Abstract
BackgroundHand osteoarthritis (OA) is a common condition, causing pain, stiffness and reduced quality of life. Incidence is higher amongst women, particularly around the age of the menopause. Whilst the relationship between sex hormones and OA has been studied in vitro, in epidemiological studies and in clinical trials of hormone replacement therapy (HRT), this study is the first to investigate the effect of estrogen-containing therapy on hand pain in post-menopausal women with symptomatic hand OA in a randomised study design.MethodsThis is a feasibility study of a double-blinded placebo-controlled intervention with 1:1 randomisation to either a combination of conjugated estrogens 0.45 mg and bazedoxifene acetate 20 mg (Duavive) or placebo. The target population is post-menopausal women with symptomatic hand OA, aiming to recruit 60–90 study participants. The primary objective is to assess the feasibility of a future fully powered randomised controlled trial (RCT). Participants will take the study medication for 24 weeks and be followed up for 28 weeks after randomisation. The primary outcomes used to determine feasibility are eligible participant identification rates and routes; recruitment, randomisation and retention rates of eligible participants; study medication compliance; and the likelihood of unintentional unblinding. Secondary outcomes include measures of hand pain, function, appearance and menopausal symptoms. An end of study questionnaire and focus groups will help to refine the final protocol for a full study.DiscussionIdentifying new treatments for symptomatic hand OA is a recognised research priority. The study will help us to understand whether there are sufficient interested and eligible individuals in this target population who would consider HRT for their hand symptoms. It will provide proof-of-concept RCT data on the effects of HRT on hand pain and other clinically relevant outcomes in this population. The study will gain valuable information on the feasibility of a full RCT and how best to run this. The findings will be published in a peer-reviewed journal and presented at a relevant conference.Trial registrationISRCTN12196200 registered on 15 January 2019.
Highlights
Hand osteoarthritis (OA) is a common condition, causing pain, stiffness and reduced quality of life
Characterised by an early, painful inflammatory phase and bony remodelling, the condition may involve the interphalangeal joints of the thumb and the fingers and the base of the thumb [3]
The incidence of hand OA is higher in women than men at all ages; the greatest relative risk compared with men is at the age of 50–55 years, which is around the age of menopause, a time of hormonal change and progressive estrogen deficiency [12,13,14,15]
Summary
Hand osteoarthritis (OA) is a common condition, causing pain, stiffness and reduced quality of life. Recommendations for the management of hand OA include general advice on joint protection, hand exercises, splinting, analgesia (such as topical antiinflammatory gel) and sometimes intra-articular steroid injections ( their routine use is somewhat controversial) [4,5,6]. Whilst these treatments are often helpful, their effectiveness is frequently modest and they are not suitable for the entire population with hand OA [7,8,9]. The incidence of hand OA is higher in women than men at all ages; the greatest relative risk compared with men is at the age of 50–55 years, which is around the age of menopause, a time of hormonal change and progressive estrogen deficiency [12,13,14,15]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
