The Effect of Spironolactone on Pain in Older People With Osteoarthritis
Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
Summary
This pilot study will obtain preliminary evidence on which to base sample size calculations
for a future trial of whether spironolactone (an aldosterone blocker) reduces knee pain in
older people with symptomatic OA knee when given in addition to usual analgesia. Aldosterone
is known to be pro-inflammatory, and spironolactone suppresses cytokine production in chronic
arthritis. This application builds on previous work by the applicants showing that
spironolactone significantly improved quality of life (particularly pain) in frail older
people. The investigators will recruit 86 people (aged 70 years or over) with well-defined OA
knee to 25mg spironolactone daily or to matching placebo for 12 weeks. The primary outcome is
the between group difference in change in WOMAC pain sub-score at 12 weeks. Secondary
outcomes are the WOMAC stiffness and physical function subscales and health related quality
of life (EQ-5D). Morning cortisol levels will be measured to assess the effect of
mineralocorticoid receptor blockade on glucocorticoid levels, which may mediate the
anti-inflammatory effect of spironolactone; and urinary CTX-II, and serum matrix
metalloproteinase-3 (MMP-3) will be measured as biomarkers as both are sensitive to the
effects of pharmacological interventions for osteoarthritis.