Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target
Primary Purpose
Acromegaly
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Sandostatin® LAR
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly, Somatostatin analogs, Treatment
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Age > 18 years
- Capable and of age
- Diagnosed with acromegaly
- Sufficient treated for at least 6 months prior to enrollment
Exclusion Criteria:
- Pregnancy or nursing
- Any disease that may compromise the ability to comply with the protocol, as assessed by the investigator
Sites / Locations
- Department of Endocrinology, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
SA monitored by GH
SA monitored by IGF-I
Control
Arm Description
Control, patients who have achieved sufficient disease control by surgery alone.
Outcomes
Primary Outcome Measures
Change in Quality of Life
AcroQol (Acromegaly Quality of Life Questionnaire) and PASQ (Patient-Assessed Acromegaly Symptom Questionnaire)
Secondary Outcome Measures
SA dosage
SA dosage at last follow-up
Change in glucose, FFA and insulin
Glucose tolerance during an oral glucose load of 75 gram of glucose
Change in discordant GH/IGF-I levels
Discordant GH/IGF-I levels are recorded.
New biomarkers of treatment evaluation
New biomarkers of GH/IGF-I status (bioactive IGF-I)
New biomarkers of treatment evaluation2
New biomarkers of GH/IGF-I status (free GH)
Full Information
NCT ID
NCT01618513
First Posted
June 4, 2012
Last Updated
January 25, 2017
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Odense University Hospital, Herlev Hospital, Copenhagen University Hospital, Denmark, Aalborg University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01618513
Brief Title
Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target
Official Title
Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Odense University Hospital, Herlev Hospital, Copenhagen University Hospital, Denmark, Aalborg University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly, Somatostatin analogs, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SA monitored by GH
Arm Type
Experimental
Arm Title
SA monitored by IGF-I
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control, patients who have achieved sufficient disease control by surgery alone.
Intervention Type
Drug
Intervention Name(s)
Sandostatin® LAR
Intervention Description
Intramuscular injections, dosage based on either GH or IGF-I levels.
Primary Outcome Measure Information:
Title
Change in Quality of Life
Description
AcroQol (Acromegaly Quality of Life Questionnaire) and PASQ (Patient-Assessed Acromegaly Symptom Questionnaire)
Time Frame
Baseline and after 12 months
Secondary Outcome Measure Information:
Title
SA dosage
Description
SA dosage at last follow-up
Time Frame
After 12 months of treatment
Title
Change in glucose, FFA and insulin
Description
Glucose tolerance during an oral glucose load of 75 gram of glucose
Time Frame
Baseline and after 12 months
Title
Change in discordant GH/IGF-I levels
Description
Discordant GH/IGF-I levels are recorded.
Time Frame
Baseline and after 12 months
Title
New biomarkers of treatment evaluation
Description
New biomarkers of GH/IGF-I status (bioactive IGF-I)
Time Frame
Baseline and after 12 months
Title
New biomarkers of treatment evaluation2
Description
New biomarkers of GH/IGF-I status (free GH)
Time Frame
Baseline and after 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Age > 18 years
Capable and of age
Diagnosed with acromegaly
Sufficient treated for at least 6 months prior to enrollment
Exclusion Criteria:
Pregnancy or nursing
Any disease that may compromise the ability to comply with the protocol, as assessed by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Otto L. Jørgensen, Professor
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Endocrinology, Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target
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