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

Study Overview
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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.

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

Conditions
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Acromegaly

Intervention / Treatment
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* Drug: Sandostatin® LAR


Participation Criteria
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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 Exclusion Criteria: Pregnancy or nursing Any disease that may compromise the ability to comply with the protocol, as assessed by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acromegaly, Somatostatin analogs, Treatment