Hand OsteoarthritisPhase 3METRONCT06367283
Metformin Treatment of Patients with Hand Osteoarthritis
A Phase 3 study testing Metformin in people with Hand Osteoarthritis, run by Marius Henriksen at 1 site in Denmark.
Trial summary
To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Jun 2024to Apr 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 during the study period
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
The Parker Institute, Bispebjerg and Frederiksberg hospital
Copenhagen, Frederiksberg, 2000
Kasper Staberg Madsen, MD, +4538164162, kasper.staberg.madsen@regionh.dk
About this study
Official title: Metformin Treatment of Patients with Hand Osteoarthritis: a Randomised, Placebo-controlled Trial
To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms.
- Conditions
- Hand Osteoarthritis
- Being tested
- Metformin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
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.
PlaceboDrug
Participants in the placebo group will receive a placebo tablet identical to the metformin tablet
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Not described Receives: Drug: Metformin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finger pain
Change from baseline in Visual Analogue Scale (VAS) finger joint pain of the target hand after 16 weeks of treatment
Measured: Week 16
Secondary outcomes (8)
Function
Change from baseline after 16 weeks of treatment in physical function assessed by Australian/Canadian Osteoarthritis Hand Index (AUSCAN) physical function subscale
Measured: Week 16
Thumb base pain
Change from baseline after 16 weeks of treatment in Visual Analogue Scale thumb base pain of the target hand
Measured: 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
Measured: 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
Measured: Week 16
Patient global assessment
Change from baseline after 16 weeks of treatment in Visual Analogue Scale patient global assessment
Measured: 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
Measured: Week 16
Hand strength
Change from baseline after 16 weeks of treatment in hand strength of the target hand assessed by a grip dynamometer
Measured: 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).
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start3 Jun 2024
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marius Henriksen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marius Henriksen, Frederiksberg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367283
- Sponsor's protocol ID
- 2023-509181-38-00
- Other IDs
- 2023
- Acronym
- METRO
- Status last verified
- Feb 2025
- First submitted
- 3 Apr 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing plan Individual participant data that underlie the results reported in this study and analytic code will be availa-ble from Henning Bliddal (henning.bliddal@regionh.dk) once all planned analyses have been completed and published. The request will be considered on individual basis. Consent for data sharing was not obtained, but the dataset is anonymised, and risk of reidentification is very low. The study protocol and statistical analysis plan are part of the manuscript. The informed consent form is available upon re-quest.
Publications
Madsen KS, Henriksen M, Dossing A, Poulsen AS, Oscar R, Kragstrup T, Ellegaard K, Knop FK, Boesen M, Hunter DJ, Christensen R, Bliddal H. Metformin treatment for patients with hand osteoarthritis: protocol for the multicentre, randomised, placebo-controlled METRO trial. BMJ Open. 2025 Mar 26;15(3):e093831. doi: 10.1136/bmjopen-2024-093831.
PubMed 40139705
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin Treatment of Patients with Hand Osteoarthritis: a Randomised, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06367283
- Acronym / sponsor ID
- METRO / 2023-509181-38-00
- Conditions
- Hand Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Marius HenriksenUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metformin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (42 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin 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. | Drug | Metformin |
| PlaceboParticipants in the placebo group will receive a placebo tablet identical to the metformin tablet | Drug | Placebo |
Primary outcome
Finger pain
Time frame: Week 16
Change from baseline in Visual Analogue Scale (VAS) finger joint pain of the target hand after 16 weeks of treatment
8 secondary outcomes
Function
Time frame: Week 16
Thumb base pain
Time frame: Week 16
Hand pain
Time frame: Week 16
Physician tender joint count
Time frame: Week 16
Patient global assessment
Time frame: Week 16
Quality of life assessed by the European Quality of life - 5 dimensions (EQ-5D) scale
Time frame: Week 16
Hand strength
Time frame: Week 16
Number of treatment responders
Time frame: Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Derived from this study: PubMed 40139705Madsen KS, Henriksen M, Dossing A, Poulsen AS, Oscar R, Kragstrup T, Ellegaard K, Knop FK, Boesen M, Hunter DJ, Christensen R, Bliddal H. Metformin treatment for patients with hand osteoarthritis: protocol for the multicentre, randomised, placebo-controlled METRO trial. BMJ Open. 2025 Mar 26;15(3):e093831. doi: 10.1136/bmjopen-2024-093831.
- Individual participant dataSharing planned: Yes. Data sharing plan Individual participant data that underlie the results reported in this study and analytic code will be availa-ble from Henning Bliddal (henning.bliddal@regionh.dk) once all planned analyses have been completed and published. The request will be considered on individual basis. Consent for data sharing was not obtained, but the dataset is anonymised, and risk of reidentification is very low. The study protocol and statistical analysis plan are part of the manuscript. The informed consent form is available upon re-quest.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin in people with Hand Osteoarthritis, run by Marius Henriksen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kasper Staberg Madsen (+4538164162, kasper.staberg.madsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Finger pain (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06367283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.