CTRI/2011/091/000046已完成4 期
An observational, prospective, open-label study to assess effectiveness, safety and tolerability of once-yearly treatment with zoledronic acid in osteoporotic patients in a real-world setting - AZURE
ovartis Healthcare Pvt Ltd0 个研究点目标入组 3,400 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Post menopausal osteoporosis: Female post menopausal osteoporotic patients who have been prescribed once yearly therapy with 5 mg i.v. zoledronic acid in adherence with the local prescribing information.
- •2. Glucocorticoid-induced osteoporosis :Male or female osteoporotic patients aged ≥18 years, receiving at least 5 mg/d oral prednisone (or equivalent systemic steroid) at study entry, and expected to receive glucocorticoids for at least another 12 to 24 months, who have been prescribed once yearly therapy with 5 mg i.v. zoledronic acid in adherence to the local prescribing information
- •3. Male Osteoporosis indication: Male patients aged ≥ 50 years, diagnosed with male osteoporosis, who have been prescribed once yearly therapy with 5 mg i.v. zoledronic acid in adherence with the local prescribing information
- •4. Patients for whom the treating physician recommends treatment with once yearly therapy with 5 mg i.v. zoledronic acid, and zoledronic acid has been prescribed in the course of routine medical practice and according to local Summary of Product Characteristics (SmPC) or Prescribing Information (PI)
- •5. Patients willing to answer short questionnaires (back pain and disability, patient satisfaction and patient preference for treatment questionnaires)
- •6. Patients willing to be followed for up to 24 months
- •7. Patients who consent to have their data collected. Patients will not need to consent to taking the drug, as their treatment is decided before entry into the study and is part of their medical care
排除标准
- •1.Any contraindication according to local SmPC or PI (Summary of Product Characteristics or Prescribing Information) of 5 mg i.v. zoledronic acid including pregnant and nursing women
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