A 1-year, Risedronate-free, Multicenter, Outpatient, Phase IIIb Extension Study to Assess Bone Turnover Recovery in Women With Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, and RVE1998080 (no NCT Study Numbers)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population
研究概览
简要总结
The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized.
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
- None
入排标准
- 年龄范围
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women who sequentially completed studies RVE009093, RVE1996077, RVE1998080
排除标准
- •Less than 60% compliant between drug start and month 21
- •Using bisphosphonates, glucocorticoids, anabolic steroids, vitamin D supplements, calcitrol, estrogen or estrogen-related drugs, progestogen, depot injection >10,000 IU vitamin D, investigational drug
研究组 & 干预措施
Placebo/Risedronate
Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
干预措施: Placebo/Risedronate (Drug)
Risedronate
Risedronate 5mg years 1-7, no drug year 8
干预措施: Risedronate (Drug)
结局指标
主要结局
Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population
时间窗: Baseline Core Study (Year 1) to Month 6 (Year 8)
Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2\*BMD, Hologic sBMD = 1075.5\*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population
时间窗: Baseline Core Study (Year 1) to Month 12 (Year 8)
Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2\*BMD, Hologic sBMD = 1075.5\*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
时间窗: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Endpoint is the last measurement during the 12 month treatment period during Year 8. Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2\*BMD, Hologic sBMD = 1075.5\*BMD. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population
时间窗: Baseline Core Study (Year 1) to Month 6 (Year 8)
Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836\*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population
时间窗: Baseline Core Study (Year 1) to Month 12 (Year 8)
Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836\*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
时间窗: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Endpoint is the last measurement during the treatment period (thru Month 12, Year 8). Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836\*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population
时间窗: Baseline Core Study (Year 1) to Month 6 (Year 8)
Month 6, Year 8 compared to Baseline, Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population
时间窗: Baseline Core Study (Year 1) to Month 12 (Year 8)
Baseline, year 1 compared with Month 12, year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
时间窗: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Endpoint is the last measurement during the treatment period (through Month 12, Year 8) compared with baseline Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population
时间窗: Baseline Core Study (Year 1) to Month 6 (Year 8)
Baseline, Year 1 compared with Month 6, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population
时间窗: Baseline Core Study (Year 1) to Month 12 (Year 8)
Baseline, Year 1 compared with Month 12, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
时间窗: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Baseline, Year 1 compared with Endpoint (last measurement during the treatment period through Month 12), Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).
次要结局
未报告次要终点