Pegvisomant-toevoeging bij patiënten met acromegalie: Effect op symptomen, kwaliteit van leven en insuline-gevoeligheid.
- Conditions
- Acromegaly, pituitary disease, normal IGF1, somatostatin analogues, Pegvisomant
- Registration Number
- NL-OMON24812
- Lead Sponsor
- Erasmus University MCDept. of MedicinePO Box 20403000 CA Rotterdam NLTel: +31 10 703 2862
- Brief Summary
eggers SJ, van Aken MO, de Herder WW, Feelders RA, Janssen JA, Badia X, Webb SM, van der Lely AJ (2008) Quality of life in acromegalic patients during long-term somatostatin analog treatment with and without pegvisomant. The Journal of clinical endocrinology and metabolism 93 (10):3853-3859.<br> Biermasz NR, Pereira AM, Smit JW, Romijn JA, Roelfsema F (2005) Morbidity after long-term remission for acromegaly: persisting joint-related complaints cause reduced quality of life. The Journal of clinical endocrinology and metabolism 90 (5):2731-2739.<br> Bonapart IE, van Domburg R, ten Have SM, de Herder WW, Erdman RA, Janssen JA, van der Lely AJ (2005) The 'bio-assay' quality of life might be a better marker of disease activity in acromegalic patients than serum total IGF-I concentrations. European journal of endocrinology / European Federation of Endocrine Societies 152 (2):217-224.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
1. Provision of written informed consent prior to any study related procedures;
2. Male or female aged between 18 and 75 years inclusive;
1. Has undergone pituitary surgery or radiotherapy within 6 months prior to study entry;
2. It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the Quality of Life over 16 weeks as assessed by AcroQoL and PASQ.
- Secondary Outcome Measures
Name Time Method Insulin sensitivity after oral glucose loading.<br>and change in:<br /><br>1. Total body water /body weight;<br /><br>2. Blood pressure;<br /><br>3. HbA1c;<br /><br>4. BNP levels;<br /><br>5. Ring-size;<br /><br>6. IGF-I levels;<br /><br>7. GH levels;<br /><br>8. PEG-levels.