Metformin Treatment of Patients with Hand Osteoarthritis

Trial details

Who runs it

Marius Henriksen

Trial code

NCT06367283

Record updated

27 February 2025

Original description

To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms.Read full original descriptionShow less

Metformin Treatment of Patients with Hand Osteoarthritis: a Randomised, Placebo-controlled Trial

To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms.

Inclusion: Age ≥18 years; Hand OA according to the ACR criteria; 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; Metformin naive.

Exclusion: Drug or alcohol abuse in the last year; 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; History of hand surgery in the target hand within 12 months prior to enrolment; Use of systemic corticosteroids equivalent of ≥ 7.5 mg prednisolone daily within 3 months; Treatment with denosumab (Prolia/Xgeva); Participation in experimental device or experimental drug study 3 months prior to enrolment; Intra-articular treatments of any kind of any joint of the target hand 3 months before inclusion; Scheduled surgery on upper extremity of the target hand during study participation; Scheduled surgery requiring pause of metformin, e.g. surgery in general anaesthesia, during study participation; Reproductive system; Insufficient anti-conception therapy for female fertile participants within the study period and 3 months after end of study treatment; 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; Female participants are considered infertile if they are postmenopausal or if they have undergone surgical sterilisation (bilateral salpingectomy, hysterectomy or bilateral oophorectomy); Postmenopausal state is defined as no menses for 12 months without alternative medical cause before inclusion in the study; Insufficient anti-conception therapy for male participants within the study period and 6 months after end of study treatment; Sufficient anti-conception therapy consists of condom or sexual abstinence; Male participants are considered sterile if they have undergone surgical sterilisation (vasectomy); History of, or current signs of medical disease that may affect joints, e.g. rheumatoid arthritis, gout, psoriatic arthritis; Known malignancy (except successfully treated squamous or basal cell skin carcinoma); Existing nerve entrapment syndromes (e.g. carpal tunnel syndrome); Known diabetes; Generalised pain syndromes such as fibromyalgia; Known allergies towards the interventions; Gastric bypass or other malabsorption syndrome; 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; Surgical history; History of arthroplasty, arthrodesis or surgical treatment of thumb base osteoarthritis in the target hand; Management strategies; eGFR <60 ml/min/1.73 m2; Hba1c ≥ 48 mmol/mol; Comorbidities; Psoriasis; Known peripheral neuropathies; Current use of synthetic or non-synthetic opioids; Planning to start other treatment for hand OA in the study participation period; Planned CT scan with iodine contrast; Pregnancy; 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; Breast-feeding; Blood analysis; Positive anti-cyclic citrullinated peptide (>10 kU/L); Vitamin B12 deficiency < 200 pmol/L.

ClinicalTrials.gov NCT06367283