Denosumab Global Safety Assessment Among Women With Postmenopausal Osteoporosis (PMO), Men With Osteoporosis, and Men and Women Who Receive Prolia With Glucocorticoid Exposure in Multiple Observational Databases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 517,991
- 主要终点
- Describe denosumab utilization patterns
研究概览
简要总结
This is a prospective open-cohort study with annual assessment and reporting of descriptive findings from 5 secondary data sources, US Medicare, Optum Research Database (formerly United HealthCare), Scandinavian national health registry databases, including data from Denmark, Sweden, and Norway. The study period will include up to 10 years in each data system depending on data availability. Descriptive statistics will be used to characterize cohorts with respect to patient characteristics and utilization patterns. Person-year adjusted AESI incidence rates will be calculated among postmenopausal women, postmenopausal women with osteoporosis, and exposure cohorts with a final comparative safety analysis. Subsequent sub-studies using US data systems were added to describe men with osteoporosis treated with Prolia and men and women who receive Prolia with glucocorticoid exposure.
详细描述
This is a prospective open-cohort study with annual assessment and reporting of descriptive findings from 5 secondary data sources, US Medicare,Optum Research Database (formerly United HealthCare), Scandinavian national health registry databases, including data from Denmark, Sweden, and Norway. The study period will include up to 10 years in each data system depending on data availability. Descriptive statistics will be used to characterize exposure cohorts with respect to patient characteristics, clinical features, and AESI risk factors. Person-year adjusted AESI incidence rates will be calculated among postmenopausal women, postmenopausal women with osteoporosis, and exposure cohorts. Exploratory analyses comparing incidence rates of AESI in women with PMO adjusting for potential confounders will also be conducted. Descriptive statistics will be used to characterize denosumab utilisation patterns in patients who receive denosumab for PMO and in subjects who receive Prolia therapy for unapproved indications. Subsequent substudies using US data systems were added to describe men with osteoporosis treated with Prolia and men and women who receive Prolia with glucocorticoid exposure.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Women with post menopausal osteoporosis
Women with post menopausal osteoporosis
干预措施: denosumab (Drug)
Women with post menopausal osteoporosis
Women with post menopausal osteoporosis
干预措施: bisphosphonate (Drug)
Prolia for unapproved indications
Patients who receive Prolia for unapproved indications
干预措施: denosumab (Drug)
Men with osteoporosis
Men with osteoporosis treated with denosumab
干预措施: denosumab (Drug)
结局指标
主要结局
Describe denosumab utilization patterns
时间窗: Up to 10 years
Describe denosumab utilization patterns in patients who receive denosumab therapy for treatment of PMO.
Describe incidence rates of Adverse Events of Special Interest (AESI)
时间窗: Up to 10 years
Describe incidence rates of AESI in postmenopausal women.
Characteristics and Adverse Events of Special Interest (AESI) risk factors
时间窗: Up to 10 years
Describe characteristics, clinical features, and AESI risk factors in women with PMO exposed to denosumab, women with PMO exposed to bisphosphonates, and all women with PMO.
Describe Prolia utilization patterns
时间窗: Up to 10 years
Describe Prolia utilization patterns in patients who receive Prolia therapy for unapproved indications (indication, dosage, frequency).
Incidence rates of Adverse Events of Special Interest (AESI)
时间窗: Up to 10 years
Incidence rates of AESI (per 100,000 Person-years) will be assessed in postmenopausal women with osteoporosis (PMO) and by exposure cohort (denosumab or bisphosphonates)
Compare the incidence of the Adverse Events of Special Interests
时间窗: Up to 10 years
Compare the incidence of the AESI in women with PMO exposed to denosumab to that in women with PMO exposed to bisphosphonates.
次要结局
未报告次要终点