NCT00794443已完成2 期
A Multi-center Double-blind Parallel-group Comparison Study in Involutional Osteoporosis Patients to Examine the Efficacy and Safety of ONO-5920/YM529 Monthly Intermittent Formulation With Its Daily Formulation.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 692
- 主要终点
- Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method
研究概览
简要总结
This is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ONO-5920/YM529 with its daily formulation.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose bone mineral density is <70% of Young Adult Mean (YAM), or <80% of YAM who have fragile fracture history
- •Patients can walk on his/her own
- •Written informed consent has been obtained from the patient.
排除标准
- •Sequential osteoporosis patients or patients with other disorders showing low bone mass
- •Patients with the findings that influence measurement of lumbar vertebral bone mineral density by the DXA method
- •Patients who are unable to keep raising or standing for ≥30 min
- •Patients with peptic ulcer
- •Patients who have experienced anamnesis or gastrectomy (total extraction)
研究组 & 干预措施
1. Monthly - Dose 1
Experimental
Monthly intermittent administration, dose 1
干预措施: YM529 / ONO-5920 (Drug)
2. Monthly - Dose 2
Experimental
Monthly intermittent administration, dose 2
干预措施: YM529 / ONO-5920 (Drug)
3. Daily
Active Comparator
Daily administration
干预措施: YM529 / ONO-5920 (Drug)
结局指标
主要结局
Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method
时间窗: At the final evaluation point
次要结局
- Frequency of fracture(At the final evaluation point)
- Time-course changes in the total femoral bone mineral density by the DXA method(Through the treatment period)
- Assessment of adverse events, lab test values(Through the treatment period)
- Time-course changes in the percent change of bone metabolism markers(Through the treatment period)
研究者
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