ClinicalTrials.gg
CompletedNCT01028742Updated Dec 4, 2014

Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity

An observational study in Traumatic Brain Injury and Hypopituitarism, sponsored by Rigshospitalet, Denmark. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-04.

Sponsored by Rigshospitalet, Denmark · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
463
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Traumatic Brain Injury
  • Hypopituitarism

Keywords

  • Traumatic brain injury
  • Hypopituitarism
  • Incidence
03

In context

Brain Injuries, Traumatic

1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.

This study's enrollment of 463 is above the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.

Browse Brain Injuries, Traumatic studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients hospitalised with a traumatic brain injury at any danish hospital between 01.01.2008 - 31.12.2008

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Known pituitary disease
  • liver or renal disease
  • Breast-feeding
  • Pregnancy
  • Alcohol or drug abuse
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
463 participants (actual)
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Hypopituitarism

    Time frame: 5 years

Secondary outcomes

  1. Quality of life

    Time frame: 5 years

  2. Fatigue

    Time frame: 5 years

  3. Hypopituitary specific symptoms

    Time frame: 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2009, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2009
First posted
Dec 9, 2009
Start
Oct 2009
Primary completionActual
Dec 2014
CompletionActual
Dec 2014
Last update
Dec 4, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01028742
Responsible party
Marianne Christina Klose (MD, PhD, Rigshospitalet, Denmark) — Principal investigator
First posted
Dec 9, 2009
Start date
Oct 2009
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Dec 4, 2014

Study contacts

Ulla Feldt-Rasmussen, MD
study chair · Dept of Endocrinology, Rigshospitalet

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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