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Epidemiology of Acromegaly

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01752621
First received: November 8, 2012
Last updated: February 24, 2014
Last verified: July 2013
  Purpose

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. It is well known that surgical cure may normalize mortality but similar data are not available for patients receiving medical treatment.

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 with a specific attention to a comparison between the outcome of surgery alone vs. medical treatment.


Condition
Acromegaly

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Mortality of acromegaly [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    Mortality and morbidity of acromegaly (MRR) with a special emphasis on:

    • Surgery alone vs. medical treatment with SA
    • Biochemical disease activity at last follow-up


Secondary Outcome Measures:
  • • Incidence of Acromegaly [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • Incidence of Acromegaly

  • prevalence rates of Acromegaly [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    prevalence rates of Acromegaly


Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgery treatment
acromegaly treated with surgery
medical treatment
acromegaly treated with somatostatin

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752621

Contacts
Contact: Jakob Dal, phd student +45 61394231 jakob.dal@dadlnet.dk

Locations
Denmark
Aarhus University Hospital Active, not recruiting
Aarhus, Denmark, 8000
Jakob Dal Recruiting
Aarhus, Denmark, 8000
Contact: Jakob Dal, phd student    0045-61394231    jakob.dal@ki.au.dk   
Principal Investigator: jakob dal, phd student         
Sponsors and Collaborators
University of Aarhus
  More Information

No publications provided

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
Study First Received: November 8, 2012
Last Updated: February 24, 2014
Health Authority: Denmark: Danish Health and Medicines Authority

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

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

ClinicalTrials.gov processed this record on November 25, 2014