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:
Participant gender:
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