Metformin Treatment of Patients with Hand Osteoarthritis

Официальное название

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

Обзор

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

Вмешательства

• Препарат Metformin
  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/day is reached, distributed as 1000 mg every morning and evening, together with a meal. If the subject cannot tolerate the maximum dose (2 g/day), the maximal tolerated dose will be given. The treatment period including titration is 16 weeks.
• Препарат Placebo
  Participants in the placebo group will receive a placebo tablet identical to the metformin tablet

Первичные конечные точки

• Finger pain [Срок оценки: Week 16]

Вторичные конечные точки (8)

• Function [Срок оценки: Week 16]
• Thumb base pain [Срок оценки: Week 16]
• Hand pain [Срок оценки: Week 16]
• Physician tender joint count [Срок оценки: Week 16]
• Patient global assessment [Срок оценки: Week 16]
• Quality of life assessed by the European Quality of life - 5 dimensions (EQ-5D) scale [Срок оценки: Week 16]
• Hand strength [Срок оценки: Week 16]
• Number of treatment responders [Срок оценки: Week 16]

Критерии участия

Критерии включения

• 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

Критерии исключения

Comorbidities

• History of, or current signs of medical disease that may affect joints, e.g. rheumatoid arthritis, gout, psoriatic arthritis
• Psoriasis
• Known malignancy (except successfully treated squamous or basal cell skin carcinoma)
• Drug or alcohol abuse in the last year
• Existing nerve entrapment syndromes (e.g. carpal tunnel syndrome)
• Known diabetes
• Generalised pain syndromes such as fibromyalgia
• Known peripheral neuropathies
• Known allergies towards the interventions
• Gastric bypass or other malabsorption syndrome
• 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
• 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 hand surgery in the target hand within 12 months prior to enrolment
• History of arthroplasty, arthrodesis or surgical treatment of thumb base osteoarthritis in the target hand

Management strategies

• 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
• 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
• 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

• 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
• 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)
• Breast-feeding

Blood analysis

• Positive anti-cyclic citrullinated peptide (>10 kU/L)
• eGFR <60 ml/min/1.73 m2
• Vitamin B12 deficiency < 200 pmol/L
• Hba1c ≥ 48 mmol/mol

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• The Parker Institute, Bispebjerg and Frederiksberg hospital — Copenhagen

Публикации

• Madsen KS, Henriksen M, Dossing A, Poulsen AS, Oscar R, Kragstrup T, Ellegaard K, Knop FK, Boesen M, Hunter DJ, Christensen R, Bliddal H. Metformin treatment for patients with hand osteoarthritis: protocol for the multicentre, randomised, placebo-controlled METRO trial. BMJ Open. 2025 Mar 26;15(3):e093831. doi: 10.1136/bmjopen-2024-093831. PMID 40139705

Идентификаторы

NCT: NCT06367283 · 2023-509181-38-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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