AcromegalyNCT01000090
Surgical Versus Medical Treatment of Acromegaly
An observational study of Acromegaly, run by University of Aarhus at 1 site in Denmark.
Trial summary
Evaluate biochemical differences in acromegalic patients treated with surgery versus somatostatin analogues (SMS) (after surgery or alone). Hypothesis: Treatment modality exhibit different biochemical responses in acromegaly. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acromegaly
- How many people
- 63 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2009to Jun 2011
- 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: Acromegalic patients followed in the outpatient clinic at Århus University Hospital, Medical Department M
Who may be able to join
- Acromegaly diagnosis
- treated with Somatostatin analogues or surgery
- in treatment control
Who cannot join
- treatment with GH-antagonist
- never treated
- not in treatment control
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Versus Medical Treatment of Acromegaly: Effects on Biochemical Markers
Evaluate biochemical differences in acromegalic patients treated with surgery versus somatostatin analogues (SMS) (after surgery or alone).
Hypothesis: Treatment modality exhibit different biochemical responses in acromegaly.
- Conditions
- Acromegaly
- Keywords
- Acromegaly, Somatostatin analogues, Treatment
- 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, somatostain analogues | Not described | |
| Acromegaly patients, surgery | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2010
- Study completionJun 2011
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristine Z Rubeck, stud. med., Study director, Medical department M, Århus University HospitalJens Otto L Jørgensen, MD, Principal investigator, Medical department M, Århus University HospitalMichael Madsen, MD, Study director, Medical department M, Århus University HospitalSanne Fisker, MD, Study director, Medical department M, Århus University HospitalCaroline Adreasen, MD, Study director, Medical department M, Århus University HospitalJan Frystyk, MD, Study director, Medical department M, Århus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000090
- Sponsor's protocol ID
- kzr200809
- Status last verified
- Jun 2011
- First submitted
- 21 Oct 2009
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Versus Medical Treatment of Acromegaly: Effects on Biochemical Markers
- ClinicalTrials.gov ID
- NCT01000090
- Acronym / sponsor ID
- kzr200809
- Conditions
- Acromegaly
- Keywords
- Acromegaly, Somatostatin analogues, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Oct 2009 (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.
Evaluate biochemical differences in acromegalic patients treated with surgery versus somatostatin analogues (SMS) (after surgery or alone).
Hypothesis: Treatment modality exhibit different biochemical responses in acromegaly.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acromegaly patients, somatostain analogues | – | – |
| Acromegaly patients, surgery | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acromegalic patients followed in the outpatient clinic at Århus University Hospital, Medical Department M
Key inclusion criteria (3 listed)
- Acromegaly diagnosis
- treated with Somatostatin analogues or surgery
- in treatment control
Key exclusion criteria (3 listed)
- treatment with GH-antagonist
- never treated
- not in treatment control
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
Related trials for Acromegaly
RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
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.
Kristine Z Rubeck, stud. med. study director
Medical department M, Århus University Hospital
Jens Otto L Jørgensen, MD principal investigator
Medical department M, Århus University Hospital
Michael Madsen, MD study director
Medical department M, Århus University Hospital
1 site 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 1 site 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 3 Dec 2015.