JPRN-jRCT2080223520已完成3 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 3 Study of ITM-058 in Patients with Osteoporosis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 213
研究概览
简要总结
The percent change in lumbar (L1-L4) bone mineral density at the last visit, the abaloparatide group is statistically significant increases to compared to the placebo group in both the entire population of postmenopausal osteoporosis patients and male osteoporosis patients and the subpopulation of postmenopausal osteoporosis patients. 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
- All
入选标准
- •Patients with 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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