Turner SyndromeNCT00420654
Growth Hormone Treatment of Women With Turner Syndrome
A study testing Growth Hormone in people with Turner Syndrome, run by Britta E. Hjerrild at 1 site in Denmark.
Trial summary
Growth hormone treatment is used in girls with Turner syndrome to increase final height. The aim of this study is to evaluate the effect of growth hormone treatment on body composition and heart function in adult women with Turner syndrome. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Turner Syndrome
- What is being tested?
- Growth Hormone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2007to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Turner syndrome
- Age 20-40
Who cannot join
- Symptomatic heart disease
- Anti hypertensive treatment
- Untreated thyroid disease
- Adipositas (BMI > 35)
- Treatment with glucocorticoids
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital
Aarhus, DK, 8000
About this study
Official title: Growth Hormone Treatment of Women With Turner Syndrome: Body Composition and Heart Function.
Growth hormone treatment is used in girls with Turner syndrome to increase final height. The aim of this study is to evaluate the effect of growth hormone treatment on body composition and heart function in adult women with Turner syndrome. The hypothesis is that the fat mass will decrease and lean body mass will increase. There is only very limited documentation of the effect on the heart in this study population.
Read the detailed description
This study is a randomised, double-blinded, controlled clinical trial to evaluate the effect of growth hormone (GH) treatment on adult women with Turner syndrome. The endpoints will be changes in body composition and heart function evaluated by echocardiography (ECHO) and positron emission tomography (PET).
Phase one: 6 months of GH or placebo treatment. Phase two: "open label" all participants are treated with GH for 12 months. At baseline, healthy controls will be examined, but will not receive any treatment
- Conditions
- Turner Syndrome
- Being tested
- Growth Hormone, Placebo, Healthy controls
- Keywords
- Turner syndrome, growth hormone treatment, positron emission tomography, heart
- Medical subject headings
- Turner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth HormoneDrug
1.25 mg, 6 months
PlaceboDrug
Equivalent to 1.25 mg, 6 months
Healthy controlsOther
Healthy controls
| Study group | Role | What they receive |
|---|---|---|
| A1 | Active comparator | Not described Receives: Drug: Growth Hormone |
| A2 | Placebo comparator | Not described Receives: Drug: Placebo |
| A3 | Other | Not described Receives: Other: Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition: fat mass and lean body mass
Measured: 6 months + 18 months
Myocardial perfusion and glucose uptake, evaluated by positron emission tomography
Measured: 6 months
Secondary outcomes (3)
Heart function evaluated by echocardiography (conventional and tissue doppler)
Measured: 6 months + 18 months
Lipid profile
Measured: 6 months + 18 months
24 hour ambulatory blood pressure
Measured: 6 months + 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startAug 2007
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Turner SyndromeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Britta E. Hjerrild
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Britta E. Hjerrild, University of Aarhus
- Investigators
- Jens S. Christiansen, prof. dr.med, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420654
- Sponsor's protocol ID
- 2005-BH-GH
- Status last verified
- Nov 2011
- First submitted
- 10 Jan 2007
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone Treatment of Women With Turner Syndrome: Body Composition and Heart Function.
- ClinicalTrials.gov ID
- NCT00420654
- Acronym / sponsor ID
- 2005-BH-GH
- Conditions
- Turner Syndrome
- Keywords
- Turner syndrome, growth hormone treatment, positron emission tomography, heart
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Britta E. HjerrildUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Growth hormone treatment is used in girls with Turner syndrome to increase final height. The aim of this study is to evaluate the effect of growth hormone treatment on body composition and heart function in adult women with Turner syndrome. The hypothesis is that the fat mass will decrease and lean body mass will increase. There is only very limited documentation of the effect on the heart in this study population.
Detailed description
This study is a randomised, double-blinded, controlled clinical trial to evaluate the effect of growth hormone (GH) treatment on adult women with Turner syndrome. The endpoints will be changes in body composition and heart function evaluated by echocardiography (ECHO) and positron emission tomography (PET).
Phase one: 6 months of GH or placebo treatment. Phase two: "open label" all participants are treated with GH for 12 months. At baseline, healthy controls will be examined, but will not receive any treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A1 | Active comparator | Drug: Growth Hormone |
| A2 | Placebo comparator | Drug: Placebo |
| A3 | Other | Other: Healthy controls |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Turner syndrome
- Age 20-40
Key exclusion criteria (6 listed)
- Symptomatic heart disease
- Anti hypertensive treatment
- Untreated thyroid disease
- Adipositas (BMI > 35)
- Treatment with glucocorticoids
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 Hormone1.25 mg, 6 months | Drug | A1 |
| PlaceboEquivalent to 1.25 mg, 6 months | Drug | A2 |
| Healthy controlsHealthy controls | Other | A3 |
Primary outcome
Body composition: fat mass and lean body mass
Time frame: 6 months + 18 months
Myocardial perfusion and glucose uptake, evaluated by positron emission tomography
Time frame: 6 months
3 secondary outcomes
Heart function evaluated by echocardiography (conventional and tissue doppler)
Time frame: 6 months + 18 months
Lipid profile
Time frame: 6 months + 18 months
24 hour ambulatory blood pressure
Time frame: 6 months + 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
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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.
Jens S. Christiansen, prof. dr.med principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth Hormone in people with Turner Syndrome, run by Britta E. Hjerrild at 1 site in Denmark.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 8 Nov 2011. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body composition: fat mass and lean body mass (time frame: 6 months + 18 months). The study lists 2 primary outcomes in all. 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 8 Nov 2011.