[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544315":3},{"organization":4,"outcomesModule":7,"designInfo":80,"detailedDescription":83,"studyPopulation":83,"armGroups":92,"interventions":103,"overallOfficials":83,"centralContacts":111,"locations":117,"responsibleParty":135,"collaborators":83,"id":139,"slug":83,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":140,"sex":146,"minAge":147,"maxAge":83,"enrollmentInfo":148,"targetDuration":83,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":83,"overallStatus":120,"whyStopped":83,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Frederiksberg University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Finger pain","Change from baseline in Visual Analogue Scale (VAS) finger joint pain of the target hand after 16 weeks of treatment","Week 16",[14,17,20,23,26,29,32,35],{"measure":15,"description":16,"timeFrame":12},"Function","Change from baseline after 16 weeks of treatment in physical function assessed by Australian\u002FCanadian Osteoarthritis Hand Index (AUSCAN) physical function subscale",{"measure":18,"description":19,"timeFrame":12},"Thumb base pain","Change from baseline after 16 weeks of treatment in Visual Analogue Scale thumb base pain of the target hand",{"measure":21,"description":22,"timeFrame":12},"Hand pain","Change from baseline after 16 weeks of treatment in pain of both hands assessed by Australian\u002FCanadian Osteoarthritis Hand Index hand pain subscale",{"measure":24,"description":25,"timeFrame":12},"Physician tender joint count","Change from baseline after 16 weeks of treatment in joint activity of the target hand assessed by physician tender joint count",{"measure":27,"description":28,"timeFrame":12},"Patient global assessment","Change from baseline after 16 weeks of treatment in Visual Analogue Scale patient global assessment",{"measure":30,"description":31,"timeFrame":12},"Quality of life assessed by the European Quality of life - 5 dimensions (EQ-5D) scale","Change from baseline after 16 weeks of treatment in quality of life assessed by the European Quality of life - 5 dimensions scale",{"measure":33,"description":34,"timeFrame":12},"Hand strength","Change from baseline after 16 weeks of treatment in hand strength of the target hand assessed by a grip dynamometer",{"measure":36,"description":37,"timeFrame":12},"Number of treatment responders","Responders will be identified according to OMERACT-OARSI criteria, defined as (1) improvement in finger pain (primary outcome) or function (secondary outcome) ≥50% and an absolute change ≥20 mm; or (2) improvement of ≥20% with an absolute change ≥10 mm in at least two of the following three: finger pain (primary outcome), function (secondary outcome), and patient global assessment (secondary outcome).",[39,42,45,48,51,54,57,60,63,66,69,72,74,77],{"measure":40,"description":41,"timeFrame":12},"Stiffness of both hands","Change in stiffness of both hands measured on the Australian\u002FCanadian Osteoarthritis Hand Index (AUSCAN) stiffness subscale",{"measure":43,"description":44,"timeFrame":12},"Composite of pain, function and stiffness","Change in pain, function and stiffness of both hands measured composite on the Australian\u002FCanadian Osteoarthritis Hand Index (AUSCAN) Hand Index Score",{"measure":46,"description":47,"timeFrame":12},"Physical function","Change in physical function of both hands assessed by the Health Assessment Questionnaire Disability Index (HAQ-DI)",{"measure":49,"description":50,"timeFrame":12},"Physician global assessment","Change in physician global assessment of disease activity of hand OA in the target hand measured on a Visual Analogue Scale (VAS) scale",{"measure":52,"description":53,"timeFrame":12},"Swollen joint count","Change in physician swollen joint count of the target hand",{"measure":55,"description":56,"timeFrame":12},"Fatigue","Change in fatigue measured on a Visual Analogue Scale (VAS) scale",{"measure":58,"description":59,"timeFrame":12},"Sleep quality","Change in sleep quality measured on the Pittsburgh Sleep Quality Index (PSQI)",{"measure":61,"description":62,"timeFrame":12},"Absence or presence of inflammation of target hand","Change in absence or presence of inflammation of the target hand as measured by ultrasound (US)",{"measure":64,"description":65,"timeFrame":12},"Change in use of analgesics","Change in use of analgesics measured as the use of paracetamol and NSAIDS",{"measure":67,"description":68,"timeFrame":12},"Inflammatory biomarker","Change in hsCRP mg\u002FL",{"measure":70,"description":71,"timeFrame":12},"Metabolic outcomes","Change in HbA1c mmol\u002Fmol",{"measure":70,"description":73,"timeFrame":12},"Change in lipids mmol\u002FL",{"measure":75,"description":76,"timeFrame":12},"Vitamin K","Change in vitamin K and dephospho-uncarboxylated matrix Gla-protein ((dp)ucMGP) pmol\u002FL",{"measure":78,"description":79,"timeFrame":12},"Proteomics","Change in mass-spectrometry based proteomics",{"allocation":81,"interventionModel":82,"interventionModelDescription":83,"primaryPurpose":84,"observationalModel":83,"timePerspective":83,"maskingInfo":85},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":86,"maskingDescription":83,"whoMasked":87},"QUADRUPLE",[88,89,90,91],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[93,98],{"label":94,"type":95,"description":83,"interventionNames":96},"Metformin","EXPERIMENTAL",[97],"Drug: Metformin",{"label":99,"type":100,"description":83,"interventionNames":101},"Placebo","PLACEBO_COMPARATOR",[102],"Drug: Placebo",[104,108],{"type":105,"name":94,"description":106,"armGroupLabels":107,"otherNames":83},"DRUG","Metformin will be initiated at 500 mg once daily with breakfast meal. The dose will be increased with 500 mg every week until 2 g\u002Fday is reached, distributed as 1000 mg every morning and evening, together with a meal. If the subject cannot tolerate the maximum dose (2 g\u002Fday), the maximal tolerated dose will be given. The treatment period including titration is 16 weeks.",[94],{"type":105,"name":99,"description":109,"armGroupLabels":110,"otherNames":83},"Participants in the placebo group will receive a placebo tablet identical to the metformin tablet",[99],[112],{"name":113,"role":114,"phone":115,"phoneExt":83,"email":116},"Kasper Staberg Madsen","CONTACT","+4538164162","kasper.staberg.madsen@regionh.dk",[118],{"facility":119,"status":120,"city":121,"state":122,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":131,"contacts":132},"The Parker Institute, Bispebjerg and Frederiksberg hospital","RECRUITING","Copenhagen","Frederiksberg","2000","Denmark","DK",{"type":127,"coordinates":128},"Point",[129,130],12.56553,55.67594,{"lat":130,"lon":129},[133],{"name":134,"role":114,"phone":115,"phoneExt":83,"email":116},"Kasper Staberg Madsen, MD",{"type":136,"investigatorFullName":137,"investigatorTitle":138,"investigatorAffiliation":5,"oldNameTitle":83,"oldOrganization":83},"SPONSOR_INVESTIGATOR","Marius Henriksen","Professor","100544315",false,"NCT06367283","Metformin Treatment of Patients with Hand Osteoarthritis","Metformin Treatment of Patients with Hand Osteoarthritis: a Randomised, Placebo-controlled Trial","METRO","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Hand OA according to the ACR criteria\n3. Average finger (2 to 5) pain ≥4 on a 0-10 numeric rating scale (NRS where 10 is worst pain) over the past 30 days\n4. Metformin naive\n\nExclusion Criteria:\n\nComorbidities\n\n1. History of, or current signs of medical disease that may affect joints, e.g. rheumatoid arthritis, gout, psoriatic arthritis\n2. Psoriasis\n3. Known malignancy (except successfully treated squamous or basal cell skin carcinoma)\n4. Drug or alcohol abuse in the last year\n5. Existing nerve entrapment syndromes (e.g. carpal tunnel syndrome)\n6. Known diabetes\n7. Generalised pain syndromes such as fibromyalgia\n8. Known peripheral neuropathies\n9. Known allergies towards the interventions\n10. Gastric bypass or other malabsorption syndrome\n11. In case of pharmacological weight loss medication (e.g. glucagon like peptide-1 (GLP-1) analogues) or pharmacological osteoporosis medication, dosage must have been stable for 3 months without any plan of up-titration during the study period\n12. Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or obstructs participation e.g. psychiatric disorders.\n\n    Surgical history\n13. History of hand surgery in the target hand within 12 months prior to enrolment\n14. History of arthroplasty, arthrodesis or surgical treatment of thumb base osteoarthritis in the target hand\n\n    Management strategies\n15. Use of systemic corticosteroids equivalent of ≥ 7.5 mg prednisolone daily within 3 months\n16. Treatment with denosumab (Prolia\u002FXgeva)\n17. Participation in experimental device or experimental drug study 3 months prior to enrolment\n18. Intra-articular treatments of any kind of any joint of the target hand 3 months before inclusion\n19. Current use of synthetic or non-synthetic opioids\n20. Planning to start other treatment for hand OA in the study participation period\n21. Planned CT scan with iodine contrast\n22. Scheduled surgery on upper extremity of the target hand during study participation\n23. Scheduled surgery requiring pause of metformin, e.g. surgery in general anaesthesia, during study participation\n\n    Reproductive system\n24. Pregnancy\n25. Planned pregnancy within the study period, 3 months after end of study treatment for female fertile participant and 6 months after end of study treatment for male participant\n26. Insufficient anti-conception therapy for female fertile participants within the study period and 3 months after end of study treatment\n\n    * Sufficient anti-conception therapy consists of intra-uterine device (coil), hormonal anti-conception (birth control pills, implant, intra-uterine system, dermal patch, vaginal ring, or injections) or sexual abstinence\n    * Female participants are considered infertile if they are postmenopausal or if they have undergone surgical sterilisation (bilateral salpingectomy, hysterectomy or bilateral oophorectomy)\n    * Postmenopausal state is defined as no menses for 12 months without alternative medical cause before inclusion in the study\n27. Insufficient anti-conception therapy for male participants within the study period and 6 months after end of study treatment\n\n    * Sufficient anti-conception therapy consists of condom or sexual abstinence\n    * Male participants are considered sterile if they have undergone surgical sterilisation (vasectomy)\n28. Breast-feeding\n\n    Blood analysis\n29. Positive anti-cyclic citrullinated peptide (\\>10 kU\u002FL)\n30. eGFR \\\u003C60 ml\u002Fmin\u002F1.73 m2\n31. Vitamin B12 deficiency \\\u003C 200 pmol\u002FL\n32. Hba1c ≥ 48 mmol\u002Fmol","ALL","18 Years",{"count":149,"type":150},150,"ESTIMATED","INTERVENTIONAL",[153],"PHASE3","To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms.",[156],"Hand Osteoarthritis","2025-02-25",{"date":159,"type":160},"2025-02-27","ACTUAL",{"date":162,"type":160},"2024-06-03",{"date":164,"type":150},"2026-04",{"name":137,"class":6},1]