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Preoperative Octreotide Treatment of Acromegaly (POTA)

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Octreotide
Direct surgery for acromegaly
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Endocrinology Unit, Department of Medicine, Haukeland University Hospital
  • Endocrinology Unit, Department of Medicine, Aker University Hospital
  • Endocrinology Unit, Department of Medicine, Rikshospitalet-Radiumhospitalet Medical Center
  • Endocrinology Unit, Department of Medicine, University Hospital of North Norway
  • Department of Endocrinology, St. Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

octreotide

standard surgery

Arm Description

6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly

Standard transphenoidal surgery soon after the diagnosis of acromegaly

Outcomes

Primary Outcome Measures

Surgical cure by transsphenoidal surgery

Secondary Outcome Measures

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

Full Information

First Posted
August 24, 2007
Last Updated
May 30, 2014
Sponsor
St. Olavs Hospital
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00521300
Brief Title
Preoperative Octreotide Treatment of Acromegaly
Acronym
POTA
Official Title
Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
octreotide
Arm Type
Experimental
Arm Description
6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly
Arm Title
standard surgery
Arm Type
Active Comparator
Arm Description
Standard transphenoidal surgery soon after the diagnosis of acromegaly
Intervention Type
Drug
Intervention Name(s)
Octreotide
Other Intervention Name(s)
Sandostatin, Sandostatin LAR
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Direct surgery for acromegaly
Intervention Description
Direct transsphenoidal surgery
Primary Outcome Measure Information:
Title
Surgical cure by transsphenoidal surgery
Time Frame
Primarily 3 months postoperatively, but up to 10 years postoperatively
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven M Carlsen, MD, PhD
Organizational Affiliation
Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endocrinology Unit, Department of Medicine, Haukeland University Hospital
City
Bergen
Country
Norway
Facility Name
Endocrinology Unit, Department of Medicine, Aker University Hospital
City
Oslo
Country
Norway
Facility Name
Endocrinology Unit, Department of Medicine, Rikshospitalet-Radiumhospitalet Medical Center
City
Oslo
Country
Norway
Facility Name
Endocrinology Unit, Department of Medicine, University Hospital of North Norway
City
Tromsø
Country
Norway
Facility Name
Department of Endocrinology, St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
18492760
Citation
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.
Results Reference
result
PubMed Identifier
21521254
Citation
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.
Results Reference
result
PubMed Identifier
24866574
Citation
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.
Results Reference
result
PubMed Identifier
24092547
Citation
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.
Results Reference
derived

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Preoperative Octreotide Treatment of Acromegaly

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