JPRN-jRCT2080222331已完成2 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 2 Study of ITM-058 in Patients with Postmenopausal Osteoporosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 164
研究概览
简要总结
Dependently on the dose of abaloparatide, lumbar spine (L1-L4 and L2-L4) BMD, femur (total) BMD, and osteogenesis marker levels increased as compared to the placebo. There were no clinically relevant findings or new safety concerns regarding safety.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 55age old 至 <= 85age old（—）
- 性别
- Female
入选标准
- •Patients with postmenopausal osteoporosis at high risk of fracture
排除标准
- •Patients who may be affected by the secondary osteoporosis
- •Patients who were treated with the drugs that may affect Calcium levels or bone metabolism
- •Patients with a history of osteosarcoma
研究者
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