Survey of Oncology Practitioners Prescribing XGEVA® in Europe to Evaluate Their Knowledge of XGEVA® Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw (20110102)

Study type

• Study topic:
  Disease /health condition

  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Assess physicians knowledge of the SPC pertaining to risk or osteonecrosis of the jaw
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Physician survey

Study drug and medical condition

• Medical condition to be studied:
  Osteonecrosis of jaw

Population studied

• Short description of the study population:
  Oncology practitioners enrolled from the participating countries.
• Age groups:
  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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with osteonecrosis of jaw
• Estimated number of subjects:
  420

Study design details

• Main study objective:
  Proportion of participating oncology practitioners prescribing XGEVA® who are aware of the SPC statements pertaining to ONJ (each question pertaining to a SPC statement will be assessed seperately at the end of each survey round) Time Frame: 12 and 24 months after commercial availability of XGEVA® in the respective country
• Outcomes:
  Proportion of participating oncology practitioners prescribing XGEVA® who are aware of the SPC statements pertaining to ONJ (each question pertaining to a SPC statement will be assessed seperately at the end of each survey round) Time Frame: 12 and 24 months after commercial availability of XGEVA® in the respective country
• Data analysis plan:
  The study is descriptive in nature and does not test a formal hypothesis. The study endpoints represent the proportion of practitioners prescribing XGEVA® who are aware of SPC statements related to ONJ, measured using a standardized multiple-choice questionnaire. The no. of oncology practitioners eligible to participate, and the no. that agreed to participate in the survey will be captured. Results will be reported overall, and by each of 2 survey rounds corresponding to approx. month 12 and month 24 after commercial availability of XGEVA in the respective countries. Questions not answered will be considered as incorrect answers and included in the denominators. Standard errors will be calculated based on the normal approximation to the binomial distribution. Two-sided 95% confidence intervals will be estimated as the proportion ± 1.96 multiplied by the standard error. Results will be stratified by 2 regions: Nordic countries vs. the 5 largest European countries by population size.

Documents

Study results

20110102 ORSR Abstract_10SEP2015