NCT00984893已完成不适用
A Real-world Study Cohort of Postmenopausal Women With Osteoporosis Taking Zoledronic Acid or Oral Bisphosphonates
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,551
- 试验地点
- 1
- 主要终点
- Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA)
研究概览
简要总结
The study will assess the real life effectiveness of zoledronic acid in the management of patients with osteoporosis over 4 years of treatment. Zoledronic acid will be compared to oral bisphosphonates (OBP) with respect to the change in Bone Mineral Density (BMD) and incidence of fractures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient is an ambulatory female 45 years of age or older
- •Postmenopausal women with diagnosis of osteoporosis
- •Prescription of zoledronic acid or any OBP as per the current Canadian monograph
- •Must provide informed consent
排除标准
- •Any prior use of iv bisphosphonates within the last 2 years
- •Known secondary osteoporosis of any aetiology (hypogonadism in premenopausal women or premature menopause, malabsorption, chronic liver disease, inflammatory bowel disease)
- •Metabolic bone diseases such as primary or secondary hyperparathyroidism, hypoparathyroidism, Paget's disease of bone, Fibrous dysplasia..
- •Non-corrected hypocalcaemia at the time of zoledronic acid infusion
- •Creatinine clearance < or = 30 ml/min
- •Unwillingness or inability to comply with the study requirements
- •Concurrent participation in a clinical trial of an investigational drug, or within the last 30 days
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Zoledronic acid
干预措施: zoledronic acid (Drug)
Oral Bisphosphonates
干预措施: Any oral bisphosphonates marketed in Canada (Drug)
结局指标
主要结局
Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA)
时间窗: 4 years
次要结局
- change in femoral neck BMD as measured by dual energy x-ray absorptiometry (DXA)(4 years)
- change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)(4 years)
- Percent change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)(4 years)
- Risk for fractures(4 years)
- Burden of illness, health care resource utilization, and loss of productivity(4 years)
研究者
研究点 (1)
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