Open Label, Parallel Group, Multicenter Study of Two Intravenous (IV) Ibandronate Dose Regimens (2 mg Every 2 Months and 3 mg Every 3 Months) in Women With Postmenopausal Osteoporosis Who Completed Trial BM16550
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 781
- 主要终点
- Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months
研究概览
简要总结
This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75% compliance
- •Ambulatory
排除标准
- •Patients who completed the Bonviva study BM16550 (NCT00048074) >3 months before the planned start date for this study
- •Malignant disease diagnosed since inclusion into previous study
- •Treatment with drugs affecting bone metabolism since inclusion into previous study
研究组 & 干预措施
1
干预措施: ibandronate [Bonviva/Boniva] (Drug)
2
干预措施: ibandronate [Bonviva/Boniva] (Drug)
结局指标
主要结局
Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months
时间窗: Baseline,12, 24 and 36 months
Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=\[(measure at time t - measure at baseline)/measure at baseline\]\*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.
次要结局
- Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months(Baseline,12, 24 and 36 months)
- Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months(Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550))
- Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months(Baseline, 6 months)