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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Roberta
Littleford
r.littleford@dundee.ac.uk
Prof
Marion
McMurdo
m.e.t.mcmurdo@dundee.ac.uk
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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 know to be pro-inflammatory and spironolactone suppresses cytokine production in chronic arthritis. This applications builds on previous work by the applicatns showing that spironolactone significantly improved quality of life (particularly pain) in frail older people. We will recruit 86 people (aged 70 years and over) with well-defined OA 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 subscalesand 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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;Imaging;
You can take part if:
You may not be able to take part if:
1. Unable to give informed consent 2. Clinical diagnosis of symptomatic heart failure 3. History of inflammatory arthritis 4. Already taking spironolactone 5. Known allergies to spironolactone or lactose 6. Taking oral NSAIDS 7. Taking ACE inhibitors or ARBs (angiotenson II receptor antagonists) 8. Significant chronic kidney diease (rGFR<40ml/min) 9. Nursing home resident 10. Particpant who is terminally ill, defined as less than 3 months expected survival
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University of Dundee and funded by VERSUS ARTHRITIS .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 15324
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
