Using metformin to treat hand osteoarthritis symptoms

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

This study is testing if metformin can help people with hand osteoarthritis feel less pain and improve their symptoms over 16 weeks.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Frederiksberg University Hospital (Academic / other)
• Drugs / interventions: denosumab
• Locations: 1 site (Copenhagen, Frederiksberg)
• Trial ID: NCT06367283 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of metformin, administered at a dose of 2 grams daily or the maximum tolerated dose, compared to a placebo over a 16-week period for patients suffering from hand osteoarthritis. The study will enroll participants who meet specific criteria, including experiencing significant pain in their fingers and being naive to metformin treatment. The primary focus is to assess whether metformin can alleviate symptoms associated with this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with hand osteoarthritis and experience moderate to severe pain.

Not a fit: Patients with comorbid conditions such as rheumatoid arthritis, diabetes, or other significant medical issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from hand osteoarthritis, potentially improving their quality of life.

How similar studies have performed: While the use of metformin for osteoarthritis is not widely tested, there is emerging interest in repurposing existing medications for new indications, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years
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:

Comorbidities

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

Where this trial is running

Copenhagen, Frederiksberg

• The Parker Institute, Bispebjerg and Frederiksberg hospital — Copenhagen, Frederiksberg, Denmark (Recruiting)

Study contacts

• Study coordinator: Kasper Staberg Madsen

Conditions Hand Osteoarthritis