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© 2022 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. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NL70796.078.19.

Details

Title
Accelerated menopausal changes as human disease model ‘FOCUM’ for the development of osteoarthritis and other degenerative disorders: protocol for a prospective cohort study
Author
Molendijk, Eveline 1   VIAFID ORCID Logo  ; Schiphof, Dieuwke 1 ; Oei, Edwin H G 2 ; Robert-Jan de Vos 3   VIAFID ORCID Logo  ; P Koen Bos 3 ; Joyce B J van Meurs 4 ; Lubberts, Erik 5 ; Zillikens, M Carola 6 ; Bram C J van der Eerden 6 ; Kavousi, Maryam 7 ; Schouten, Boris W V 1 ; Mariëlla I B de Rooij-Duran 8 ; Sita M A Bierma-Zeinstra 9 

 Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands 
 Department of Radiology and Nuclear Medicine, Erasmus Medical Center, Rotterdam, The Netherlands 
 Department of Orthopaedics and Sports Medicine, Erasmus Medical Center, Rotterdam, The Netherlands 
 Department of Orthopaedics and Sports Medicine, Erasmus Medical Center, Rotterdam, The Netherlands; Department of Internal Medicine, Erasmus Medical Center, Rotterdam, The Netherlands 
 Department of Rheumatology, Erasmus Medical Center, Rotterdam, The Netherlands 
 Department of Internal Medicine, Erasmus Medical Center, Rotterdam, The Netherlands 
 Department of Epidemiology, Erasmus Medical Center, Rotterdam, The Netherlands 
 Service Apotheek Pendrecht, Rotterdam, The Netherlands 
 Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands; Department of Orthopaedics and Sports Medicine, Erasmus Medical Center, Rotterdam, The Netherlands 
First page
e064779
Section
General practice / Family practice
Publication year
2022
Publication date
2022
Publisher
BMJ Publishing Group LTD
e-ISSN
20446055
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2736462860
Copyright
© 2022 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. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.