Interventional, Single Arm, Open Label Study of the Efficacy, Safety and Compliance to the Treatment With Intravenous (IV) Ibandronate (Bonviva®) in the Postmenopausal Osteoporosis Treatment of Bisphosphonates naïve Patients in Daily Practice
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
研究概览
简要总结
This single arm, open label study will assess the efficacy and safety of and compliance to treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg intravenously every three months. Anticipated time on study treatment is 12 months with a follow-up of 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients, > 50 years of age
- •Diagnosed osteoporosis
- •Bone mineral density < minus 2.5 SD or osteoporotic fracture
- •At least 3 years after menopause
排除标准
- •Impaired renal function
- •Contra-indication to Calcium or Vitamin D therapy
- •Previous or current treatment with biphosphonates
研究组 & 干预措施
Single Arm
干预措施: ibandronate [Bonviva/Boniva] (Drug)
结局指标
主要结局
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
时间窗: Baseline, Month 12
Percent change was calculated as \[(measure at time "t" minus \[-\] measure at baseline) divided by (/) measure at baseline\] multiplied by (\*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.
Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24
时间窗: Baseline, Month 24
Percent change was calculated as \[(measure at time "t" - measure at baseline)/measure at baseline\]\*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.
Percent Change From Baseline in Mean Hip Bone BMD at Month 12
时间窗: Baseline, Month 12
Percent change was calculated as \[(measure at time "t" - measure at baseline)/measure at baseline\]\*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.
Percent Change From Baseline in Mean Hip BMD at Month 24
时间窗: Baseline, Month 24
Percent change was calculated as \[(measure at time "t" - measure at baseline)/measure at baseline\]\*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.
次要结局
- Correlation Coefficient of Participant's Profile With Compliance(Baseline up to Month 12)
- Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24(Baseline, Month 12, Month 24)
- Percentage of Participants Who Received All Planned Study Medication (Compliance)(Baseline up to Month 12)
- Percent Change From Baseline in Total Hip T-score at Month 12 and 24(Baseline, Month 12, Month 24)