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
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 3,400
- 主要终点
- 1. To assess treatment adherence to once yearly therapy with 5 mg i.v. zoledronic acid under real-world clinical practice conditions over observational periods of 12 months and 24 months (based on consecutive yearly injections)
研究概览
简要总结
Osteoporosis is associated with significant morbidity and mortality, which place a heavy burden on society. The efficacy of current osteoporosis therapies is compromised by low rates of adherence and persistence. Poor adherence is associated with significant clinical consequences, most notably, increased fracture rates. Annual infusions of an osteoporosis drug may be one means of improving adherence and persistence. Indeed, a patient preference study of theoretical treatment choices found that 65% of treatment-naïve patients said they would prefer an annual bisphosphonate (BP) infusion to weekly pills. Limited patient numbers determined by stringent inclusion and exclusion criteria of RCTs preclude application of the findings to a larger population. Observational studies are needed to examine the effectiveness, safety and tolerability of the treatment in routine clinical practice, to determine how the treatment works under ordinary and variable conditions, prescribed by clinicians with varying degrees of expertise and practicing across the spectrum of health care settings, to treat a heterogeneous group of patients. The AZURE study (Assessment of Zoledronic acid Utilizing Real-world Experience) is 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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
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.
- •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
- •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
- •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)
- •Patients willing to answer short questionnaires (back pain and disability, patient satisfaction and patient preference for treatment questionnaires)
- •Patients willing to be followed for up to 24 months
- •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.
结局指标
主要结局
1. To assess treatment adherence to once yearly therapy with 5 mg i.v. zoledronic acid under real-world clinical practice conditions over observational periods of 12 months and 24 months (based on consecutive yearly injections)
时间窗: At 12 months and 24 months
次要结局
- 1. To study the evolution of bone mineral density over observational periods of 12 months and 24 months in patients receiving once yearly therapy with 5 mg i.v. zoledronic acid under real-world clinical practice conditions.2. To characterize the patient population (demographics, medical histories, osteoporosis risk factors, prior and co-medications etc.) receiving once yearly therapy with 5 mg i.v. zoledronic acid under real-world clinical practice conditions3. To evaluate the safety of once yearly therapy with 5 mg i.v. zoledronic acid under real-world clinical practice conditions over an observational period of 24 months 4. To evaluate the patient preference for treatment5. To study other indicators of bone health (back pain, fragility fractures) over an observational periods of 12 months and 24 months in patients receiving once yearly therapy with 5 mg i.v. zoledronic acid under real-world clinical practice(At 12 months and 24 months)