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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Odense University Hospital | OTHER |
| Herlev Hospital | OTHER |
| Copenhagen University Hospital, Denmark |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SA monitored by GH | Experimental |
| |
| SA monitored by IGF-I | Experimental |
| |
| Control | No Intervention | Control, patients who have achieved sufficient disease control by surgery alone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sandostatin® LAR | Drug | Intramuscular injections, dosage based on either GH or IGF-I levels. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Otto L. Jørgensen, Professor | Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, Aarhus University Hospital | Aarhus C | 8000 | Denmark |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| OTHER |
| Aalborg University Hospital | OTHER |
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| 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 |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |