Estimation of Off-Label Use of XGEVA® (Denosumab) Using Population-Based Databases in Denmark
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 142
- Primary Endpoint
- on or off label individual prescription type
Study Overview
Brief Summary
This study aims to evaluate off-label XGEVA use in Denmark using data linked from registries and other sources in Northern Jutland Region and Copenhagen. This will allow for accurate assessment of prescriptions and diagnoses, especially those related to cancer patients during the first year post the initial market availability of XGEVA.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The study will include patients with a prescription for XGEVA® given in secondary care with a minimum of 108 XGEVA users, in the Northern Jutland Region and Copenhagen during the first 1-year post XGEVA market availability, defined as 12 months after RADS opinion on 24th January 2013 or after the minimum sample has been achieved.
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort 1
Intervention: Database assessment of off-label XGEVA use (Drug)
Outcomes
Primary Outcomes
on or off label individual prescription type
Time Frame: 12 months
Yes/no regarding whether an individual prescription was on (or off) label
on or off label patient treatment
Time Frame: 12 months
Yes/no regarding whether the patient was treated on (or off) label
Secondary Outcomes
- type of off-label use(12 months)
- off-label use stratified by administering department(12 months)
