Clinical trial NCT00521300: Preoperative Octreotide Treatment of Acromegaly
Official title: Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acromegaly
Keywords: Acromegaly
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2007-08-27
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Surgical cure by transsphenoidal surgery
timeFrame: Primarily 3 months postoperatively, but up to 10 years postoperatively
Secondary outcomes:
measure: 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
timeFrame: Primarily 3 months postoperatively, but up to 10 years postoperatively
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Endocrinology Unit, Department of Medicine, Haukeland University Hospital
city: Oslo
country: Norway
facility: Endocrinology Unit, Department of Medicine, Aker University Hospital
city: Oslo
country: Norway
facility: Endocrinology Unit, Department of Medicine, Rikshospitalet-Radiumhospitalet Medical Center
city: Tromsø
country: Norway
facility: Endocrinology Unit, Department of Medicine, University Hospital of North Norway
city: Trondheim
country: Norway
facility: Department of Endocrinology, St. Olavs Hospital
Study officials:
affiliation: Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway
name: Sven M Carlsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.