JPRN-jRCT1080221967已完成4 期
The post-marketing clinical randomized study of eldecalcitol on fall-related physical performance in Japanese osteoporotic patients with frailty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 124
研究概览
简要总结
A randomized, open-label, controlled clinical trial has been conducted with 124 female patients aged 65 or over with osteoporosis. Patients were randomly assigned to receive either 0.75 mcg of ELD once-a-day or 35 mg of ALN once-a-week for 24 weeks. The primary endpoint was the change in a postural balance index, adjusted composite equilibrium score (CES) of sensory organization test (SOT). There was no statistically significant difference between the two groups.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 65age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •Osteoporosis patients with normal walking speed is within between 0.5m/sec and 1.2m/sec.
排除标准
- •Patients: those take psychotropic agents, or anabolic agents, etc., and those physical performances are diagnosed to be influenced by above agents. Patients received agents that affect bone metabolism within 8 weeks before the treatment start.
- •Patients with disease(s) accompanied by high risk of falls except for osteoporosis.
- •Patients with disease(s) characterized by low bone mass except for osteoporosis.
研究者
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