METFORMIN HYDROCHLORIDE for Hand osteoarthritis | Osteoarthritis

Inclusion criteria

• {"criterion_text":"- Study participants will have a diagnosis of hand OA. Diagnosis will be confirmed by a medical doctor at baseline and participants must fulfil the American College of Rheumatology (ACR) criteria for hand OA (35): •\tHand pain, aching or stiffness on most days the previous 4 weeks And at least 3 of the following features: •\tHard tissue enlargement of ≥2 of the 10 selected joints* •\tHard tissue enlargement of ≥2 of the 10 DIP joints •\tFewer than 3 swollen metacarpophalangeal (MCP) joints •\tDeformity of at least 1 of 10 selected joints* *The 10 selected joints are the second and third DIP, the second and third PIP, and the first carpometacarpal joints of both hands."}
• {"criterion_text":"- Age ≥18 years"}
• {"criterion_text":"- Hand OA according to the ACR criteria above"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Metformin naive"}

Exclusion criteria

• {"criterion_text":"- A participant will be excluded from the study if he/she meets any of the following criteria listed below. Known diseases will be based on diagnosis registered in the participants health journal. If an exclusion diagnosis is suspected, necessary diagnostics will be performed before inclusion in the study. Comorbidities 1.\tHistory of, or current signs of medical disease that may affect joints, e.g. rheumatoid arthritis, gout, psoriatic arthritis"}
• {"criterion_text":"- 2.\tPsoriasis"}
• {"criterion_text":"- 3.\tKnown malignancy (except successfully treated squamous or basal cell skin carcinoma)"}
• {"criterion_text":"- 4.\tDrug or alcohol abuse in the last year"}
• {"criterion_text":"- 5.\tExisting nerve entrapment syndromes (e.g. carpal tunnel syndrome)"}
• {"criterion_text":"- 6.\tKnown diabetes"}
• {"criterion_text":"- 7.\tGeneralised pain syndromes such as fibromyalgia"}
• {"criterion_text":"- 8.\tKnown peripheral neuropathies"}
• {"criterion_text":"- 9.\tKnown allergies towards the interventions"}
• {"criterion_text":"- 10.\tGastric bypass or other malabsorption syndrome"}
• {"criterion_text":"- 11.\tIn 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"}
• {"criterion_text":"- 12.\tAny 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."}
• {"criterion_text":"- Surgical history 13.\tHistory of hand surgery in the target hand within 12 months prior to enrolment"}
• {"criterion_text":"- 14.\tHistory of arthroplasty, arthrodesis or surgical treatment of thumb base osteoarthritis in the target hand"}
• {"criterion_text":"- Management strategies 15.\tUse of systemic corticosteroids equivalent of ≥ 7.5 mg prednisolone daily within 3 months"}
• {"criterion_text":"- 16.\tTreatment with denosumab (Prolia/Xgeva)"}
• {"criterion_text":"- 17.\tParticipation in experimental device or experimental drug study 3 months prior to enrolment"}
• {"criterion_text":"- 18.\tIntra-articular treatments of any kind of any joint of the target hand 3 months before inclusion"}
• {"criterion_text":"- 19.\tCurrent use of synthetic or non-synthetic opioids"}
• {"criterion_text":"- 20.\tPlanning to start other treatment for hand OA in the study participation period"}
• {"criterion_text":"- 21.\tPlanned CT scan with iodine contrast"}
• {"criterion_text":"- 22.\tScheduled surgery on upper extremity of the target hand during study participation"}
• {"criterion_text":"- 23.\tScheduled surgery requiring pause of metformin, e.g. surgery in general anaesthesia, during study participation"}
• {"criterion_text":"- Reproductive system 24.\tPregnancy"}
• {"criterion_text":"- 25.\tPlanned 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"}
• {"criterion_text":"- 26.\tInsufficient anti-conception therapy for female fertile participants within the study period and 3 months after end of study treatment \tSufficient 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 \tFemale participants are considered infertile if they are postmenopausal or if they have undergone surgical sterilisation (bilateral salpingectomy, hysterectomy or bilateral oophorectomy) \tPostmenopausal state is defined as no menses for 12 months without alternative medical cause before inclusion in the study"}
• {"criterion_text":"- 27.\tInsufficient anti-conception therapy for male participants within the study period and 6 months after end of study treatment \tSufficient anti-conception therapy consists of condom or sexual abstinence \tMale participants are considered sterile if they have undergone surgical sterilisation (vasectomy)"}
• {"criterion_text":"- 28.\tBreast-feeding"}
• {"criterion_text":"- Blood analysis 29.\tPositive anti-cyclic citrullinated peptide (>10 kU/L)"}
• {"criterion_text":"- 30.\teGFR <60 ml/min/1.73 m2"}
• {"criterion_text":"- 31.\tVitamin B12 deficiency < 200 pmol/L"}
• {"criterion_text":"- 32.\tHba1c ≥ 48 mmol/mol"}

Primary endpoints

• {"endpoint_text":"- Change from baseline in VAS finger joint pain of the target hand after 16 weeks of treatment (at the week 17 visit).","definition_or_measurement_approach":"Change from baseline in VAS finger joint pain of the target hand measured at the week 17 visit (after 16 weeks of treatment) using a visual analogue scale (VAS)."}

Denmark

Earliest CTIS Part Ii Submission Date

19-03-2024

Latest Decision Or Authorization Date

12-06-2025

Processing Time Days

450

Number Of Sites

2

Number Of Participants

150

Primary sponsor

Full Name

Bispebjerg Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}