A 12-Month Extension to: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Once Weekly Alendronate and Risedronate on Bone Mineral Density in Postmenopausal Women With Osteoporosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,053
- 主要终点
- Mean percent change from baseline in hip trochanter BMD at 24 months
研究概览
简要总结
This study is to evaluate and compare the effects of Alendronate and Risedronate to treat women with postmenopausal osteoporosis. The primary hypothesis for this study is that in postmenopausal women with osteoporosis, treatment with oral alendronate 70 mg once weekly will produce a mean percent increase from baseline in hip trochanter bone mineral density (BMD) at 12 and 24 months which is greater than that observed with oral risedronate 35 mg once weekly.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with postmenopausal osteoporosis
排除标准
- •Bilateral hip replacements
- •Esophageal abnormalities
- •Metabolic bone disease (example - Vitamin D deficiency)
- •Medications that would affect the breakdown or build-up of bone turnover
研究组 & 干预措施
Alendronate 70 mg
Alendronate sodium, 70 mg, orally once weekly for up to 24 months
干预措施: Alendronate (Drug)
Alendronate 70 mg
Alendronate sodium, 70 mg, orally once weekly for up to 24 months
干预措施: Elemental Calcium (Dietary Supplement)
Alendronate 70 mg
Alendronate sodium, 70 mg, orally once weekly for up to 24 months
干预措施: Vitamin D (Dietary Supplement)
Alendronate 70 mg
Alendronate sodium, 70 mg, orally once weekly for up to 24 months
干预措施: Risendronate placebo (Drug)
Risendronate 35 mg
Risendronate, 35 mg, orally once weekly for up to 24 months
干预措施: Risedronate 35 mg (Drug)
Risendronate 35 mg
Risendronate, 35 mg, orally once weekly for up to 24 months
干预措施: Elemental Calcium (Dietary Supplement)
Risendronate 35 mg
Risendronate, 35 mg, orally once weekly for up to 24 months
干预措施: Vitamin D (Dietary Supplement)
Risendronate 35 mg
Risendronate, 35 mg, orally once weekly for up to 24 months
干预措施: Alendronate placebo (Drug)
结局指标
主要结局
Mean percent change from baseline in hip trochanter BMD at 24 months
时间窗: Baseline and 24 months
Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months
时间窗: Baseline and 12 months
次要结局
- Number of participants who experienced one or more adverse events (AE)(Up to 24 months)
- Number of participants who discontinued study medication due to an AE(Up to 24 months)
- Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 12 months(Baseline and 12 months)
- Change from baseline in biochemical markers of bone turnover at 12 months(Baseline and 12 months)
- Percent responders (>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 12 months(12 months)
- Change from baseline in biochemical markers of bone turnover at 24 months(Baseline and 24 months)
- Percent responders ((>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 24 months(24 months)
- Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 24 months(Baseline and 24 months)