Traumatic Brain InjuryNCT01028742
Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity
An observational study of Traumatic Brain Injury and Hypopituitarism, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
The purpose of the study is to estimate the incidence of posttraumatic hypopituitarism, and to identify predisposing factors in order to establish a rational responsible socioeconomic screening program. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Hypopituitarism
- How many people
- 463 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Dec 2014
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients hospitalised with a traumatic brain injury at any danish hospital between 01.01.2008 - 31.12.2008
Who may be able to join
- International Classification of Diseases (ICD) 10 code S06.0-06.9
- Age 18 - 65 years at time of traumatic brain injury
- Duration of hospitalization > 24 hours.
Who cannot join
- Known pituitary disease
- Clinically significant liver or renal disease
- Breast-feeding
- Pregnancy
- Alcohol or drug abuse
About this study
The purpose of the study is to estimate the incidence of posttraumatic hypopituitarism, and to identify predisposing factors in order to establish a rational responsible socioeconomic screening program.
- Conditions
- Traumatic Brain Injury, Hypopituitarism
- Keywords
- Traumatic brain injury, Hypopituitarism, Incidence
- Medical subject headings
- Brain Injuries, Traumatic, Hypopituitarism
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypopituitarism
Measured: 5 years
Secondary outcomes (3)
Quality of life
Measured: 5 years
Fatigue
Measured: 5 years
Hypopituitary specific symptoms
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2014
- Study completionDec 2014
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 Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Aalborg University Hospital, Aarhus University Hospital
- Responsible party
- Principal investigator, Marianne Christina Klose, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ulla Feldt-Rasmussen, MD, Study chair, Dept of Endocrinology, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028742
- Sponsor's protocol ID
- H-B-2008-122
- Status last verified
- Dec 2014
- First submitted
- 8 Dec 2009
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Klose M, Stochholm K, Janukonyte J, Christensen LL, Cohen AS, Wagner A, Laurberg P, Christiansen JS, Andersen M, Feldt-Rasmussen U. Patient reported outcome in posttraumatic pituitary deficiency: results from The Danish National Study on posttraumatic hypopituitarism. Eur J Endocrinol. 2015 Jun;172(6):753-62. doi: 10.1530/EJE-14-1069. Epub 2015 Mar 12.
PubMed 25766045
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity
- ClinicalTrials.gov ID
- NCT01028742
- Acronym / sponsor ID
- H-B-2008-122
- Conditions
- Traumatic Brain Injury, Hypopituitarism
- Keywords
- Traumatic brain injury, Hypopituitarism, Incidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Odense University Hospital, Aalborg University Hospital, Aarhus University Hospital
- Study start
- Oct 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Dec 2009 (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 purpose of the study is to estimate the incidence of posttraumatic hypopituitarism, and to identify predisposing factors in order to establish a rational responsible socioeconomic screening program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalised with a traumatic brain injury at any danish hospital between 01.01.2008 - 31.12.2008
Key inclusion criteria (3 listed)
- International Classification of Diseases (ICD) 10 code S06.0-06.9
- Age 18 - 65 years at time of traumatic brain injury
- Duration of hospitalization > 24 hours.
Key exclusion criteria (5 listed)
- Known pituitary disease
- Clinically significant liver or renal disease
- Breast-feeding
- Pregnancy
- Alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hypopituitarism
Time frame: 5 years
3 secondary outcomes
Quality of life
Time frame: 5 years
Fatigue
Time frame: 5 years
Hypopituitary specific symptoms
Time frame: 5 years
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 4 Dec 2014.
- Derived from this study: PubMed 25766045Klose M, Stochholm K, Janukonyte J, Christensen LL, Cohen AS, Wagner A, Laurberg P, Christiansen JS, Andersen M, Feldt-Rasmussen U. Patient reported outcome in posttraumatic pituitary deficiency: results from The Danish National Study on posttraumatic hypopituitarism. Eur J Endocrinol. 2015 Jun;172(6):753-62. doi: 10.1530/EJE-14-1069. Epub 2015 Mar 12.
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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.
Ulla Feldt-Rasmussen, MD study chair
Dept of Endocrinology, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Hypopituitarism, run by Copenhagen University Hospital, Rigshospitalet.
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 3 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: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Hypopituitarism (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01028742, 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 4 Dec 2014; AzTrials last refreshed its copy on 28 Oct 2026.