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Completed

NCT Number: NCT00521300

Preoperative Octreotide Treatment of Acromegaly

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.

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Endocrinology Unit, Department of Medicine, Haukeland University Hospital, Bergen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Octreotide

Drug

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: Sandostatin, Sandostatin LAR

Direct surgery for acromegaly

Procedure

Direct transsphenoidal surgery

Primary outcomes

  1. Surgical cure by transsphenoidal surgery

    Time frame: 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

    Time frame: Primarily 3 months postoperatively, but up to 10 years postoperatively

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Novartis

Registry information

Official study title

Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas

Acronym: POTA

Important dates

Study start
1999
Primary completion
2005
Study completion
2010
First posted
Aug 27, 2007
Registry last updated
Jun 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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