NCT06367283招募中3 期
Metformin Treatment of Patients with Hand Osteoarthritis: a Randomised, Placebo-controlled Trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Finger pain
研究概览
简要总结
To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Comorbidities
- •History of, or current signs of medical disease that may affect joints, e.g. rheumatoid arthritis, gout, psoriatic arthritis
- •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 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
- •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
研究组 & 干预措施
Metformin
Experimental
干预措施: Metformin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Finger pain
时间窗: Week 16
Change from baseline in Visual Analogue Scale (VAS) finger joint pain of the target hand after 16 weeks of treatment
次要结局
- Function(Week 16)
- Thumb base pain(Week 16)
- Hand pain(Week 16)
- Physician tender joint count(Week 16)
- Patient global assessment(Week 16)
- Quality of life assessed by the European Quality of life - 5 dimensions (EQ-5D) scale(Week 16)
- Hand strength(Week 16)
- Number of treatment responders(Week 16)
研究者
Marius Henriksen
Professor
Frederiksberg University Hospital
研究点 (1)
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