Preoperative Octreotide Treatment of Acromegaly

Phase 4

Completed

• Conditions: Acromegaly
• Interventions: Drug: Octreotide; Procedure: Direct surgery for acromegaly

• Registration Number: NCT00521300
• Lead Sponsor: St. Olavs Hospital

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.

Study Timeline

• Study Start: 1999-09
• Primary Completion: 2005-06
• Study First Submitted: 2007-08-24
• Study First Submitted QC: 2007-08-24
• Study First Posted: 2007-08-27
• Study Completion: 2010-05
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-30
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• GH nadir during a standard 75 g OGTT >= 5.0 mmol/L.
• Pituitary tumor by MRI-scan.

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Exclusion Criteria

• Immediate surgery indicated by usual clinical criteria.
• Pregnant.
• Known adverse effects of octreotide.
• Unfit for participation by any other reason.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
octreotide	Octreotide	6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly
standard surgery	Direct surgery for acromegaly	Standard transphenoidal surgery soon after the diagnosis of acromegaly

Primary Outcome Measures

Name	Time	Method
Surgical cure by transsphenoidal surgery	Primarily 3 months postoperatively, but up to 10 years postoperatively

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Endocrinology Unit, Department of Medicine, Haukeland University Hospital; 🇳🇴 Bergen, 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, Norway

Endocrinology Unit, Department of Medicine, Aker University Hospital; 🇳🇴 Oslo, Norway