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New treatment option for Hand Osteoarthritis
Official title Metformin Treatment of Patients with Hand Osteoarthritis
ClinicalTrials.gov ID: NCT06367283
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as an once-daily, being studied as a potential treatment for hand osteoarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- Hand OA according to the ACR criteria
- 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
- Metformin naive
You likely can't join if
- Comorbidities
- History of, or current signs of medical disease that may affect joints, e.g. rheumatoid arthritis, gout, psoriatic arthritis
- Psoriasis
- Known malignancy (except successfully treated squamous or basal cell skin carcinoma)
- Drug or alcohol abuse in the last year
- Existing nerve entrapment syndromes (e.g. carpal tunnel syndrome)
See the full eligibility criteria
- Age ≥18 years
- Hand OA according to the ACR criteria
- 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
- Metformin naive
- Comorbidities
- History of, or current signs of medical disease that may affect joints, e.g. rheumatoid arthritis, gout, psoriatic arthritis
- Psoriasis
- Known malignancy (except successfully treated squamous or basal cell skin carcinoma)
- Drug or alcohol abuse in the last year
- Existing nerve entrapment syndromes (e.g. carpal tunnel syndrome)
- Known diabetes
- Generalised pain syndromes such as fibromyalgia
- Known peripheral neuropathies
- Known allergies towards the interventions
- Gastric bypass or other malabsorption syndrome
- 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...
- 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
- History of hand surgery in the target hand within 12 months prior to enrolment
- History of arthroplasty, arthrodesis or surgical treatment of thumb base osteoarthritis in the target hand Management strategies
- Use of systemic corticosteroids equivalent of ≥ 7.5 mg prednisolone daily within 3 months
- Treatment with denosumab (Prolia/Xgeva)
- Participation in experimental device or experimental drug study 3 months prior to enrolment
- Intra-articular treatments of any kind of any joint of the target hand 3 months before inclusion
- Current use of synthetic or non-synthetic opioids
- Planning to start other treatment for hand OA in the study participation period
- Planned CT scan with iodine contrast
- Scheduled surgery on upper extremity of the target hand during study participation
- Scheduled surgery requiring pause of metformin, e.g. surgery in general anaesthesia, during study participation Reproductive system
- Pregnancy
- 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
- 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
- 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)
- Breast-feeding Blood analysis
- Positive anti-cyclic citrullinated peptide (\>10 kU/L)
- eGFR \<60 ml/min/1.73 m2
- Vitamin B12 deficiency \< 200 pmol/L
- Hba1c ≥ 48 mmol/mol
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Frederiksberg, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Frederiksberg, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.