Prospective Observational Study to Evaluate Medication-taking Behavior With Denosumab (Prolia) and Patient Characteristics in Postmenopausal Women With Osteoporosis in Routine Clinical Practice in Germany, Austria, Greece and Belgium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 1,501
- 试验地点
- 1
- 主要终点
- Percentage of Participants Adherent to Denosumab Injection at 12 Months and 24 Months
研究概览
简要总结
The main objective of this observational study was to describe medication-taking behavior of patients treated with denosumab for postmenopausal osteoporosis (PMO) at 12 and 24 months.
详细描述
The decision to treat patients with denosumab was made independent of and before their enrolment in the study. No study drug was administered as part of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Indicated for treatment of osteoporosis in postmenopausal women at increased risk of fractures according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).
- •Enrolled into the study within 4 weeks of receiving their first injection of Prolia® according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).
- •Appropriate written informed consent has been obtained (as required per local country regulations).
排除标准
- •Patient is currently enrolled in or has been enrolled within the prior 6 months in a study involving any investigational procedure, device or drug.
- •Contraindicated for treatment with Prolia® according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).
- •Participation in ongoing or previous denosumab clinical trials.
- •Patient has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the patient to give written informed consent.
结局指标
主要结局
Percentage of Participants Adherent to Denosumab Injection at 12 Months and 24 Months
时间窗: 12 months and 24 months
A participant was considered adherent to denosumab at 12 months if they received at least 1 denosumab injection over the 12-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart). A participant was considered adherent to denosumab at 24 months if they received at least 3 denosumab injections over the 24-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart).
Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months
时间窗: 12 months and 24 months
A participant was considered persistent with denosumab at 12 months if they received at least 1 denosumab injection following the pre-enrolment denosumab injection no later than 6 months + 8 weeks (ie, no greater than 239 days apart). A participant was considered persistent with denosumab at 24 months if they received at least 3 denosumab injections following the pre-enrolment denosumab injection, and the length of time between any 2 consecutive denosumab injections did not exceed 6 months + 8 weeks (ie, no greater than 239 days apart).
Medication Coverage Ratio (MCR) for Denosumab Injection at 12 Months and 24 Months
时间窗: From baseline to 12 months and 24 months
MCR at 12 months was defined as the accumulative number of days covered with denosumab treatment during the first 12 months divided by 366 days, expressed as a percentage. MCR at 24 months was defined as the accumulative number of days covered with denosumab treatment during the first 24 months divided by 732 days, expressed as a percentage. It was assumed that each injection of denosumab treatment provided 6 months of coverage (or 183 days) from the date of injection or until the date of the next injection, whichever comes first. So, a participant who received only 1 injection in the first year would have MCR at 12 months equal to 50%.
次要结局
- Percentage of Participants Who Received Denosumab Injections Within the Specified Window(24 months)
- Time to Non-persistence With Denosumab Injection(24 months)
- Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at 24 Months(Baseline and Month 24)
- Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 24 Months(Baseline and Month 24)
- Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 24 Months(Baseline and Month 24)