Double-blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 719
- 主要终点
- Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD
研究概览
简要总结
This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. 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 (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •successful completion of Bonviva study BM16549, with at least 75% compliance;
- •ambulatory.
排除标准
- •malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);
- •breast cancer diagnosed within the previous 22 years.
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
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD
时间窗: Baseline and Months 12, 24 and 36
Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm\^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).
Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)
时间窗: Baseline and Months 12, 24 and 36
BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae \[L2-L4\] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).
次要结局
- Absolute Change From Baseline in Mean Total Hip BMD(Baseline and 12, 24 and 36 months)
- Relative Percent Change From Baseline in Mean Total Hip BMD(Baseline, 12, 24 and 36 months)
- Relative Percent Change From Baseline of Trough Serum CTX(Baseline, 6,12, 24 and 36 months)
- Absolute Change From Baseline of Trough Serum CTX(Baseline, 6, 12, 24 and 36 months)