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Study Complete
Sponsor ID
20101335

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

Sponsor ID
20101335
Clinicaltrials.gov ID
NCT02066805
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
N/A
Product
denosumab
Type
Observational
Masking
N/A
Enrollment
142
Additional Study Details

Protocol Summary

Primary Outcome Measures

on or off label individual prescription type

Timeframe: 12 months

on or off label patient treatment

Timeframe: 12 months

Secondary Outcome Measures

type of off-label use

Timeframe: 12 months

off-label use stratified by administering department

Timeframe: 12 months

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
N/A
Condition
  • XGEVA Off-Label Registry
    • Sex
    N/A
    Trial Dates
    Jan 2014 - Feb 2015
    Inclusion and Exclusion 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