Preoperative Octreotide Treatment of Acromegaly (POTA)
May 30, 2014 updated by: St. Olavs Hospital
Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bergen, Norway
- Endocrinology Unit, Department of Medicine, Haukeland University Hospital
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Oslo, Norway
- Endocrinology Unit, Department of Medicine, Aker University Hospital
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Oslo, Norway
- Endocrinology Unit, Department of Medicine, Rikshospitalet-Radiumhospitalet Medical Center
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Tromsø, Norway
- Endocrinology Unit, Department of Medicine, University Hospital of North Norway
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Trondheim, Norway, 7006
- Department of Endocrinology, St. Olavs Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- GH nadir during a standard 75 g OGTT >= 5.0 mmol/L.
- Pituitary tumor by MRI-scan.
Exclusion Criteria:
- Immediate surgery indicated by usual clinical criteria.
- Pregnant.
- Known adverse effects of octreotide.
- Unfit for participation by any other reason.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: octreotide
6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly
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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
Other Names:
|
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Active Comparator: standard surgery
Standard transphenoidal surgery soon after the diagnosis of acromegaly
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Direct transsphenoidal surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Surgical cure by transsphenoidal surgery
Time Frame: Primarily 3 months postoperatively, but up to 10 years postoperatively
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Primarily 3 months postoperatively, but up to 10 years postoperatively
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Secondary Outcome Measures
Outcome Measure |
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
Time Frame: Primarily 3 months postoperatively, but up to 10 years postoperatively
|
Primarily 3 months postoperatively, but up to 10 years postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sven M Carlsen, MD, PhD, Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1999
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
August 24, 2007
First Submitted That Met QC Criteria
August 24, 2007
First Posted (Estimate)
August 27, 2007
Study Record Updates
Last Update Posted (Estimate)
June 2, 2014
Last Update Submitted That Met QC Criteria
May 30, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Endocrine System Diseases
- Musculoskeletal Diseases
- Hypothalamic Diseases
- Bone Diseases
- Bone Diseases, Endocrine
- Hyperpituitarism
- Pituitary Diseases
- Acromegaly
- Antineoplastic Agents
- Gastrointestinal Agents
- Antineoplastic Agents, Hormonal
- Octreotide
Other Study ID Numbers
- S-71-98 (REK)
- S-71-98 (Other Identifier: REK)
- SLKNR 98-5560 (Other Identifier: SLK)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.