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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Collaborator: University of Aarhus
• Treatments: Denosumab

Criteria

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:

n/a