NCT01581320已完成3 期
A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R206 and Bonviva for the Improvement of Vitamin D in Postmenopausal Women With Osteoporosis
Alvogen Korea1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- A ratio of subject whose 25 OHD concentration is less than 15ng/mL
研究概览
简要总结
A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to evaluate the efficacy and safety of Dp-R206 and Bonviva for 16 weeks once a month on the improvement of vitamin D in postmenopausal women with osteoporosis.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female more than 40 years old in postmenopausal
排除标准
- •Subject who has a history of malignant cancer
研究组 & 干预措施
DP-R206
Experimental
干预措施: Test group (Drug)
Bonviva
Active Comparator
干预措施: Reference group (Drug)
结局指标
主要结局
A ratio of subject whose 25 OHD concentration is less than 15ng/mL
时间窗: 16weeks
A ratio of subject whose 25 OHD concentration is less than 15ng/mL after 16weeks
次要结局
- A ratio of subject whose 25 OHD concentration is less than 9ng/mL(16 weeks)
- Safety evaluation (AE, Lab test, Vital sign etc)(16weeks)
研究者
研究点 (1)
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