Recruiting NCT06367283

Metformin Treatment of Patients with Hand Osteoarthritis

Phase III Interventional Hand Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Metformin, Placebo.
Who it may be relevant to: Registry conditions: Hand Osteoarthritis. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Denmark
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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.

Drug 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.
Drug Placebo
Participants in the placebo group will receive a placebo tablet identical to the metformin tablet

Secondary outcome measures (8)

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

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Denmark · 1 center

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

NCT: NCT06367283 · 2023-509181-38-00