Accelerated menopausal changes as human disease model 'FOCUM' for the development of osteoarthritis and other degenerative disorders: protocol for a prospective cohort study.
INTERNAL MEDICINE
Magnetic resonance imaging
Musculoskeletal disorders
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
14 11 2022
14 11 2022
Historique:
entrez:
14
11
2022
pubmed:
15
11
2022
medline:
18
11
2022
Statut:
epublish
Résumé
The incidence of degenerative disorders, including osteoarthritis (OA), increases rapidly in women after menopause. However, the influence of the menopause is still insufficiently investigated due to the slowness of menopausal transition. In this study, a novel human model is used in which it is expected that menopausal-related changes will occur faster. This is the Females discontinuing Oral Contraceptives Use at Menopausal age model. The ultimate aim is to link these changes to OA and other degenerative disorders, including cardiovascular diseases, diabetes, osteoporosis and tendinopathies. This is a pilot observational prospective cohort study with 2 years of follow-up. Fifty women aged 50-60 who use oral contraceptive (OC) and have the intention to stop are included. Measurements are performed once before stopping OC, and four times thereafter at 6 weeks, 6 months, 1 year and 2 years. At every time point, a questionnaire is filled in and a sample of blood is drawn. At the first and final time points, a physical examination, hand radiographs and a MRI scan of one knee are performed. The primary OA outcome is progression of the MRI Osteoarthritis Knee Score. Secondary OA outcomes are the development of clinical knee and hand OA, development of knee OA according to the MRI definition, and progression of radiographic features for hand OA. Principal component analysis will be used to assess which changes occur after stopping OC. Univariate and multivariate generalised estimating equation models will be used to test for associations between these components and OA. The study has been approved by the Medical Ethics Committee of the Erasmus MC University Medical Center Rotterdam (MEC-2019-0592). All participants must give informed consent before data collection. Results will be disseminated in national and international journals. NL70796.078.19.
Identifiants
pubmed: 36375984
pii: bmjopen-2022-064779
doi: 10.1136/bmjopen-2022-064779
pmc: PMC9664313
doi:
Types de publication
Journal Article
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e064779Informations de copyright
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
Br J Sports Med. 2010 Dec;44(16):1153-9
pubmed: 19666626
Rheumatology (Oxford). 2009 Sep;48(9):1160-5
pubmed: 19608726
Pain Med. 2018 Jan 1;19(1):184-192
pubmed: 28387861
Osteoarthritis Cartilage. 2011 Aug;19(8):963-9
pubmed: 21620986
Rheumatology (Oxford). 2017 May 1;56(5):745-752
pubmed: 28077692
Arthritis Rheum. 1986 Aug;29(8):1039-49
pubmed: 3741515
Osteoarthritis Cartilage. 2008 May;16(5):533-41
pubmed: 18280756
J Clin Epidemiol. 2003 Dec;56(12):1163-9
pubmed: 14680666
Osteoarthritis Cartilage. 2011 Aug;19(8):990-1002
pubmed: 21645627
Osteoarthritis Cartilage. 2014 Oct;22(10):1533-6
pubmed: 25278062
Am J Med. 2015 Aug;128(8):888-895.e4
pubmed: 25818496
Ann Rheum Dis. 2009 Aug;68(8):1260-4
pubmed: 18728047
Ann Rheum Dis. 2011 Aug;70(8):1465-7
pubmed: 21558294
Health Qual Life Outcomes. 2004 Sep 02;2:45
pubmed: 15345062
Health Qual Life Outcomes. 2008 Feb 26;6:16
pubmed: 18302729
Osteoarthritis Cartilage. 2007;15 Suppl A:A1-56
pubmed: 17320422
Br J Sports Med. 2011 Apr;45(5):387-92
pubmed: 21047840
Arthritis Rheum. 1990 Nov;33(11):1601-10
pubmed: 2242058