Comparison of the Clinical Efficacy and Safety Between Raloxifene and Bazedoxifene in Postmenopausal Women.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Effects of raloxifene vs. bazedoxifene on bone mineral density, bone turnover markers and bone quality markers in postmenopausal osteoporosis.
研究概览
简要总结
Although there are two kinds of selective estrogen receptor modulator (SERM) :raloxifene (RLX) and bazedoxifene (BZA), the difference is still unclear. In this study, we plan to compare clinical efficacy and safety between RLX and BZA.
详细描述
Selective estrogen receptor modulator (SERM) is an important option for postmenopausal osteoporosis. There are two SERM approved in Japan for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. One is raloxifene (RLX), and the other is bazedoxifene (BZA). There are few reports concerning to the clinical efficacy and safety data. In this study, we plan to compare clinical efficacy and safety between RLX and BZA.
The main objective of this study is to reveal the effects of RLX and BZA on bone mineral density, bone turnover markers, and bone quality markers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women
排除标准
- •Patients who could not use SERM
结局指标
主要结局
Effects of raloxifene vs. bazedoxifene on bone mineral density, bone turnover markers and bone quality markers in postmenopausal osteoporosis.
时间窗: Up to 72 months
The investigators plan to analyze 300 patients who undergo selective estrogen receptor modulator (SERM) treatments for five years. We investigate the efficacy of two SERMs: raloxifene (RLX) and bazedoxifene (BZA). Bone mineral density (BMD) andd laboratory analyses (bone markers, routine chemistry, urine, and bone quality marker of pentosidine) at baseline and every four to six months. We also investigate the side effects. Statical analyses are performed using Spearman correlation coefficients, paired t-test, Mann-Whitney U test, chi-square test and Fisher's exact test to compare the efficacy and safy between RLX and BZA.
次要结局
未报告次要终点
研究者
Toshihiko Kono
Head of Hospital
Tomidahama Hospital