To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
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.
Participants in the placebo group will receive a placebo tablet identical to the metformin tablet
The Parker Institute, Bispebjerg and Frederiksberg hospital
Copenhagen, Frederiksberg, Denmark
RECRUITINGFinger pain
Change from baseline in Visual Analogue Scale (VAS) finger joint pain of the target hand after 16 weeks of treatment
Time frame: Week 16
Function
Change from baseline after 16 weeks of treatment in physical function assessed by Australian/Canadian Osteoarthritis Hand Index (AUSCAN) physical function subscale
Time frame: Week 16
Thumb base pain
Change from baseline after 16 weeks of treatment in Visual Analogue Scale thumb base pain of the target hand
Time frame: Week 16
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
Time frame: Week 16
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
Time frame: Week 16
Patient global assessment
Change from baseline after 16 weeks of treatment in Visual Analogue Scale patient global assessment
Time frame: Week 16
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
Time frame: Week 16
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Hand strength
Change from baseline after 16 weeks of treatment in hand strength of the target hand assessed by a grip dynamometer
Time frame: Week 16
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).
Time frame: Week 16