Change in Quality of Life After Addition of Weekly 40 mg Pegvisomant/Placebo in Controlled Acromegalic Patients

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Study Synopsis Study Title: Double blind, single centre, cross-over study on the effects of weekly subcutaneous administration of 40 mg pegvisomant or placebo on quality of life and insulin sensitivity in acromegalic patients with normal serum IGF-I concentrations during long-term treatment with long-acting somatostatin analogs

Study Objectives:

1. To determine whether the addition of weekly pegvisomant administrations improves quality of life

2. To determine whether the addition of weekly pegvisomant administrations improves insulin sensitivity

Study Population: Acromegalic patients, who have normalized their serum IGF-I levels down to the upper 25 centiles of normality during long-term treatment with monthly injections of a long-acting somatostatin analogue Number of Subjects: 20

Procedures:

• Patients on treatment with Sandostatin LAR (SL) 20 - 30 mg per months i.m. or patients on treatment with Lanreotide autosolution (LA) 90 - 120 mg deep s.c. will be enrolled.

• For 4 months, all subjects will also receive weekly s.c. injections of either placebo or a fixed dose of 40 mg pegvisomant

• After a 4 weeks wash-out period, patients will switch from either placebo to pegvisomant or from pegvisomant to placebo

• Before, and after 2 and 4 months of each treatment period, serum efficacy parameters and quality of life (AcroQol ™/ PASQ™) will be assessed.

• Before and after 4 months of each treatment period, pituitary tumor size and insulin sensitivity (HOMA/SIGMA model) will be assessed. Duration of study: 9 months

Hypothesis:

•We postulate that co-administration of the growth hormone receptor antagonist pegvisomant will improve QoL and insulin sensitivity

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center

Criteria

Inclusion Criteria:

• Active acromegaly.

• Serum total IGF-I levels must have been normalized during long-term treatment with long-acting somatostatin analogs

• Age between 18 and 80

Exclusion Criteria:

• Any contra-indication for the use of long-acting somatostatin analogs, as e.g. the use of anti-coagulants.

• Subjects with pituitary tumors that compress the optic chiasm

• Patients with insulin dependent diabetes

• Patients with cancer

• Patients with kidney- or liver function disturbances

• Fertile female patients that refuse to take contraceptives during the study