A 2-year Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of Intravenous Zoledronic Acid 5 mg Administered Either Annually at Randomization and 12 Months, or Administered at Randomization Only in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 581
- 试验地点
- 1
- 主要终点
- Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum
研究概览
简要总结
Osteoporosis prevention is important in patients with osteopenia (low bone density). This study will test the safety and efficacy of zoledronic acid in patients diagnosed with osteopenia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal
- •Greater than or equal to 45 years of age
- •Osteopenia (lumbar spine bone mineral density [BMD] T-score between -1.0 and -2.5, and BMD T-score > -2.5 at the femoral neck)
排除标准
- •Patients with more than one Grade 1 vertebral fracture (as per Genant method; patients with one Grade 1 vertebral fracture are eligible to participate)
- •Patients with any Grade 2 or 3 vertebral fracture (as per Genant method)
- •Patients with 25-(OH) vitamin D levels less than 15 ng/mL prior to randomization
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Zoledronic Acid 2x5 mg
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
干预措施: Zoledronic Acid (Drug)
Zoledronic Acid 1x5 mg
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12
干预措施: Zoledronic Acid (Drug)
Zoledronic Acid 1x5 mg
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12
干预措施: Placebo (Drug)
Placebo
Placebo given at randomization and Month 12
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum
时间窗: Baseline, Month 24
The percentage change in lumbar spine BMD at Month 24 relative to baseline was derived as 100 x (lumbar spine BMD at 24 Month - lumbar spine BMD at baseline) / (lumbar spine BMD at baseline).
次要结局
- Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum.(Baseline, Month 24)
- Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum.(Baseline, Month 24)
- Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum(Months 6, 12, 18 and 24)
- Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum(Months 6, 12, 18 and 24)
- Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum(Months 6, 12, 18 and 24)