NCT01184209

Brief Summary

Prospective study to evaluate incidence, causes and potential risk factors for adrenal crisis in patients with chronic adrenal insufficiency.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
444

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 6, 2014

Status Verified

January 1, 2014

Enrollment Period

4.5 years

First QC Date

August 17, 2010

Last Update Submit

January 3, 2014

Conditions

Adrenal Insufficiency

Outcome Measures

Primary Outcomes (1)

  • incidence of adrenal crisis

    during study period

Secondary Outcomes (1)

  • mortality

    during study period

Other Outcomes (1)

  • hospital admission

    during study period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult patients with chronic secondary or primary adrenal failure

You may qualify if:

  • chronic primary or secondary adrenal insufficiency requiring glucocorticoid substitution therapy

You may not qualify if:

  • adrenocortical carcinoma
  • long term glucocorticoid treatment above 7.5 mg prednisone equivalent dose for other reasons than adrenal insufficiency
  • age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Berlin

Berlin, D-10117, Germany

Location

University of Wuerzburg

Würzburg, D-97080, Germany

Location

Related Publications (1)

  • Hahner S, Spinnler C, Fassnacht M, Burger-Stritt S, Lang K, Milovanovic D, Beuschlein F, Willenberg HS, Quinkler M, Allolio B. High incidence of adrenal crisis in educated patients with chronic adrenal insufficiency: a prospective study. J Clin Endocrinol Metab. 2015 Feb;100(2):407-16. doi: 10.1210/jc.2014-3191. Epub 2014 Nov 24.

    PMID: 25419882DERIVED

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Bruno Allolio, MD

    University of Wuerzburg

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 18, 2010

Study Start

February 1, 2007

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 6, 2014

Record last verified: 2014-01

Locations

DE(2)