NCT00541658已完成3 期
A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 923
- 试验地点
- 2
- 主要终点
- Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population
研究概览
简要总结
The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
详细描述
The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given 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
- Triple (Participant, Care Provider, 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
- •Female: 50 years of age or older
- •>5 years since last menses natural or surgical
- •have lumbar spine or total hip BMD more that 2.5 SD below the young adult mean, or have lumbar spine or total hip BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture
排除标准
- •history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
- •BMI >32 kg/m
- •use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
- •hypocalcemia or hypercalcemia of any cause
- •markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator
研究组 & 干预措施
5 mg Before Breakfast
Active Comparator
5 mg / Immediate-release Risedronate (At Least 30 Minutes Before Breakfast)
干预措施: risedronate (Drug)
35 mg After Breakfast
Experimental
35 mg / Delayed-release Risedronate (Immediately Following Breakfast)
干预措施: risedronate (Drug)
35 mg Before Breakfast
Experimental
35 mg / Delayed-release Risedronate (At Least 30 Minutes Before Breakfast)
干预措施: risedronate (Drug)
结局指标
主要结局
Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population
时间窗: 52 weeks / Endpoint
次要结局
- Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population(Week 52 / Endpoint)
- Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population(Week 26)
- Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population(Week 52)
- Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population(Week 104)
- Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population(Week 104 / Endpoint)
- Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population(Week 52)
- Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population(Week 52 / Endpoint)
- Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population(Week 52)
- Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population(Week 52 / Endpoint)
- Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population(Week 26)
- Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population(Week 52)
- Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population(Week 52 / Endpoint)
- Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population(Week 104)
- Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population(Week 104 / Endpoint)
- Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population(Week 26)
- Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population(Week 52)
- Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population(Week 52 / Endpoint)
- Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population(Week 104)
- Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population(Week 104 / Endpoint)
- Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population(Week 26)
- Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population(Week 52)
- Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint(Week 52 / Endpoint)
- Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population(Week 104)
- Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint(Week 104 / Endpoint)
- Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population(Week 13)
- Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population(Week 26)
- Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population(Week 52)
- Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population(Week 52 / Endpoint)
- Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population(Week 104)
- Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population(Week 104 / Endpoint)
- Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population(Week 13)
- Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population(Week 26)
- Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population(Week 52)
- Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population(Week 52 / Endpoint)
- Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population(Week 104)
- Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population(Week 104 / Endpoint)
- Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population(Week 13)
- Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population(Week 26)
- Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population(Week 52)
- Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population(Week 52 / Endpoint)
- Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population(Week 104)
- Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population(Week 104 / Endpoint)
- Number of Patients With at Least One New Fractured Vertebra, Week 52(Week 52)
- Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population(Week 52 / Endpoint)
- Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population(Week 104)
- Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population(Week 104 / Endpoint)
- Number of Patients With No New Fractured Vertebra, Week 52(Week 52)
- Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint(Week 52 / Endpoint)
- Number of Patients With No New Fractured Vertebra, Week 104(Week 104)
- Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint(Week 104 / Endpoint)
研究者
研究点 (2)
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