| ID | Type | Description | Link |
|---|---|---|---|
| S-71-98 | Other Identifier | REK | |
| SLKNR 98-5560 | Other Identifier | SLK |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The purpose of this study is to investigate whether 6 months preoperative treatment with the somatostatin analogue octreotide improves the surgical outcome in patients with acromegaly.
After a baseline evaluation, patients are randomized separately for each study center in blocks of four directly to transsphenoidal surgery or to 6-month preoperative treatment with octreotide.
To reduce the risk of gastrointestinal adverse effects in the pretreatment group, octreotide is initiated at a dose of 50 µg sc three times a day for the 1st week and 100 µg sc three times a day for the 2nd week. From the 3rd week on, the patients receive octreotide LAR (Novartis International AG, Basel, Switzerland) 20 mg im every 28th day for 6 months. Patients receive transsphenoidal surgery within 28 d of the last injection. If surgery are delayed, an extra octreotide LAR injection is given before surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| octreotide | Experimental | 6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly |
|
| standard surgery | Active Comparator | Standard transphenoidal surgery soon after the diagnosis of acromegaly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide | Drug | First week: Octreotide 50 micrograms subcutaneously three times daily. Second week: Octreotide 100 micrograms subcutaneously three times daily. From the third week on: Octreotide LAR 20 mg intramuscularly every 28th day for 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical cure by transsphenoidal surgery | Primarily 3 months postoperatively, but up to 10 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of treatment on surgical complications and duration of hospital stay, pituitary function, quality of life, and the need for postsurgical medical treatment of acromegaly | Primarily 3 months postoperatively, but up to 10 years postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sven M Carlsen, MD, PhD | Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrinology Unit, Department of Medicine, Haukeland University Hospital | Bergen | Norway | ||||
| Endocrinology Unit, Department of Medicine, Aker University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18492760 | Result | Carlsen SM, Lund-Johansen M, Schreiner T, Aanderud S, Johannesen O, Svartberg J, Cooper JG, Hald JK, Fougner SL, Bollerslev J; Preoperative Octreotide Treatment of Acromegaly study group. Preoperative octreotide treatment in newly diagnosed acromegalic patients with macroadenomas increases cure short-term postoperative rates: a prospective, randomized trial. J Clin Endocrinol Metab. 2008 Aug;93(8):2984-90. doi: 10.1210/jc.2008-0315. Epub 2008 May 20. | |
| 21521254 |
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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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| ID | Term |
|---|---|
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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|
| Direct surgery for acromegaly | Procedure | Direct transsphenoidal surgery |
|
| Oslo |
| Norway |
| Endocrinology Unit, Department of Medicine, Rikshospitalet-Radiumhospitalet Medical Center | Oslo | Norway |
| Endocrinology Unit, Department of Medicine, University Hospital of North Norway | Tromsø | Norway |
| Department of Endocrinology, St. Olavs Hospital | Trondheim | 7006 | Norway |
| Result |
| Carlsen SM, Svartberg J, Schreiner T, Aanderud S, Johannesen O, Skeie S, Lund-Johansen M, Fougner SL, Bollerslev J; POTA study group. Six-month preoperative octreotide treatment in unselected, de novo patients with acromegaly: effect on biochemistry, tumour volume, and postoperative cure. Clin Endocrinol (Oxf). 2011 Jun;74(6):736-43. doi: 10.1111/j.1365-2265.2011.03982.x. |
| 24866574 | Result | Fougner SL, Bollerslev J, Svartberg J, Oksnes M, Cooper J, Carlsen SM. Preoperative octreotide treatment of acromegaly: long-term results of a randomised controlled trial. Eur J Endocrinol. 2014 Aug;171(2):229-35. doi: 10.1530/EJE-14-0249. Epub 2014 May 27. |
| 24092547 | Derived | Olarescu NC, Ueland T, Godang K, Lindberg-Larsen R, Jorgensen JO, Bollerslev J. Inflammatory adipokines contribute to insulin resistance in active acromegaly and respond differently to different treatment modalities. Eur J Endocrinol. 2013 Nov 22;170(1):39-48. doi: 10.1530/EJE-13-0523. Print 2014 Jan. |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |