Estimation of Off-Label Use of XGEVA� (Denosumab) Using Population-Based Databases in Denmark
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: XGEVA Off-label Use
Intervention: Database assessment of off-label XGEVA use (Drug)
Phase: N/A
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
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.
Clinical Details
Official title: Estimation of Off-Label Use of XGEVA® (Denosumab) Using Population-Based Databases in Denmark
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: on or off label individual prescription typeon or off label patient treatment
Secondary outcome: type of off-label useoff-label use stratified by administering department
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
AmgenTrials clinical trials website
Starting date: January 2014
Last updated: May 27, 2015
|