Clinical Trial on the Efficacy of Raloxifene on Disease Activity and Glucocorticoid-induced Osteoporosis in Postmenopausal Women With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 主要终点
- Evaluation of DAS-28 criteria
研究概览
简要总结
The investigators select 40 postmenopausal women suffering from RA with 2.5<DAS28<5.5 referring to rheumatology clinics of Mashhad university of medical sciences and randomly divide them into intervention group and placebo group. Evista tab 60mg/day and placebo are administered double blind. In the beginning, total bone mineral density (BMD) assessment is carried out from all patients and then Alendronate is discontinued in 2 groups. In first 3 months, in addition to Evista and placebo, MTX tab 2.5mg is given to patients and they are allowed to consume NSAID with accurate record of its dosage. Patients visit rheumatologist monthly in these 3 months and NSAID should be discontinued 48 hours before every visit. At the end of month 3, disease activity and probable complications are evaluated and compared in 2 groups. Classic regimen should be started for every patient who doesn't enter remission phase in first 3 months.
In 4th month, DMARD regimen is administered and then patients are visited every 2 months. Clinical findings are collected in month 0, 1, 2, 3, 6, 8, 10, 12. After 12 months, another total BMD test is carried out and then data are analyzed including changes in BMD, DAS28, EULAR response criteria and HAQ-DI score.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients are postmenopausal women.
- •Patients should fit at least 4 criteria of ACR-1987 criteria for rheumatoid arthritis.
- •Patients should be in range of 2.5 <DAS28-ESR <5.5
排除标准
- •Patients with history of thrombotic events
- •Patients suffering from another rheumatic diseases simultaneously
- •Patients with sever symptoms of menopause
- •Patients with known psychological diseases
研究组 & 干预措施
Evista
20 postmenopausal women suffering from rheumatoid arthritis that take raloxifene hydrochloride 60 mg oral tablets every day for one year.
干预措施: Raloxifene hydrochloride (Drug)
Placebo
20 postmenopausal women suffering from rheumatoid arthritis that take placebo pills every day for one year.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Evaluation of DAS-28 criteria
时间窗: 3 months
Assessing of complications
时间窗: 3 months
次要结局
- Complications(12 months)
- Assessing of Bone Marrow Density score(12 months)
- DAS-28 criteria(12 months)
- EULAR criteria(12 months)
- HAQ-DI criteria(12 months)
研究者
Sara Saeidi Shahri
Medical Student
Mashhad University of Medical Sciences
