EDIROL Drug Intensive Monitoring: Post-Marketing Drug Intensive Monitoring Surveillance of EDIROL in Patients With Postmenopausal Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- the severity of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)
研究概览
简要总结
This is a post-marketing drug intensive monitoring surveillance with an observational, non-interventional design. The objectives are to compare the incidence of hypercalcemia in patients with and without calcium intake (including dietary supplements, excepting calcium from meals), and to monitor the type, incidence, severity, and relevance of other adverse drug reactions,including urolithiasis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal osteoporosis patients who signed the informed consent form and are expected to receive Edirol during the intensive monitoring period.
- •Patients with postmenopausal osteoporosis
- •Patients who signed the informed consent form
- •Patients who are expected to receive Edirol during planned enrollment period
排除标准
- •Exclude if any of the following:
- •No osteoporosis
- •Other osteoporosis (not postmenopausal)
- •Started Edirol before ICF signature
- •Did not sign ICF
结局指标
主要结局
the severity of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)
时间窗: through study completion, up to one year
the rates of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake
时间窗: one year from Edirol dosing date
the odds ratios of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake
时间窗: one year from Edirol dosing date
the proportion of each type of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)
时间窗: through study completion, up to one year
the incidence of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)
时间窗: through study completion, up to one year
次要结局
未报告次要终点