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

Phase 4

Completed

• Conditions: Acromegaly
• Interventions: Drug: Sandostatin® LAR

• Registration Number: NCT01618513
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-13
• Status Verified: 2014-12
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

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Exclusion Criteria

• Pregnancy or nursing
• Any disease that may compromise the ability to comply with the protocol, as assessed by the investigator

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SA monitored by GH	Sandostatin® LAR	-
SA monitored by IGF-I	Sandostatin® LAR	-

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life	Baseline and after 12 months	AcroQol (Acromegaly Quality of Life Questionnaire) and PASQ (Patient-Assessed Acromegaly Symptom Questionnaire)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Endocrinology, Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark