NCT01675297已完成4 期
For 12months, the Multi Center, Randomized, Open-label, Active Controlled Comparative Clinical Study to Assess the Efficacy and the Safety of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,053
- 试验地点
- 1
- 主要终点
- The Change of Bone Mineral Density (BMD) Value
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis.
详细描述
The purpose of this study is to evaluate the efficacy and the safety of Risedronate with and without cholecalciferol on vitamin D status, Bone Mineral Density (BMD) and bone markers.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Male osteoporosis patients over 19 years of age
- •Female osteoporosis patients with menopause
- •Definition of osteoporosis
- •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 40mlU/mL and over
- •6weeks after bilateral ovariectomy whether hysterectomy or not.
排除标准
- •Patients with esophagus disorder (i.e:esophagostenosis)
- •Patients administered with osteoporosis therapy(except calcium, Vit.D medication)within the previous 3 Months
- •Patients with serum calcium concentrations 8.0mg under
- •Patients with severe nephropathy (CCr 30mL/min less)
- •Patients with unable to sit upright or stand for 30minutes
研究组 & 干预措施
Risendronate/Cholecalciferol combination
Experimental
Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months
干预措施: Risedronate/Cholecalciferol combination (Drug)
Risedronate
Active Comparator
Sedron tablet: one tablet once a week for 12months
干预措施: Risedronate (Drug)
结局指标
主要结局
The Change of Bone Mineral Density (BMD) Value
时间窗: baseline and 12 months
Higher Bone Mineral Density(BMD) value mean a better outcome.
次要结局
- The Change of 25OHD(25-hydroxyvitamin D)(baseline, 6months, 12months)
- PTH(Parathyroid Hormone Value)(baseline, 6months, 12months)
研究者
研究点 (1)
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