{"type":"trials","record":{"id":41087,"source_id":"clinicaltrials-gov","external_id":"NCT02046668","title":"The Effect of Spironolactone on Pain in Older People With Osteoarthritis","brief_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.","overall_status":"Completed","phases":["PHASE4"],"study_type":"INTERVENTIONAL","sponsor":"University of Dundee","enrollment":86,"countries":["United Kingdom"],"start_date":"2013-11-01","completion_date":"2015-05-01","last_update_date":"2019-10-14","source_url":"https://clinicaltrials.gov/study/NCT02046668","editorial_summary":"A registered PHASE4 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:26.536053+00:00","last_seen_at":"2026-09-25T03:10:58.794+00:00","metadata":{"acronym":"SPIR-OA","organization":"University of Dundee","source_has_results":false},"controlled_terms":["Osteoarthritis, Knee","spironolactone"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: osteoarthritis.","quality_checked_at":"2026-09-25T03:11:01.385369+00:00","duplicate_cluster_key":"id:nct02046668","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2013-11-01 to 2015-05-01","comparator":null,"confidence":"structured-source","population":null,"provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T03:40:00.377838+00:00","intervention":[],"participants":86,"study_design":"INTERVENTIONAL","subject_scope":"Human clinical study registration","evidence_stage":"PHASE4","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":[],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"joint-cartilage-aging","is_published":true,"match_reasons":["Title contains controlled term: osteoarthritis.","Abstract contains controlled term: osteoarthritis.","Source terminology contains: osteoarthritis.","Title supplies longevity context: older people.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Joint and cartilage ageing","slug":"joint-cartilage-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/41087","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}