Posttraumatic Hypopituitarism - Incidence, Predictors and... | NCT01028742

Studies
Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity

NCT01028742

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Dec 4, 2014Estimated

Enrollment

463Actual

Phase

Not provided

Conditions

Traumatic Brain Injury
Hypopituitarism

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Dec 8, 2009

First Submission Date that Met QC Criteria

Dec 8, 2009

First Posted Date

Dec 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2014

Last Update Posted Date

Dec 4, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marianne Christina Klose, MD, PhD, Rigshospitalet, DenmarkPrincipal Investigator

Lead Sponsor

Rigshospitalet, DenmarkOTHER

Collaborators

Name	Class
Odense University Hospital	OTHER
Aalborg University Hospital	OTHER
Aarhus University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

463Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hypopituitarism		5 years

Secondary Outcomes

Measure	Description	Time Frame
Quality of life		5 years
Fatigue		5 years
Hypopituitary specific symptoms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Known pituitary disease
Clinically significant liver or renal disease
Breast-feeding
Pregnancy
Alcohol or drug abuse

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulla Feldt-Rasmussen, MD	Dept of Endocrinology, Rigshospitalet	Study Chair

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25766045	Derived	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.

ID	Term
D000070642	Brain Injuries, Traumatic
D007018	Hypopituitarism

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases