NCT00619957已完成3 期
Two-year Study to Determine the Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis for 2 Years Followed by a 2 Year Open Label Study
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
- 285
- 试验地点
- 2
- 主要终点
- Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.
研究概览
简要总结
Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Documented osteoporosis of the femoral neck and lumbar spine
排除标准
- •BMI greater than or equal to 35
研究组 & 干预措施
1
Placebo Comparator
Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years
干预措施: Placebo tablet (Drug)
Risedronate
Experimental
35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years
干预措施: Risedronate (Drug)
结局指标
主要结局
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.
时间窗: Baseline to 24 Months/Endpoint
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
次要结局
- Percent Change From Baseline in CTx, Month 24, ITT Population.(Baseline to Month 24)
- Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.(Baseline to Month 12)
- Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.(Baseline to Month 6)
- Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.(Baseline to Month 12)
- Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.(Baseline to Month 24)
- Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.(Baseline to 24 Months/Endpoint)
- Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.(Baseline to Month 3)
- Percent Change From Baseline in CTx, Month 6, ITT Population.(Baseline to Month 6)
- Percent Change From Baseline in CTx, Month 12, ITT Population.(Baseline to Month 12)
- Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.(Baseline to Month 3)
- Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.(Baseline to 24 Months/Endpoint)
- Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.(Baseline to Month 6)
- Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.(Baseline to Month 12)
- Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.(Baseline to Month 24)
- Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.(Baseline to 24 Months/Endpoint)
- Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.(Baseline to Month 3)
- Percent Change From Baseline in BAP, Month 6, ITT Population.(Baseline to Month 6)
- Percent Change From Baseline in BAP, Month 12, ITT Population.(Baseline to Month 12)
- Percent Change From Baseline in BAP, Month 24, ITT Population.(Baseline to Month 24)
- Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.(Baseline to 24 Months/Endpoint)
- Change From Baseline in Body Height, Month 12, ITT Population.(Baseline to Month 12)
- Change From Baseline in Body Height, Month 24, ITT Population.(Baseline to Month 24)
- Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.(Baseline to 24 Months/Endpoint)
- Percent of Responders Lumbar Spine BMD, Month 24, ITT Population(Baseline to Month 24)
- Cumulative Incidence of Fractures, 12 Months, ITT Population(Baseline to Month 12)
- Cumulative Incidence of Fractures, 24 Months, ITT Population(Baseline to Month 24)
- Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.(Baseline to Month 6)
- Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.(Baseline to Month 24)
- Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.(Baseline to Month 24)
- Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.(Baseline to 24 Months/Endpoint)
- Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.(Baseline to Month 6)
- Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.(Baseline to Month 12)
- Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.(Baseline to Month 6)
- Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.(Baseline to Month 12)
- Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.(Baseline to Month 24)
- Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.(Baseline to 24 Months/Endpoint)
研究者
研究点 (2)
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