NCT00358176已完成3 期
A Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Noninferiority Study Comparing 75mg Risedronate Dosed on 2 Consecutive Days Monthly With 5mg Daily Risedronate in the Treatment of Postmenopausal Osteoporosis as Assessed Over 24 Months.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,231
- 试验地点
- 11
- 主要终点
- Percent change from baseline in lumbar spine bone mineral density (BMD) at
研究概览
简要总结
To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis.
To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption.
To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects meeting all of the following criteria were considered for enrollment into the study :
- •·Ambulatory, healthy postmenopausal women with :
- •Natural menopause and more than 5 years after their last menstrual period.
- •Or surgical menopause and more than 5 years after surgery (blood hormone tests required for subjects less than 65 years of age who had uterus removed without removal of ovaries at time of surgery).
- •Osteoporosis (lumbar spine T-score more than 2.5 SD below the mean value in normal young women or more than 2.0 SD below the mean value in normal young women and at least 1 fracture of a vertebra (thoracic-lumbar T4-L4)).
排除标准
- •Subjects with any of the following criteria were not considered for enrollment into the study :
- •·Women who have received hormone replacement therapy (with estrogen by mouth and/or progestogen and/or androgen) or raloxifene, or other bone active drugs, such as calcitonin, calcitriol/calcidiol/alfacalcidol, parathyroid hormone or any bisphosphonate within 3 months before first dose of study medication.
结局指标
主要结局
Percent change from baseline in lumbar spine bone mineral density (BMD) at
Month 12 measured by dual-energy X-ray absorptiometry (DXA).
次要结局
- Efficacy:Percent change from baseline in Lumbar spine BMD at times other than Month 12, Proximal femur BMD and Bone turnover markers.
- Physical examination before treatment and after 12 and 24 months of treatment.
- Safety: AEs, clinical laboratory values, bone biopsies.
- Intact serum parathyroid hormone (PTH 1-84)before treatment and after 3, 12 and 24 months of treatment in approximately 25% of randomly selected trial participants.
研究者
研究点 (11)
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