NCT06079476已完成4 期
An Open-label, Single-arm, Multicenter Phase 4 Study to Evaluate Safety and Tolerability of Romosozumab (EVENITY® ) in Postmenopausal Women in India With Osteoporosis and a High Risk of Fracture.
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Number of Participants Experiencing Clinically Significant Changes in Laboratory Assessments
研究概览
简要总结
The primary objective of this study is to characterize safety and tolerability of romosozumab in postmenopausal women with osteoporosis and a high risk of fracture in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with osteoporosis who are postmenopausal and have a high risk of fracture who provided inform consent (in-person or through their legally authorized representative) to participate in the use of romosozumab per local label in India.
排除标准
- •Participants who experienced myocardial infarction or stroke within a year prior to entering this study.
研究组 & 干预措施
Phase 4: Romosozumab
Experimental
Participants will be dosed with two subcutaneous (SC) injections of romosozumab once a month for 12 months.
干预措施: Romosozumab (Drug)
结局指标
主要结局
Number of Participants Experiencing Clinically Significant Changes in Laboratory Assessments
时间窗: Baseline, Month 12
Number of Participants With Clinically Significant Changes in Vital Signs
时间窗: Baseline, Month 12
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
时间窗: Up to 12 months
Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAE)
时间窗: Up to 12 months
次要结局
- Percentage Change From Baseline in BMD (Measured by DXA) of the Total Hip(At 6 months and 12 months)
- Percentage Change From Baseline in Bone Mineral Density (BMD) (Measured by Dual-energy X-ray Absorptiometry [DXA]) of the Lumbar Spine(At 6 months and 12 months)
- Percentage Change From Baseline in BMD (Measured by DXA) of the Femoral Neck(At 6 months and 12 months)
研究者
研究点 (10)
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