AcromegalyNCT01752621
Epidemiology of Acromegaly in Denmark 1991-2010
An observational study of Acromegaly, run by University of Aarhus at 2 sites in Denmark.
Trial summary
Aim: To assess the incidence rate, morbidity and mortality of acromegaly in Denmark. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acromegaly
- How many people
- 500 participants
- Where
- 2 sitesDenmark
- Study dates
- Feb 2013to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The entire danish population in the period 1991-2010 by means of national register
Who may be able to join
- diagnosed with acromegaly in years 1991-2010
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital
Aarhus, Aarhus, 8000
Jakob Dal
Aarhus, Aarhus, 8000
About this study
Official title: Incidence and Late Prognosis of Acromegaly in Denmark From 1991 - 2010: Twenty Years of Medical Treatment
Aim: To assess the incidence rate, morbidity and mortality of acromegaly in Denmark.
Read the 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.
- Conditions
- Acromegaly
- Keywords
- Acromegaly, mortality, morbidity, incidence, prevalence
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| acromegaly | patients with acromegaly | |
| comparison population | matched background population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality of acromegaly
Mortality and morbidity of acromegaly (MRR)
Measured: 3 years
Secondary outcomes (2)
• Incidence of Acromegaly
- Incidence of Acromegaly
Measured: 3 years
prevalence rates of Acromegaly
prevalence rates of Acromegaly
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Otto Jorgensen, professor, Study director, MEA AUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752621
- Sponsor's protocol ID
- 3-3013-97/1/HKR
- Other IDs
- 11-88-37-29
- Status last verified
- Dec 2014
- First submitted
- 8 Nov 2012
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Late Prognosis of Acromegaly in Denmark From 1991 - 2010: Twenty Years of Medical Treatment
- ClinicalTrials.gov ID
- NCT01752621
- Acronym / sponsor ID
- 3-3013-97/1/HKR
- Conditions
- Acromegaly
- Keywords
- Acromegaly, mortality, morbidity, incidence, prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 19 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: To assess the incidence rate, morbidity and mortality of acromegaly in Denmark.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acromegaly | – | –patients with acromegaly |
| comparison population | – | –matched background population |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The entire danish population in the period 1991-2010 by means of national register
Key inclusion criteria (1 listed)
- diagnosed with acromegaly in years 1991-2010
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality of acromegaly
Time frame: 3 years
Mortality and morbidity of acromegaly (MRR)
2 secondary outcomes
• Incidence of Acromegaly
Time frame: 3 years
prevalence rates of Acromegaly
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Otto Jorgensen, professor study director
MEA AUH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality of acromegaly (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.