Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06367283
Other study ID # 2023-509181-38-00
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 2024
Est. completion date April 2026

Study information

Verified date May 2024
Source Frederiksberg University Hospital
Contact Kasper Staberg Madsen
Phone +4538164162
Email kasperstabergmadsen@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date April 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark The Parker Institute, Bispebjerg and Frederiksberg hospital Copenhagen Frederiksberg

Sponsors (1)

Lead Sponsor Collaborator
Marius Henriksen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Stiffness of both hands Change in stiffness of both hands measured on the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) stiffness subscale Week 16
Other Composite of pain, function and stiffness Change in pain, function and stiffness of both hands measured composite on the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) Hand Index Score Week 16
Other Physical function Change in physical function of both hands assessed by the Health Assessment Questionnaire Disability Index (HAQ-DI) Week 16
Other Physician global assessment Change in physician global assessment of disease activity of hand OA in the target hand measured on a Visual Analogue Scale (VAS) scale Week 16
Other Swollen joint count Change in physician swollen joint count of the target hand Week 16
Other Fatigue Change in fatigue measured on a Visual Analogue Scale (VAS) scale Week 16
Other Sleep quality Change in sleep quality measured on the Pittsburgh Sleep Quality Index (PSQI) Week 16
Other Absence or presence of inflammation of target hand Change in absence or presence of inflammation of the target hand as measured by ultrasound (US) Week 16
Other Change in use of analgesics Change in use of analgesics measured as the use of paracetamol and NSAIDS Week 16
Other Inflammatory biomarker Change in hsCRP mg/L Week 16
Other Metabolic outcomes Change in HbA1c mmol/mol Week 16
Other Metabolic outcomes Change in lipids mmol/L Week 16
Other Vitamin K Change in vitamin K and dephospho-uncarboxylated matrix Gla-protein ((dp)ucMGP) pmol/L Week 16
Other Proteomics Change in mass-spectrometry based proteomics Week 16
Primary Finger pain Change from baseline in Visual Analogue Scale (VAS) finger joint pain of the target hand after 16 weeks of treatment Week 16
Secondary Function Change from baseline after 16 weeks of treatment in physical function assessed by Australian/Canadian Osteoarthritis Hand Index (AUSCAN) physical function subscale Week 16
Secondary Thumb base pain Change from baseline after 16 weeks of treatment in Visual Analogue Scale thumb base pain of the target hand Week 16
Secondary Hand pain Change from baseline after 16 weeks of treatment in pain of both hands assessed by Australian/Canadian Osteoarthritis Hand Index hand pain subscale Week 16
Secondary Physician tender joint count Change from baseline after 16 weeks of treatment in joint activity of the target hand assessed by physician tender joint count Week 16
Secondary Patient global assessment Change from baseline after 16 weeks of treatment in Visual Analogue Scale patient global assessment Week 16
Secondary Quality of life assessed by the European Quality of life - 5 dimensions (EQ-5D) scale Change from baseline after 16 weeks of treatment in quality of life assessed by the European Quality of life - 5 dimensions scale Week 16
Secondary Hand strength Change from baseline after 16 weeks of treatment in hand strength of the target hand assessed by a grip dynamometer Week 16
Secondary Number of treatment responders Responders will be identified according to OMERACT-OARSI criteria, defined as (1) improvement in finger pain (primary outcome) or function (secondary outcome) =50% and an absolute change =20 mm; or (2) improvement of =20% with an absolute change =10 mm in at least two of the following three: finger pain (primary outcome), function (secondary outcome), and patient global assessment (secondary outcome). Week 16
See also
  Status Clinical Trial Phase
Completed NCT02612233 - Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin Phase 4
Completed NCT01910116 - Efficacy of Shinabro in Hand Osteoarthritis Phase 2/Phase 3
Completed NCT01249391 - Splinting to Treat Hand Osteoarthritis Phase 2
Recruiting NCT04402047 - Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis N/A
Completed NCT03911570 - Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis
Completed NCT04576403 - Heated Mittens for Patients With Hand Osteoarthritis N/A
Completed NCT01874067 - C-GLOVES: the Effectiveness of Compression Gloves in Arthritis
Completed NCT02528630 - Progressive Strength in Hand Osteoarthritis Phase 4
Suspended NCT03703934 - Central Pain Mechanisms in Patients With Hand-Osteoarthritis, Psoriatic Arthritis and Healthy Controls
Completed NCT04585113 - Diagnostic Accuracy of Dual-energy CT
Completed NCT05568875 - Happy Hands - an E-self-management Intervention for People With Hand Osteoarthritis N/A
Completed NCT03693833 - CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis. Phase 2
Completed NCT05150171 - Happy Hands E-self-management Pilot Study N/A
Completed NCT02667145 - Assistive Device for Hand Osteoarthritis N/A
Completed NCT02477059 - Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Patients With Hand Osteoarthritis Phase 3
Recruiting NCT04611347 - Topical CBD in Joint Arthritis Phase 2
Completed NCT04036929 - Can we Use Estrogen-containing Therapy to Improve Pain in Women After Menopause With Hand Osteoarthritis? N/A
Completed NCT03919279 - Treatment of Erosive Digital Osteoarthritis by Transcutaneous Auricular Nerve Stimulation N/A
Recruiting NCT06329219 - Water-filtered Infrared-A Radiation in Patients With Hand Osteoarthritis N/A
Not yet recruiting NCT05216757 - Efficacy and Safety of Iguratimod in Patients With Hand Osteoarthritis (ESIGO) Phase 2/Phase 3