Double-blind, Placebo-controlled, Randomized, Multicenter Study to Assess the Efficacy and Safety of Oral Ibandronate Once Monthly in Postmenopausal Women With Osteopenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 主要终点
- Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12
研究概览
简要总结
This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 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
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women 45-60 years of age;
- •post-menopausal;
- •ambulatory.
排除标准
- •vertebral fracture (except traumatic fracture such as in a motor vehicle accident);
- •low-trauma osteoporotic fracture in any other bone;
- •breast cancer diagnosed within last 20 years;
- •other malignancy diagnosed within last 10 years, except successfully resected basal cell cancer;
- •treatment with any bisphosphonate within last 2 years;
- •treatment with other drugs affecting bone metabolism within last 6 months.
研究组 & 干预措施
1
干预措施: ibandronate [Bonviva/Boniva] (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12
时间窗: Baseline and Month 12
BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. 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 the Proximal Femur at Month 12(Baseline and Month 12)
- Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX)(Baseline and 3, 6 and 12 months)
- Absolute Change From Baseline in sCTX(Baseline and 3, 6, 12 months)
- Percentage of Responders(Up to 12 months)
- Relative Change From Baseline in Mean Proximal Femur BMD at Month 12(Baseline and Month 12)
- Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 15 days after end of study treatment (Approximately 2 years))
- Number of Participants With Marked Laboratory Abnormalities(Screening up to 12 months)
- Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12(Baseline and Month 12)