A Two Year Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Fracture Efficacy and Safety of Intravenous Zoledronic Acid 5 mg Annually for the Treatment of Osteoporosis in Men
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,199
- 试验地点
- 3
- 主要终点
- Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months
研究概览
简要总结
This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Osteoporosis as defined by very low bone mineral density in the hip and spine or low bone mineral density in the hip combined with presence of 1-3 mild or moderate fractures of the vertebrae
排除标准
- •Low Vitamin D
- •Renal insufficiency
- •Previous treatment with certain anti-osteoporotic therapies (except after certain washout periods): calcitonin, bisphosphonates, parathyroid hormone (PTH), sodium fluoride, strontium ranelate,
- •Previous treatment with testosterone, anabolic steroids or growth hormone
- •Chronic use of systemic corticosteroids (oral or i.v.) within the last year
- •History of any cancer or metastases within the last 5 years
- •History of brittle bone disease, multiple myeloma, or Paget's disease, or any other metabolic bone disease, except osteoporosis
- •Bilateral hip replacements
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Zoledronic Acid
5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
干预措施: Zoledronic acid 5 mg iv (Drug)
Placebo
100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months
时间窗: 24 Months
Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height
次要结局
- Number of Participants With First Clinical Fracture(24 months)
- Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months(Baseline, Month 24)
- Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months(12 Months)
- Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months(12 months)
- Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months(24 Months)
- Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months(Baseline, 12 months)
- Mean Change in Height From Baseline(from Baseline to 12 months and 24 months)
- Number of Participants With First Clinical Vertebral Fracture(24 months)
- Serum Beta C-terminal Telopeptides of Type I Collagen(b-CTx) by Visits(Baseline, Month 3, Month 6, Month 12, Month 15, month 18, Month 24)
- Number of Participants With First Non-vertebral Fracture(24 months)
- Percentage Change From Baseline in Lumbar Spine Bone Mass Density (BMD)(Month 6, Month 12, Month 24)
- Percentage Change From Baseline in Total Hip BMD (g/CM^2)(Month 6, Month 12, Month 24)
- Percentage Change From Baseline in Femoral Neck BMD (g/CM^2)(Month 6, Month 12, Month 24)