Estimation of Off-Label Use of XGEVA® (denosumab) Using Population-Based Databases in Denmark (20101335)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Evaluation of XGEVA off-label use
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  XGEVA
• Medical condition to be studied:
  Off label use

Population studied

• Short description of the study population:
  Patients with a treatment code for XGEVA in the Northern Jutland Region during the first 1-year period after the initial market availability of XGEVA.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  108

Study design details

• Main study objective:
  This study will evaluate off-label use of XGEVA® (denosumab) in Denmark during the first 1-year post XGEVA market availability, defined as 12 months after RADS opinion on 24th January 2013.
• Outcomes:
  On or off label individual prescription type.On or off label patient treatment. Type of off-label use.Off-label use stratified by administering department
• Data analysis plan:
  Primary statistical analysis will be based on data of off-label use after the initial market availability of XGEVA in Denmark. Stratified analysis will be done for data accumulated during the first year of commercial availability. Additional analyses will stratify 12-month periods into 6-month intervals. Study population will be characterized with regard to demographic factors, diagnoses and treatments using descriptive statistics. Categorical variables will be summarized in frequency tables and numeric variables as the number of observations, mean, standard deviation, quartiles, and median.

Documents

Study results

20101335 ORSR Abstract_FINAL