Comparison of Raloxifene and Strontium Ranelate on Compliance and Efficacy in Women With Postmenopausal Osteoporosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis
研究概览
简要总结
The purpose of this study was to compare compliance and efficacy of raloxifene and strontium ranelate in a group of women with postmenopausal osteoporosis.
详细描述
OBJECTIVE
To compare the performance of raloxifene and strontium rannelate in the management of women with postmenopausal osteoporosis.
DESIGN: Prospective, open label study. SETTING: University hospital menopause unit. PATIENTS: 80 women with postmenopausal osteoporosis were assigned to either raloxifene (60 mg/d) or strontium ranelate (2g/d). Participants were followed for 1 year.
MAIN OUTCOME MEASURE(S): Compliance with each regime. Secondary objectives were parameters of efficacy, including changes in bone mineral density and bone biochemical markers.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women with densitometric osteoporosis
排除标准
- •Secondary osteoporosis
研究组 & 干预措施
raloxifene
60 mg/d for one year.
干预措施: Raloxifene (Drug)
strontium ranelate
2 g/d for one year.
干预措施: Strontium ranelate (Drug)
结局指标
主要结局
Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis
时间窗: One year
Primary Outcome measure: compliance. Assessment of compliance assessed two variables, the number of participants maintaining treatment after one year and, among those that completed the one year treatment, the number of them that completed at least 80% of the prescribed dose.
次要结局
- Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis(One year)
研究者
Antonio Cano Sanchez
Professor in Obstetrics and Gynecology
University of Valencia