Metformin Treatment of Patients with Hand Osteoarthritis

Launched by MARIUS HENRIKSEN · Apr 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of metformin, a medication commonly used for diabetes, in treating symptoms of hand osteoarthritis (OA). The goal is to see if taking metformin daily for 16 weeks can help reduce pain and improve hand function in patients with hand OA. Participants will be compared to a group taking a placebo, which is a dummy treatment with no active medication.

To be eligible for this trial, participants must be at least 18 years old and have hand OA with a pain level of 4 or higher on a scale of 0 to 10 over the past month. They should not have used metformin before. Certain health conditions, like rheumatoid arthritis or diabetes, as well as recent surgeries on the hand, may disqualify someone from participating. If eligible, participants can expect to take either metformin or a placebo for the duration of the study, and they will be monitored for any changes in their symptoms. This trial is currently recruiting participants of all genders aged 18 and older, and it's a great opportunity for those looking for new treatment options for hand OA.

Gender

ALL

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