Antiresorptive Effects of a 6-m Treatment Course With Ibandronate Plus Supplementation of Vitamine D and Calcium in Central America
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 425
- 试验地点
- 1
- 主要终点
- Bone Mineral Density
研究概览
简要总结
Ibandronate is a third-generation biphosphonate with recognized antiresorptive efficacy by several international, randomized, double-blind, controlled trials. These studies have not included patients from central america, to the best of our knowledge. Therefore, this open-label, uncontrolled study, was set out to assess the clinical effects of a 6-m treatment course with Ibandronate plus vitamine D and Calcium on bone mineral density and health-related quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a diagnosis of osteoporosis of at-Risk
- •Have a medical indication to receive Ibandronate+Vitamine D+Calcium
排除标准
- •Osteoporosis due to secondary causes
研究组 & 干预措施
patients on antiresorptive therapy
Ibandronate 150 mg per month + Vitamine D 400-800 IU and Calcium 500-1000 mg per day
干预措施: antiresorptive therapy (Drug)
结局指标
主要结局
Bone Mineral Density
时间窗: 6 months
Health-Related Quality of Life
时间窗: 6 months
次要结局
- Adverse Events(6 months)
研究者
Santiago Perez Lloret
Associate Researcher
Pontifical Catholic University of Argentina