A feasibility study designed to provide justification for a full trial of hormone replacement therapy (HRT) for postmenopausal women with painful hand osteoarthritis met its predefined progression criteria and offered thoughts on refinement and protocol amendments. These findings were published by Williams et al in The Lancet Rheumatology. From May 2019 to December 2020, 434 inquiries/referrals into the HOPE-e feasibility study were received; participants in the study were women aged 40 to 65 years who had not had a menstrual period for 1 to 10 years with definite hand osteoarthritis and at least two painful hand joints. A total of 406 women were randomly assigned 1:1 to receive conjugated estrogens plus bazedoxifene or placebo; 250 were deemed ineligible for the study (20% due to medicine contraindications), 101 did not respond to follow-ups, and 55 chose not to proceed, leaving 28 randomly assigned patients, who completed all follow-up assessments. Protocol amendments included increasing community recruitment and remote participation, as well as the broadening of inclusion criteria. The study authors concluded, “This first-ever feasibility study of a randomized controlled trial of HRT for postmenopausal women with painful hand osteoarthritis met its progression criteria, although it was not powered to detect a clinical effect. This outcome indicates that a full trial of an HRT in this population is feasible and acceptable and identifies potential refinements with regard to the design of such a trial.”


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