Epidemiology of Acromegaly in Denmark 1991-2010

Acromegaly Clinical Trial

Official title:

Incidence and Late Prognosis of Acromegaly in Denmark From 1991 - 2010: Twenty Years of Medical Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01752621
• Other study ID #: 3-3013-97/1/HKR
• Secondary ID: 11-88-37-29
• Status: Active, not recruiting
• Phase: N/A
• First received: November 8, 2012
• Last updated: December 5, 2014
• Start date: February 2013
• Est. completion date: March 2015

Study information

• Verified date: December 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosed with acromegaly in years 1991-2010

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acromegaly

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Jakob Dal	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality of acromegaly	Mortality and morbidity of acromegaly (MRR)	3 years	No
Secondary	• Incidence of Acromegaly	• Incidence of Acromegaly	3 years	No
Secondary	prevalence rates of Acromegaly	prevalence rates of Acromegaly	3 years	No