The Assessment of Osteoporosis Treatment in Post-menopausal Women
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Brain-derived neurotrophic factor
研究概览
简要总结
The study will be conducted to assess the depressive symptoms and related markers in the postmenopausal female after anti-osteoporosis treatment.
详细描述
Fracture is one of the important complications in female. Osteoporosis should be treated in postmenopausal female due to high risk of fracture. Recently, there have been many classes of medications developed for preventing bone loss. Raloxifene, an oral form of anti-osteoporosis medication, has been reported to improved central nervous disorders. Therefore, this study is designed to assess the depressive symptoms and related markers in the postmenopausal female after anti-osteoporosis treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal female
- •Osteoporosis
排除标准
- •Psychological disorders
研究组 & 干预措施
Raloxifene group
Raloxifene treatment
干预措施: Raloxifene (Drug)
Comparator group
Alendronate treatment
干预措施: Alendronate (Drug)
结局指标
主要结局
Brain-derived neurotrophic factor
时间窗: 3 months
Serum brain-derived neurotrophic factor (BDNF) Levels
次要结局
- Body components(3 months)
- Vascular cell adhesion molecule-1(3 months)
- The Mini Mental State Examination (MMSE)(3 months)
- The Barthel index(3 months)
- ankle-brachial index(3 months)
- Brain-derived neurotrophic factor(1 year)
- 5-Item Geriatric Depression Scale(3 months)
- Orexin-A(3 months)
- Instrumental Activities of Daily Living (IADL)(3 months)
- Zung self-rating depression scale(3 months)