Turner SyndromeNCT00443144
D3-GHR Polymorphism and Turner Syndrome
An observational study of Turner Syndrome and Short Stature, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The protein polymorphism of the growth hormone receptor characterized by the genomic deletion of exon 3 has been linked to the magnitude of the first-year-growth response to growth hormone (GH) in girls with Turner syndrome. Read more about this study
- Who is it for?
- Ages 38 months to 14 years, women only
- Conditions the study is for
- Turner Syndrome, Short Stature
- What is being tested?
- recombinant human growth hormone
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- May 2005to May 2007
- Phase
- Observational
- 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 38 months to 14 years
- Women only
- Child
Who may be able to join
- Turner syndrome defined by a structural aberration or lack of the X chromosome.
- Growth velocity less than 2 cm/year at the time of final analysis (= final height).
Who cannot join
- Age <3.5 or >14 years at start of GH therapy,
- GH peak serum levels < 8 ng/ml in two independent tests,
- Thelarche at start or during the first year of treatment,
- Oxandrolone therapy for any time and a duration of GH therapy less than 2 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: D3-Growth Hormone Receptor Polymorphism and Total Effect of Recombinant Human Growth Hormone on Growth in Girls With Turner Syndrome
The protein polymorphism of the growth hormone receptor characterized by the genomic deletion of exon 3 has been linked to the magnitude of the first-year-growth response to growth hormone (GH) in girls with Turner syndrome.
Objective: to study the long-term effect of GH therapy in Turner syndrome in correlation to this GHR polymorphism in a mainly retrospective design (chart-review).
- Conditions
- Turner Syndrome, Short Stature
- Being tested
- recombinant human growth hormone
- Keywords
- growth hormone receptor polymorphism, pharmacogenomics, growth promoting therapy
- Medical subject headings
- Turner Syndrome, Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human growth hormoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startMay 2005
- Primary completionApr 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Binder, University Hospital Tuebingen
- Investigators
- Gerhard Binder, M.D. PhD, Principal investigator, University-Children's Hospital Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443144
- Sponsor's protocol ID
- TS-TUE-FH1
- Status last verified
- Dec 2015
- First submitted
- 2 Mar 2007
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dos Santos C, Essioux L, Teinturier C, Tauber M, Goffin V, Bougneres P. A common polymorphism of the growth hormone receptor is associated with increased responsiveness to growth hormone. Nat Genet. 2004 Jul;36(7):720-4. doi: 10.1038/ng1379. Epub 2004 Jun 20.
PubMed 15208626
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D3-Growth Hormone Receptor Polymorphism and Total Effect of Recombinant Human Growth Hormone on Growth in Girls With Turner Syndrome
- ClinicalTrials.gov ID
- NCT00443144
- Acronym / sponsor ID
- TS-TUE-FH1
- Conditions
- Turner Syndrome, Short Stature
- Keywords
- growth hormone receptor polymorphism, pharmacogenomics, growth promoting therapy
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 5 Mar 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.
The protein polymorphism of the growth hormone receptor characterized by the genomic deletion of exon 3 has been linked to the magnitude of the first-year-growth response to growth hormone (GH) in girls with Turner syndrome.
Objective: to study the long-term effect of GH therapy in Turner syndrome in correlation to this GHR polymorphism in a mainly retrospective design (chart-review).
Study design
Who may qualify
- Ages
- 38 months to 14 years
- Sex
- Female only
- Age groups
- Child
Key inclusion criteria (2 listed)
- Turner syndrome defined by a structural aberration or lack of the X chromosome.
- Growth velocity less than 2 cm/year at the time of final analysis (= final height).
Key exclusion criteria (4 listed)
- Age <3.5 or >14 years at start of GH therapy,
- GH peak serum levels < 8 ng/ml in two independent tests,
- Thelarche at start or during the first year of treatment,
- Oxandrolone therapy for any time and a duration of GH therapy less than 2 years.
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 |
|---|---|---|
| recombinant human growth hormone | Drug | – |
Primary outcome
Not reported in the source record.
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 3 Dec 2015.
- Background: PubMed 15208626Dos Santos C, Essioux L, Teinturier C, Tauber M, Goffin V, Bougneres P. A common polymorphism of the growth hormone receptor is associated with increased responsiveness to growth hormone. Nat Genet. 2004 Jul;36(7):720-4. doi: 10.1038/ng1379. Epub 2004 Jun 20.
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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.
Gerhard Binder, M.D. PhD principal investigator
University-Children's Hospital Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Turner Syndrome and Short Stature, run by University Hospital Tuebingen at 1 site in Germany.
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 4 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 3 Dec 2015. 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 Germany. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00443144, which also lists 1 linked publication.
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 3 Dec 2015.