Metformin Treatment of Patients with Hand Osteoarthritis
NCT ID: NCT06367283
Last Updated: 2025-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2024-06-03
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Metformin
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.
Placebo
Placebo
Participants in the placebo group will receive a placebo tablet identical to the metformin tablet
Interventions
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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.
Placebo
Participants in the placebo group will receive a placebo tablet identical to the metformin tablet
Eligibility Criteria
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Inclusion Criteria
2. Hand OA according to the ACR criteria
3. 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
4. Metformin naive
Exclusion Criteria
1. History of, or current signs of medical disease that may affect joints, e.g. rheumatoid arthritis, gout, psoriatic arthritis
2. Psoriasis
3. Known malignancy (except successfully treated squamous or basal cell skin carcinoma)
4. Drug or alcohol abuse in the last year
5. Existing nerve entrapment syndromes (e.g. carpal tunnel syndrome)
6. Known diabetes
7. Generalised pain syndromes such as fibromyalgia
8. Known peripheral neuropathies
9. Known allergies towards the interventions
10. Gastric bypass or other malabsorption syndrome
11. 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
12. 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
13. History of hand surgery in the target hand within 12 months prior to enrolment
14. History of arthroplasty, arthrodesis or surgical treatment of thumb base osteoarthritis in the target hand
Management strategies
15. Use of systemic corticosteroids equivalent of ≥ 7.5 mg prednisolone daily within 3 months
16. Treatment with denosumab (Prolia/Xgeva)
17. Participation in experimental device or experimental drug study 3 months prior to enrolment
18. Intra-articular treatments of any kind of any joint of the target hand 3 months before inclusion
19. Current use of synthetic or non-synthetic opioids
20. Planning to start other treatment for hand OA in the study participation period
21. Planned CT scan with iodine contrast
22. Scheduled surgery on upper extremity of the target hand during study participation
23. Scheduled surgery requiring pause of metformin, e.g. surgery in general anaesthesia, during study participation
Reproductive system
24. Pregnancy
25. 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
26. 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
27. 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)
28. Breast-feeding
Blood analysis
29. Positive anti-cyclic citrullinated peptide (\>10 kU/L)
30. eGFR \<60 ml/min/1.73 m2
31. Vitamin B12 deficiency \< 200 pmol/L
32. Hba1c ≥ 48 mmol/mol
18 Years
ALL
No
Sponsors
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Marius Henriksen
OTHER
Responsible Party
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Marius Henriksen
Professor
Locations
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The Parker Institute, Bispebjerg and Frederiksberg hospital
Copenhagen, Frederiksberg, Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2023-509181-38-00
Identifier Type: -
Identifier Source: org_study_id
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