NCT00433160已完成3 期
Efficacy and Safety of LY333334 in Japanese Patients 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
- 207
- 试验地点
- 1
- 主要终点
- Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
研究概览
简要总结
To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese patients diagnosed with osteoporosis
- •Aged 55 or older
- •Patients who are at high risk for fracture
排除标准
- •History of metabolic bone disorders other than primary osteoporosis
- •History of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.
- •Severe or chronically disabling conditions other than osteoporosis
研究组 & 干预措施
Teriparatide
Experimental
20 micrograms for 104 weeks
干预措施: Teriparatide (Drug)
Placebo
Placebo Comparator
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
干预措施: Teriparatide (Drug)
Placebo
Placebo Comparator
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
时间窗: Baseline to 52 weeks
Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
次要结局
- Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)(Baseline to 52 Weeks)
- Percent Change in Bone Mineral Density (BMD) at Total Hip(Baseline to 52 Weeks)
- Percent Change in Bone Mineral Density (BMD) at Femoral Neck(Baseline to 52 Weeks)
- Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)(Baseline to Weeks 4, 12, 24, and 52)
- Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)(Baseline to Weeks 4, 12, 24, 52)
- Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)(Baseline to Weeks 4, 12, 24, 52)
- Vertebral Fractures by Central X-ray Assessment(Baseline through 52 weeks)
- Fractures by Investigators Assessment(Baseline through 52 Weeks)
- Back Pain Severity(Baseline, Weeks 12, 24, 36, 52)
- Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks(Baseline, 76 Weeks, 104 Weeks)
- Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks(Baseline, 76 Weeks, 104 Weeks)
- Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks(Baseline, 76 Weeks, 104 Weeks)
- Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks(Baseline, 76 Weeks, 104 Weeks)
- Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks(Baseline, 76 Weeks, 104 Weeks)
- Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks(Baseline, 76 Weeks, 104 Weeks)
- Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks(Baseline, 76 Weeks, 104 Weeks)
- Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks(Baseline through 104 Weeks)
- Fractures by Investigators Assessment During Entire Study Period of 104 Weeks(Baseline Through 104 Weeks)
- Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks(Baseline, 76 Weeks, 104 Weeks)
研究者
研究点 (1)
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