NCT00239889已完成4 期
Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Grip strength of the injured arm after 24 weeks
研究概览
简要总结
Calcitonin has been used for many years for treating osteoporosis in postmenopausal women, and it has been shown that calcitonin reduces pain after spine and hip fracture in women with osteoporosis. Therefore, this study assesses the safety and efficacy of salmon calcitonin nasal spray on muscle strength after a forearm fracture, pain, quality of life and fracture healing in postmenopausal women.
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
- Double
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women, aged at least 60 years old
- •Having a forearm fracture within the last 3-7 days before treatment
- •Fracture is treated with either a plaster cast only, or a cast plus Kirschner wires
排除标准
- •Multiple fractures, severe fractures, or the forearm fractured in more than one place
- •Nerve damage in the forearm caused by the fracture
- •Other conditions which would interfere with the grip strength measurements (e.g. swelling, paralysis, skin diseases or rheumatoid arthritis)
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Grip strength of the injured arm after 24 weeks
次要结局
- Post fracture pain intensity at rest in the evenings and analgesic consumption over 24 hours at Days 1-7; weeks 2, 3 and 4; the day before cast removal; 1 to 7 days and 2, 4 and 10 weeks after cast removal; and at 24 weeks after enrolment.
- Post fracture pain intensity after grip strength assessment at cast removal; at 1, 2, 4 and 10 weeks after cast removal (4-6 weeks after fracture); and at 24 weeks after enrolment.
- Incidence of complex regional pain syndrome (CRPS) type 1/reflex sympathetic dystrophy (RSD) at cast removal; at 1, 2, 4 and 10 weeks after cast removal; and at 24 weeks after enrolment.
- Grip strength in the injured arm at cast removal and at 1, 2, 4 and 10 weeks after cast removal.
研究者
研究点 (2)
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