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Clinical Trials/NCT02066805
NCT02066805CompletedNot Applicable

Estimation of Off-Label Use of XGEVA® (Denosumab) Using Population-Based Databases in Denmark

Amgen0 sites142 target enrollmentStarted: January 2014Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Amgen
Enrollment
142
Primary Endpoint
on or off label individual prescription type
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

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)

Investigators

Sponsor
Amgen
Sponsor Class
Industry
Responsible Party
Sponsor

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