Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target

January 25, 2017 updated by: University of Aarhus

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Department of Endocrinology, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SA monitored by GH
Drug: Sandostatin® LAR
Intramuscular injections, dosage based on either GH or IGF-I levels.
Experimental: SA monitored by IGF-I
Drug: Sandostatin® LAR
Intramuscular injections, dosage based on either GH or IGF-I levels.
No Intervention: Control
Control, patients who have achieved sufficient disease control by surgery alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and after 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SA dosage
Time Frame: After 12 months of treatment
SA dosage at last follow-up
After 12 months of treatment
Change in glucose, FFA and insulin
Time Frame: Baseline and after 12 months
Glucose tolerance during an oral glucose load of 75 gram of glucose
Baseline and after 12 months
Change in discordant GH/IGF-I levels
Time Frame: Baseline and after 12 months
Discordant GH/IGF-I levels are recorded.
Baseline and after 12 months
New biomarkers of treatment evaluation
Time Frame: Baseline and after 12 months
New biomarkers of GH/IGF-I status (bioactive IGF-I)
Baseline and after 12 months
New biomarkers of treatment evaluation2
Time Frame: Baseline and after 12 months
New biomarkers of GH/IGF-I status (free GH)
Baseline and after 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Odense University Hospital
Aarhus University Hospital
Herlev Hospital
Aalborg University Hospital
Copenhagen University Hospital, Denmark

Investigators

  • Study Chair: Jens Otto L. Jørgensen, Professor, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (Estimate)

June 13, 2012

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOM-2012-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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