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

University of Aarhus

Status and phase: Completed; Phase 4

Conditions: Acromegaly

Treatments: Drug: Sandostatin® LAR

Study type: Interventional

Funder types: Other

Identifiers

NCT01618513

SOM-2012-01

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 3 patient groups

SA monitored by GH

Experimental group

Treatment:

Drug: Sandostatin® LAR

SA monitored by IGF-I

Experimental group

Treatment:

Drug: Sandostatin® LAR

Control

No Intervention group

Description:

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