Preoperative Octreotide Treatment of Acromegaly
POTA
3 other identifiers
interventional
62
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 1999
Longer than P75 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 24, 2007
CompletedFirst Posted
Study publicly available on registry
August 27, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJune 2, 2014
May 1, 2014
5.8 years
August 24, 2007
May 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Surgical cure by transsphenoidal surgery
Primarily 3 months postoperatively, but up to 10 years postoperatively
Secondary Outcomes (1)
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
Study Arms (2)
octreotide
EXPERIMENTAL6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly
standard surgery
ACTIVE COMPARATORStandard transphenoidal surgery soon after the diagnosis of acromegaly
Interventions
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
Eligibility Criteria
You may qualify if:
- GH nadir during a standard 75 g OGTT \>= 5.0 mmol/L.
- Pituitary tumor by MRI-scan.
You may not qualify if:
- Immediate surgery indicated by usual clinical criteria.
- Pregnant.
- Known adverse effects of octreotide.
- Unfit for participation by any other reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Olavs Hospitallead
- Novartiscollaborator
Study Sites (5)
Endocrinology Unit, Department of Medicine, Haukeland University Hospital
Bergen, Norway
Endocrinology Unit, Department of Medicine, Aker University Hospital
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
Related Publications (4)
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.
PMID: 18492760RESULTCarlsen 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.
PMID: 21521254RESULTFougner 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.
PMID: 24866574RESULTOlarescu 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.
PMID: 24092547DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sven M Carlsen, MD, PhD
Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2007
First Posted
August 27, 2007
Study Start
September 1, 1999
Primary Completion
June 1, 2005
Study Completion
May 1, 2010
Last Updated
June 2, 2014
Record last verified: 2014-05