Sandostatin LAR Depot vs. Surgery for Treating Acromegaly

Summary

The purpose of this study is to compare the efficacy of Sandostatin LAR® (Registered Trademark) Depot to transsphenoidal surgery in previously untreated acromegalic patients with macroadenomas. The primary goal is to normalize insulin-like growth factor-1 (IGF-1) levels. Secondary goals are to compare Sandostatin LAR® (Registered Trademark) Depot treatment and transsphenoidal surgery to achieve the following goals: suppress growth hormone levels to less than or equal to 2.5 ng/mL, relieve the clinical signs and symptoms of acromegaly, reduce the size of the macroadenomas, produce few side effects, assess the prognostic value of baseline pituitary adenoma size, extension and baseline growth hormone level on post-treatment growth hormone and IGF-1 levels, and assess the resource utilization of each treatment type.

Timeline

Start

1999-08

Primary completion

—

Completion

2002-07

Publications

• Background Barkan AL. Acromegaly. Diagnosis and therapy. Endocrinol Metab Clin North Am. 1989 Jun;18(2):277-310.
• Background Bates AS, Van't Hoff W, Jones JM, Clayton RN. An audit of outcome of treatment in acromegaly. Q J Med. 1993 May;86(5):293-9.
• Background Melmed S, Jackson I, Kleinberg D, Klibanski A. Current treatment guidelines for acromegaly. J Clin Endocrinol Metab. 1998 Aug;83(8):2646-52. doi: 10.1210/jcem.83.8.4995.

Drugs

Indications