1. Addition of weekly pegvisomant administrations improves quality of life; 2. Addition of weekly pegvisomant administrations improves insulin sensitivity.
ID
Bron
Aandoening
Acromegaly, pituitary disease, normal IGF1, somatostatin analogues, Pegvisomant
Ondersteuning
Dept. of Medicine
PO Box 2040
3000 CA Rotterdam NL
Tel: +31 10 703 2862
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Change in the Quality of Life over 16 weeks as assessed by AcroQoL and PASQ.
Achtergrond van het onderzoek
Randomized double blind multi-centre study of the effects on low-dose pegvisomant treatment in acromegalic subjects in whom the IGF-I levels has been normalized by long-acting somatostatin analogs.
Primary Study Objective:
To assess the efficacy and safety of the co-administration of low-dose pegvisomant (40 mg, administered via subcutaneous injection given once a week) and long-acting somatostatin analogs (administered once monthly) on the Quality of Life over 16 weeks in 60 acromegalic patients.
The primary endpoint will be the change in the AcroQol-physical score at the end of the treatment period.
Secondary Study Objectives:
To assess the effect of low-dose pegvisomant co-administration on: Quality of life and insuline sensitivity.
1. AcroQoL and PASQ;
2. Oral glucose loading;
3. Total body water / body weight;
4. Blood pressure;
5. HbA1c;
6. BNP levels;
7. Ring-size;
8. IGF-I levels;
9. Safety based on:
A. Adverse events, clinical examination, vital signs;
B. Glucose tolerance;
C. Standard hematology and biochemistry, including liver function tests.
Doel van het onderzoek
1. Addition of weekly pegvisomant administrations improves quality of life;
2. Addition of weekly pegvisomant administrations improves insulin sensitivity.
Onderzoeksopzet
Efficacy will be assessed as change between prestudy visit and visit at 16 weeks.
Onderzoeksproduct en/of interventie
Weekly sc administration of Pegvisomant (40 mg) or placebo during 16 weeks.
Publiek
Dept. of Medicine<br>
PO Box 2040
S.J.C.M.M. Neggers
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7032862
s.neggers@erasmusmc.nl
Wetenschappelijk
Dept. of Medicine<br>
PO Box 2040
S.J.C.M.M. Neggers
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7032862
s.neggers@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Provision of written informed consent prior to any study related procedures;
2. Male or female aged between 18 and 75 years inclusive;
3. The patient must have had documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF-1 levels;
4. The patient is treated with lanreotide Autogel or octreotide LAR for at least 6 months and has a serum IGF-1 level above the 60th percentile and below ULN, 28 days after the last injection.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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;
3. Has a history of hypersensitivity to lanreotide, octreotide or pegvisomant or drugs with a similar chemical structure;
4. Has already been treated with a somatostatin analogue associated with pegvisomant;
5. Has received a dopamine agonist within 6 weeks prior to study entry;
6. Has been treated with any unlicensed drug within the last 30 days before study entry;
7. Has abnormal hepatic function at study entry (defined as AST, ALT, gGT, alkaline phosphatase, or total bilirubin above 2 ULN);
8. Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test within 5 days before the start of the study and must be using contraception. Non-childbearing potential is defined as post-menopause for at least one year, surgical sterilization or hysterectomy at least three months before the start of the study;
9. Has a history of, or known current, problems with alcohol or drug abuse;
10. Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude;
11. Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study;
12. Renal insufficiency, clearance < 60 ml/min;
13. Participation in a clinical trial in the last 6 months.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2886 |
| NTR-old | NTR3032 |
| Ander register | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Samenvatting resultaten
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.