AcromegalyPhase 4NCT01618513
Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target
A Phase 4 study testing Sandostatin® LAR in people with Acromegaly, run by University of Aarhus at 1 site in Denmark.
Trial summary
Treatment of acromegaly with somatostatin analogs (SA) is well-established and are primarily used after insufficient surgical intervention, but also as primary medical treatment in selected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Sandostatin® LAR
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2012to Jan 2017
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age > 18 years
- Capable and of age
- Diagnosed with acromegaly
- Sufficient treated for at least 6 months prior to enrollment
Who cannot join
- Pregnancy or nursing
- Any disease that may compromise the ability to comply with the protocol, as assessed by the investigator
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology, Aarhus University Hospital
Aarhus C, 8000
About this study
Treatment of acromegaly with somatostatin analogs (SA) is well-established and are primarily used after insufficient surgical intervention, but also as primary medical treatment in selected patients. Evaluation of treatment control is based on monitoring blood levels of growth hormone (GH) and insulin-like growth factor-I (IGF-I). However, evaluation of disease control during SA treatment is not always straightforward. It is usually based on normalization of IGF-I and achievement of a certain GH level. In approximately 40% of patients discordant values of GH and IGF-I levels are seen after treatment with SA, with normalized IGF-I levels, despite elevated GH levels. The mechanism behind this observation is unknown, but it indicates that SA may affect this difference.
The primary objective of this study is to investigate if disease control during SA treatment is best achieved by monitoring either GH or IGF-I.
- Conditions
- Acromegaly
- Being tested
- Sandostatin® LAR
- Keywords
- Acromegaly, Somatostatin analogs, Treatment
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sandostatin® LARDrug
Intramuscular injections, dosage based on either GH or IGF-I levels.
| Study group | Role | What they receive |
|---|---|---|
| SA monitored by GH | Experimental | Not described Receives: Drug: Sandostatin® LAR |
| SA monitored by IGF-I | Experimental | Not described Receives: Drug: Sandostatin® LAR |
| Control | No intervention | Control, patients who have achieved sufficient disease control by surgery alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life
AcroQol (Acromegaly Quality of Life Questionnaire) and PASQ (Patient-Assessed Acromegaly Symptom Questionnaire)
Measured: Baseline and after 12 months
Secondary outcomes (5)
SA dosage
SA dosage at last follow-up
Measured: After 12 months of treatment
Change in glucose, FFA and insulin
Glucose tolerance during an oral glucose load of 75 gram of glucose
Measured: Baseline and after 12 months
Change in discordant GH/IGF-I levels
Discordant GH/IGF-I levels are recorded.
Measured: Baseline and after 12 months
New biomarkers of treatment evaluation
New biomarkers of GH/IGF-I status (bioactive IGF-I)
Measured: Baseline and after 12 months
New biomarkers of treatment evaluation2
New biomarkers of GH/IGF-I status (free GH)
Measured: Baseline and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2017
- Study completionJan 2017
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Herlev Hospital, Copenhagen University Hospital, Denmark, Aalborg University Hospital
- Responsible party
- Sponsor
- Investigators
- Jens Otto L. Jørgensen, Professor, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618513
- Sponsor's protocol ID
- SOM-2012-01
- Status last verified
- Dec 2014
- First submitted
- 4 Jun 2012
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target
- ClinicalTrials.gov ID
- NCT01618513
- Acronym / sponsor ID
- SOM-2012-01
- Conditions
- Acromegaly
- Keywords
- Acromegaly, Somatostatin analogs, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Herlev Hospital, Copenhagen University Hospital, Denmark, Aalborg University Hospital
- Study start
- Jun 2012 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Jun 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.
Treatment of acromegaly with somatostatin analogs (SA) is well-established and are primarily used after insufficient surgical intervention, but also as primary medical treatment in selected patients. Evaluation of treatment control is based on monitoring blood levels of growth hormone (GH) and insulin-like growth factor-I (IGF-I). However, evaluation of disease control during SA treatment is not always straightforward. It is usually based on normalization of IGF-I and achievement of a certain GH level. In approximately 40% of patients discordant values of GH and IGF-I levels are seen after treatment with SA, with normalized IGF-I levels, despite elevated GH levels. The mechanism behind this observation is unknown, but it indicates that SA may affect this difference.
The primary objective of this study is to investigate if disease control during SA treatment is best achieved by monitoring either GH or IGF-I.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SA monitored by GH | Experimental | Drug: Sandostatin® LAR |
| SA monitored by IGF-I | Experimental | Drug: Sandostatin® LAR |
| Control | No intervention | –Control, patients who have achieved sufficient disease control by surgery alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent
- Age > 18 years
- Capable and of age
- Diagnosed with acromegaly
- Sufficient treated for at least 6 months prior to enrollment
Key exclusion criteria (2 listed)
- Pregnancy or nursing
- Any disease that may compromise the ability to comply with the protocol, as assessed by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sandostatin® LARIntramuscular injections, dosage based on either GH or IGF-I levels. | Drug | SA monitored by GH, SA monitored by IGF-I |
Primary outcome
Change in Quality of Life
Time frame: Baseline and after 12 months
AcroQol (Acromegaly Quality of Life Questionnaire) and PASQ (Patient-Assessed Acromegaly Symptom Questionnaire)
5 secondary outcomes
SA dosage
Time frame: After 12 months of treatment
Change in glucose, FFA and insulin
Time frame: Baseline and after 12 months
Change in discordant GH/IGF-I levels
Time frame: Baseline and after 12 months
New biomarkers of treatment evaluation
Time frame: Baseline and after 12 months
New biomarkers of treatment evaluation2
Time frame: Baseline and after 12 months
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 26 Jan 2017.
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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 L. Jørgensen, Professor study chair
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sandostatin® LAR in people with 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 5 inclusion and 2 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 26 Jan 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Change in Quality of Life (time frame: Baseline and after 12 months). 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 26 Jan 2017.