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

N/ACompletedNCT02066805

Amgen142 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

142

Conditions

XGEVA Off-label Use

Interventions

Database assessment of off-label XGEVA useDRUG

No intervention is planned during this study as it involves analyses of patient electronic records from Northern Jutland Region and Copenhagen

Eligibility

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

on or off label individual prescription type

Yes/no regarding whether an individual prescription was on (or off) label

Time frame: 12 months

on or off label patient treatment

Yes/no regarding whether the patient was treated on (or off) label

Time frame: 12 months

Secondary Outcomes

type of off-label use

XGEVA prescription for each type of off-label use

Time frame: 12 months

off-label use stratified by administering department

Prescriptions that are for off-label use stratified by department that administers treatment

Time frame: 12 months

Data from ClinicalTrials.gov

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