Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06367283

Metformin Treatment of Patients with Hand Osteoarthritis

Led by Marius Henriksen · Updated on 2025-02-27

150

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Metformin Treatment of Patients with Hand Osteoarthritis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Hand osteoarthritis diagnosed according to the ACR criteria
  • Average finger pain of 4 or higher on a 0-10 numeric rating scale over the past 30 days
  • Have not previously taken metformin
Not Eligible

You will not qualify if you...

  • History or current signs of medical diseases affecting joints such as rheumatoid arthritis, gout, or psoriatic arthritis
  • Presence of psoriasis
  • Known malignancy except successfully treated skin carcinoma
  • Drug or alcohol abuse within the last year
  • Existing nerve entrapment syndromes like carpal tunnel syndrome
  • Known diabetes
  • Generalised pain syndromes such as fibromyalgia
  • Known peripheral neuropathies
  • Known allergies to study interventions
  • History of gastric bypass or malabsorption syndrome
  • Use of pharmacological weight loss or osteoporosis medication unless stable for 3 months without planned dose changes
  • Any condition or impairment making participation unsuitable
  • History of hand surgery on the target hand within 12 months prior to enrollment
  • History of arthroplasty, arthrodesis, or surgical treatment of thumb base osteoarthritis in the target hand
  • Use of systemic corticosteroids equivalent to 7.5 mg or more prednisolone daily within 3 months
  • Treatment with denosumab
  • Participation in experimental drug or device studies within 3 months
  • Intra-articular treatment in the target hand joints within 3 months
  • Current use of synthetic or non-synthetic opioids
  • Planning to start other hand osteoarthritis treatments during the study
  • Planned CT scan with iodine contrast
  • Scheduled surgery on the upper extremity of the target hand during the study
  • Scheduled surgery requiring pausing metformin during the study
  • Pregnancy or planned pregnancy during the study and specified follow-up periods
  • Insufficient contraception for fertile female or male participants during the study and follow-up
  • Breastfeeding
  • Positive anti-cyclic citrullinated peptide above 10 kU/L
  • Kidney function estimated glomerular filtration rate below 60 ml/min/1.73 m2
  • Vitamin B12 deficiency below 200 pmol/L
  • HbA1c 48 mmol/mol or higher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Parker Institute, Bispebjerg and Frederiksberg hospital

Copenhagen, Frederiksberg, Denmark, 2000

Actively Recruiting

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Research Team

K

Kasper Staberg Madsen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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