NCT00365456已完成3 期
An Open Label, International, Multi Centre, Parallel Group, Phase III b, Randomised Trial, Investigating Lumbar Spine Bone Mineral Density (BMD) Changes in Postmenopausal Women With Primary Osteoporosis Initially Treated With 12 Months of Full Length Parathyroid Hormone (PTH 1-84) Followed by 12 Months of Treatment With Risedronate Followed by Either 12 Months Treatment With PTH (1-84) or Risedronate.
Takeda0 个研究点目标入组 407 人开始时间: 2006年7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
- 407
- 主要终点
- Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.
研究概览
简要总结
The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12 months treatment with risedronate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Women above the age of 50 years with the diagnosis of postmenopausal primary osteoporosis may be enrolled in the trial if the following inclusion/exclusion criteria apply.
- •All inclusion criteria must be answered "yes" for a subject to be enrolled in the trial.
- •Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject).
- •Is the subject above 50 years old?
- •Is the subject postmenopausal (more than 5 years) - in the judgement of the investigator?
- •Does the subject have primary osteoporosis with a lumbar spine T score < -3.0 SD (at lumbar spine L1-L4, with a minimum of two evaluable vertebrae)?
- •Does the subject have a life expectancy of >3 years?
- •Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a helper)?
排除标准
- 未提供
研究组 & 干预措施
PTH (1-84)
Experimental
干预措施: Parathyroid Hormone (PTH) (Drug)
Risedronate
Active Comparator
干预措施: Risedronate (Drug)
结局指标
主要结局
Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.
时间窗: 12 months
BMD was measured by Dual X-ray Absorptiometry (DXA).
次要结局
未报告次要终点
研究者
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