Epidemiology of Acromegaly in Denmark 1991-2010

NCT ID: NCT01752621

Last Updated: 2014-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Acromegaly

Keywords

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Acromegaly mortality morbidity incidence prevalence

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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acromegaly

patients with acromegaly

No interventions assigned to this group

comparison population

matched background population

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* diagnosed with acromegaly in years 1991-2010
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Otto Jorgensen, professor

Role: STUDY_DIRECTOR

MEA AUH

Locations

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Aarhus University Hospital

Aarhus, Aarhus, Denmark

Site Status

Jakob Dal

Aarhus, Aarhus, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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11-88-37-29

Identifier Type: OTHER

Identifier Source: secondary_id

3-3013-97/1/HKR

Identifier Type: -

Identifier Source: org_study_id