HypothyroidismPhase 4NCT00206375
Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism
A Phase 4 study testing Growth hormone and Growth hormone treatment and puberty in people with Hypothyroidism, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Growth hormone and Growth hormone treatment and puberty
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Nov 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypothyroidism
- Being tested
- Growth hormone, Growth hormone treatment and puberty
- Keywords
- Hypothyroidism, Growth hormone
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth hormoneDrug
Also called Humatrope
Growth hormone + Synthroid + Lupron
Growth hormone treatment and pubertyDrug
Also called Humatrope
Lupron once a month and growth hormone daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Group 1 will be treated only with Synthroid. |
| 2 | Experimental | Group 2 will be treated with Growth hormone, synthroid, and lupron. Receives: Drug: Growth hormone; Drug: Growth hormone treatment and puberty |
| 3 | No intervention | Group 3 will have acute hypothyroidism and will serve as controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: When bones are fused
Secondary outcomes (2)
Bone Age
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.
Measured: When bones are fused
Growth Factors
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.
Measured: no time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2003
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, TAP Pharmaceutical Products Inc.
- Responsible party
- Principal investigator, Maria Jose Redondo, Baylor College of Medicine
- Investigators
- Parvin Yazdani, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206375
- Sponsor's protocol ID
- H-13213
- Status last verified
- Oct 2020
- First submitted
- 13 Sep 2005
- Last updated
- 30 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Use of Growth Hormone and GnRH Agonist in Adolescent Patients With Acquired Hypothyroidism
- ClinicalTrials.gov ID
- NCT00206375
- Acronym / sponsor ID
- H-13213
- Conditions
- Hypothyroidism
- Keywords
- Hypothyroidism, Growth hormone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, TAP Pharmaceutical Products Inc.
- Study start
- May 2003
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 30 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Group 1 will be treated only with Synthroid. |
| 2 | Experimental | Drug: Growth hormone, Drug: Growth hormone treatment and pubertyGroup 2 will be treated with Growth hormone, synthroid, and lupron. |
| 3 | No intervention | –Group 3 will have acute hypothyroidism and will serve as controls. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth hormoneAlso: HumatropeGrowth hormone + Synthroid + Lupron | Drug | 2 |
| Growth hormone treatment and pubertyAlso: HumatropeLupron once a month and growth hormone daily | Drug | 2 |
Primary outcome
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.
2 secondary outcomes
Bone Age
Time frame: When bones are fused
Growth Factors
Time frame: no time frame
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parvin Yazdani, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Growth hormone and Growth hormone treatment and puberty in people with Hypothyroidism, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final Height (time frame: When bones are fused). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.