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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acromegaly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SA monitored by GH

Group Type EXPERIMENTAL

Sandostatin® LAR

Intervention Type DRUG

Intramuscular injections, dosage based on either GH or IGF-I levels.

SA monitored by IGF-I

Group Type EXPERIMENTAL

Sandostatin® LAR

Intervention Type DRUG

Intramuscular injections, dosage based on either GH or IGF-I levels.

Control

Control, patients who have achieved sufficient disease control by surgery alone.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sandostatin® LAR

Intramuscular injections, dosage based on either GH or IGF-I levels.

Intervention Type DRUG

Eligibility Criteria

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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