hypothyroidism, treated with thyroxine alone (control group)	–	0 / 6	0 / 6
Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHaGroup 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	–	0 / 3	0 / 3
Short Term Hypothyroidism, Treated With Thyroxine (Control 2)Group 3 will have acute hypothyroidism and will serve as controls. Short term hypothyroidism, treated with thyroxine (control group)	–	0 / 7	0 / 7

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 8 Years up to 17 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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. -

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