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Epidemiology of Acromegaly in Denmark 1991-2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01752621
Recruitment Status : Unknown
Verified December 2014 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : December 19, 2012
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Aim: To assess the incidence rate, morbidity and mortality of acromegaly in Denmark.

Condition or disease
Acromegaly

Detailed Description:

Background: Acromegaly is a rare disease caused by GH hypersecretion from a pituitary adenoma. The annual incidence is estimated to be 3-5/million with a prevalence of 100 - 150/million. The incidence rate is however uncertain since no nationwide surveys exist. If left untreated or poorly controlled the condition is associated with progressive morbidity and an excess mortality. The primary treatment is surgery, which however only provides a cure rate of ≈ 50 -60% due to the size of the tumour. The second line treatment today is medical treatment with slow release formulations of somatostatin analogs (SA) and, more recently, a specific GH antagonist.

Accurate data on incidence rates and outcome of treatment are of obvious importance in order to provide optimal and evidence-based treatment for the disease. This is particularly relevant in light of the availability of new and effective treatment modalities such as the GH antagonist, the proper place of which in the treatment algorithm still remains controversial.

Denmark holds a unique position in terms of epidemiological studies due to the existence of well organized databases which include all its inhabitants. A recognised problem with epidemiological surveys from specialised centres is whether the figures are representative for the general population. A nationwide Danish study will profit from the fact that every Danish citizen holds a unique ID number that makes it easy to retrieve and combine pertinent data regarding health, disease and death from different registries. The investigators have previously used this for a landmark survey of another rare endocrine disease, i.e. Cushing's syndrome. This publication has been cited more than 100 times.

Aim: To assess the incidence rate, morbidity and mortality of acromegaly in Denmark.


Study Design

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Incidence and Late Prognosis of Acromegaly in Denmark From 1991 - 2010: Twenty Years of Medical Treatment
Study Start Date : February 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
acromegaly
patients with acromegaly
comparison population
matched background population


Outcome Measures

Primary Outcome Measures :
  1. Mortality of acromegaly [ Time Frame: 3 years ]
    Mortality and morbidity of acromegaly (MRR)


Secondary Outcome Measures :
  1. • Incidence of Acromegaly [ Time Frame: 3 years ]
    • Incidence of Acromegaly

  2. prevalence rates of Acromegaly [ Time Frame: 3 years ]
    prevalence rates of Acromegaly


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The entire danish population in the period 1991-2010 by means of national register
Criteria

Inclusion Criteria:

  • diagnosed with acromegaly in years 1991-2010
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752621


Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Jakob Dal
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Jens Otto Jorgensen, professor MEA AUH
More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01752621     History of Changes
Other Study ID Numbers: 3-3013-97/1/HKR
11-88-37-29 ( Other Identifier: data protection agency )
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014

Keywords provided by University of Aarhus:
Acromegaly
mortality
morbidity
incidence
prevalence

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases