Randomized Clinical Trial on the Prevention of Radiographic Progression With Zoledronic Acid in Patients With Early Rheumatoid Arthritis and Low Disease Activity
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 28
- 试验地点
- 11
- 主要终点
- Sharp van der Heijde index
研究概览
简要总结
The progression of structural joint damage is the leading cause of disability and socioeconomic costs associated with rheumatoid arthritis (RA). Remission and low clinical activity not always imply absence of progression of structural damage. The main objective of this study is to evaluate the progression of radiological damage in early RA patients currently treated with disease modifying anti-rheumatic drugs (DMARDs) and low disease activity to which treatment with zoledronic acid is added.
The investigators propose a randomized clinical trial in 94 patients with RA of less than 2 years of evolution that, being treated with DMARDs, present criteria of low disease activity (DAS28 < 3.2).
Patients will be randomized into two branches: zoledronic acid and no treatment. The primary study endpoint is the progression of radiological damage assessed in a blinded way by the difference in the Sharp-van der Heijde index (SHI) in radiographs of hands and feet after two years; the secondary variables: radiographic progression after one year, serum bone biomarkers (OPG, RANKL, DKK-1 and sclerostin) and adverse effects. In a subgroup of patients, the investigators shall evaluate the change in the size of hand erosions by multislice computed tomography and the evolution of periarticular osteoporosis and systemic bone mass by dual X-ray absorptiometry (DXA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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 equal or greater than 18 years
- •Patients with RA of less than 2 years of evolution
- •DMARD therapy (methotrexate alone or methotrexate, leflunomide or methotrexate within COBRA strategy) on stable dose for at least 6 weeks prior to study entry
- •Patients not treated with glucocorticoids or under stable dose of prednisone up to 5 mg / day or equivalent dose of another glucocorticoid
- •Low disease activity (DAS28 <3.2)
- •In case of premenopausal women, commitment to make contraceptive treatment up to 3 years after the last dose of zoledronic acid
- •Signed informed consent
排除标准
- •Previous or current treatment with biological drugs used for the treatment of RA (infliximab, adalimumab, etanercept, certolizumab, golimumab, rituximab, abatacept, tocilizumab)
- •Pretreatment with:
- •Bisphosphonates in the 5 years prior to the onset of RA
- •Calcitonin, raloxifene, bazedoxifene, strontium ranelate, teriparatide and denosumab in the year before the onset of RA
- •Contraindication to treatment with zoledronic acid:
- •Hypersensitivity to bisphosphonates
- •Hypocalcemia
- •Glomerular filtration rate <35 mL / min
- •Pregnant (negative pregnancy test) and lactating women
- •Poor oral hygiene
- •Pending invasive dental procedure
- •Serum levels of calcidiol lower than 25 nmol/L (10 ng/mL).
- •Simultaneous participation in another clinical trial
研究组 & 干预措施
Zoledronic acid
Zoledronic acid: 5 mg/year x 2 years
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
Sharp van der Heijde index
时间窗: Two years
To assess the progression of radiographic damage in patients with early RA in current treatment with DMARDs and low disease activity to which treatment with zoledronic acid is added, compared to a no treatment control population, after two years.
次要结局
未报告次要终点
研究者
Carmen Gómez-Vaquero
MD PhD
Hospital Universitari de Bellvitge