A 24-week, International, Multi Centre, Randomised, Double-blind, Double-dummy, Parallel Group, Phase IV Clinical Trial Investigating Changes in Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) Treated With Either 100 µg PTH(1-84) Daily or 70 mg Alendronate Weekly
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Nycomed
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.
研究概览
简要总结
The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in reducing back pain intensity over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).
Secondly the objectives are to investigate any differences in patient reported outcomes between the two treatment arms over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).
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 (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with a T-score ≤ -1.5 SD and at least one osteoporosis related vertebral fracture. Chronic back pain.
排除标准
- •Previous/current treatment and medical history.
研究组 & 干预措施
PTH (1-84)
PTH (1-84) + placebo alendronate
干预措施: Parathyroid hormone (PTH) (1-84) (Drug)
Alendronate
PTH (1-84) placebo + alendronate
干预措施: Alendronate (Drug)
结局指标
主要结局
Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.
时间窗: Baseline and 24 weeks treatment
The daily patient assessment of intensity of back pain is based on the Numerical Rating Scale (NRS) which is an 11-point numerical rating scale (from 0-10 with 0 = "no pain" and 10 = "unendurable pain").
次要结局
- Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment(Baseline and 24 weeks treatment)