A Randomized, Double-blind Study Comparing the Effect of Different Treatment Regimens of Intravenous Bonviva on Lumbar Bone Mineral Density in Women With Osteoporosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,395
- 主要终点
- Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months
研究概览
简要总结
This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.
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
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women 55-80 years of age;
- •post-menopausal for >=5 years;
- •ambulatory.
排除标准
- •malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
- •breast cancer within the previous 20 years;
- •allergy to bisphosphonates;
- •previous treatment with an intravenous bisphosphonate at any time;
- •previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, or >3 months of treatment within the last 2 years.
研究组 & 干预措施
1
oral placebo daily and IV ibandronate 2 mg q 2 mo
干预措施: ibandronate [Bonviva/Boniva] (Drug)
2
oral ibandronate 2.5 mg daily and IV placebo q 2 mo and q 3 mo
干预措施: ibandronate [Bonviva/Boniva] (Drug)
3
oral placebo daily and IV ibandronate 3 mg q 3 mo
干预措施: ibandronate [Bonviva/Boniva] (Drug)
结局指标
主要结局
Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months
时间窗: Baseline and Month 12
BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 12. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)
次要结局
- Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24(Baseline, Month 12 and Month 24)
- Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months(Baseline and Month 24)
- Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24(Baseline, Month 12 and Month 24)
- Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24(Baseline, Month 12 and Month 24)
- Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24(At Month 12 and 24)
- Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24(Baseline, At Month 6, 12, and 24.)
- Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24(Baseline, At Month 6, 12, and 24.)
- Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24(At Month 12 and 24)
- Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24(At Month 12 and 24)
- Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24(At Month 12 and 24)
- Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24(At Month 12 and 24)
- Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24(At Month 12 and 24)
- Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24(At Month 12 and 24)
- Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs)(Approximately 2 years)
- Number of Participants With Any Marked Abnormality in Laboratory Parameters(Approximately 2 years)