For 12months, the Multi Center, Randomized, Open-label Comparative Clinical Study to Evaluate the Efficacy and the Safety of Monthly(RisenexM Group) Versus Weekly Oral Risedronate(Risenexsplus Group) With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women(Phase IV)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- The propotion of patients with 25(Oh)D level <20mg/ml of 12 months
研究概览
简要总结
The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) in Korean postmenopausal osteoporotic women(Phase IV)
详细描述
The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) with Vitamin D in compliance, improvement of vitaminD and BMD in Korean postmenopausal osteoporotic women(Phase IV)
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female osteoporosis patients over 19years of age(with menopause).
- •Definition of osteporosis
- •They had a BMD T-score -2.5 or less at mean Lumbar spine(L1~L4), Femoral neck or total. Or evidence of at least one vertebral fracture.
- •Definition of menopause(can be one of three condition)
- •For 12months spontaneous amenorrhea
- •For 6months spontaneous amenorrhea with serum FSH(Follicle stimulating hormone) is 40 mlIU/mL and over
- •6weeks after bilateral ovariectomy whether hysterectomy of not
- •Patients who can be treated with oral bisphosphonate drugs
- •Patients who have adequate to be measured DXA(Dual energy x-ray absorptiometry)
- •Patients who made a voluntary agreement after explanation of this study
- •Patients who participated in clinical trial(HL_RSNP_401) must have taken the Risenexplus and finish the study for 12 months.
排除标准
- •Patients with esophagus disorder.
- •Patients administered with osteoprosis therapy(except calcium,Vit.D medication) within previous 3 months
- •Patients with serum calcium concentrations 8.0mg/dL under.
- •Patients with severe nephropathy(serum creatinine> doulble of normal level
- •Patients with unable to sit upright or stand 30minutes.
研究组 & 干预措施
Risenex M
Patients who were treated with Resenex M (Risendronate/Cholecalciferol combination in one tablet) once a month for 12months
干预措施: Risedronate/Cholecalciferol combination(montly) (Drug)
Risenex Plus
Patients who were treated with Risenex plus (Risendronate/Cholecalciferol combination in one tablet) once a week for 12months
干预措施: Risedronate/Cholecalciferol combination(montly) (Drug)
Risenex Plus
Patients who were treated with Risenex plus (Risendronate/Cholecalciferol combination in one tablet) once a week for 12months
干预措施: Risedronate/Cholecalciferol combination(weekly) (Drug)
结局指标
主要结局
The propotion of patients with 25(Oh)D level <20mg/ml of 12 months
时间窗: 1 year
次要结局
- The change of Compliance - overall groups of Risenex plus vs Risenex M(1year)
- The change of 25(Oh)D level in patients.(6months,1year)
- The change of Bone Mineral Density(BMD) value(1year)
- The change of PTH(Parathyroid hormone value)(6months,1 year)