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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01618513

Enrollment

Registered

2012-06-13

Start date

2012-06-30

Completion date

2017-01-31

Last updated

2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Keywords

Acromegaly, Somatostatin analogs, Treatment

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.

Interventions

DRUGSandostatin® LAR

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026