NCT01000090

Brief Summary

Evaluate biochemical differences in acromegalic patients treated with surgery versus somatostatin analogues (SMS) (after surgery or alone). Hypothesis: Treatment modality exhibit different biochemical responses in acromegaly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 3, 2015

Status Verified

June 1, 2011

Enrollment Period

4 months

First QC Date

October 21, 2009

Last Update Submit

December 2, 2015

Conditions

Acromegaly

Keywords

AcromegalySomatostatin analoguesTreatment

Study Arms (2)

Acromegaly patients, somatostain analogues

Acromegaly patients, surgery

Eligibility Criteria

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

Acromegalic patients followed in the outpatient clinic at Århus University Hospital, Medical Department M

You may qualify if:

  • Acromegaly diagnosis
  • treated with Somatostatin analogues or surgery
  • in treatment control

You may not qualify if:

  • treatment with GH-antagonist
  • never treated
  • not in treatment control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Århus University Hospital, Medical department M

Aarhus, 8000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Kristine Z Rubeck, stud. med.

    Medical department M, Århus University Hospital

    STUDY DIRECTOR

  • Jens Otto L Jørgensen, MD

    Medical department M, Århus University Hospital

    PRINCIPAL INVESTIGATOR

  • Michael Madsen, MD

    Medical department M, Århus University Hospital

    STUDY DIRECTOR

  • Sanne Fisker, MD

    Medical department M, Århus University Hospital

    STUDY DIRECTOR

  • Caroline Adreasen, MD

    Medical department M, Århus University Hospital

    STUDY DIRECTOR

  • Jan Frystyk, MD

    Medical department M, Århus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 22, 2009

Study Start

October 1, 2009

Primary Completion

February 1, 2010

Study Completion

June 1, 2011

Last Updated

December 3, 2015

Record last verified: 2011-06

Locations

DK(1)