NCT00414973已完成3 期
Comparison of Teriparatide and Calcitonin in the Treatment of Men and Postmenopausal Women With Osteoporosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women
研究概览
简要总结
The purpose of this study is to compare the effect of injectable teriparatide to intranasal salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients with established osteoporosis
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
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of osteoporosis
- •No other severe disabling conditions
- •Should have at least 1 vertebral or non-vertebral prevalent fracture, and bone mineral density T-score should be less than -2.5
- •Ambulatory
- •Men (aged 40 to 85 years) or postmenopausal women (aged 55 to 85 years)
排除标准
- •History of a disease that affects bone metabolism
- •History of treatment with any drug that may significantly affect bone metabolism
- •History or presence of liver disease
- •History or presence of kidney disease
- •History of excessive alcohol drinking or drug abuse
研究组 & 干预措施
A
Experimental
干预措施: Teriparatide (Drug)
B
Active Comparator
干预措施: Salmon Calcitonin (Drug)
结局指标
主要结局
Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women
时间窗: Baseline to 24 weeks
Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
次要结局
- Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women(Baseline to 24 weeks)
- Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women(Baseline to 12 weeks and 24 weeks)
- Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men(Baseline to 24 weeks)
- Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men(Baseline to 24 weeks)
- Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men(Baseline to 12 weeks and 24 weeks)
研究者
研究点 (1)
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