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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 type

on or off label patient treatment

Secondary outcome:

type of off-label use

off-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

Page last updated: August 23, 2015

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