NCT01574859

Brief Summary

Retrospective trial of 300 patients with pituitary insufficiency treated in Department of Medica Endocrinology, Rigshospitalet, Copenhagen University concerning levothyroxine (T4) replacement and cardiovascular risk factors. The hypothesis is that subtle central hypothyroidism is associated with adverse cardiac risk factors, such as body composition and serum lipids, and that improved T4 replacement will eliminate this increased risk, independently of other pituitary hormone replacements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 2, 2013

Status Verified

March 1, 2013

Enrollment Period

7 months

First QC Date

April 7, 2012

Last Update Submit

March 30, 2013

Conditions

Hypopituitarism

Keywords

central hypothyroidismhypopituitarismlevothyroxine replacementlipidsbody composition

Outcome Measures

Primary Outcomes (1)

  • cholesterol

    March 2002 - March 2013

Study Arms (1)

hypopituitarism

group of patients with hypopituitarism

Other: levothyroxine

Interventions

levothyroxineOTHER

titration of T4 according to biochemical values

hypopituitarism

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients at Rigshospitalet treated for pituitary hypothyroidism in the years 1993 to 2008

You may qualify if:

  • All patients with pituitary hypopituitarism

You may not qualify if:

  • Unavailability of data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

HypopituitarismHypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Pituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Ulla Feldt-Rasmussen, Professor

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 7, 2012

First Posted

April 10, 2012

Study Start

April 1, 2012

Primary Completion

November 1, 2012

Study Completion

March 1, 2013

Last Updated

April 2, 2013

Record last verified: 2013-03

Locations

DK(1)