A Non-interventional Pharmacovigilance Study of Osteonecrosis of the Jaw and Infection Leading to Hospitalization Among Patients With Cancer Treated With
XGEVA™ or Zoledronic Acid in Sweden, Denmark, and Norway (20101363)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology
• 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:
  Osteonecrosis of jaw

  Pneumonia

  Skin infection

  Cellulitis

  Endocarditis

  Encephalitis

  Myelitis

  Encephalomyelitis

  Urinary tract infection

  Pyelonephritis

Population studied

• Short description of the study population:
  Eligibility criteria are: ≥ 18 years old, diagnosed with cancer, and, subsequent to cancer diagnosis, initiating antiresorptive treatment for SRE prevention during the treatment cohort identification period with XGEVA or zoledronic acid or switching to XGEVA from treatment for SRE prevention with oral or IV bisphosphonates of no more than 2 years duration (≤ 24 IV infusions or ≤ 24 monthly oral prescriptions).; The exclusion criteria are: radiation therapy to the head and neck region before a subject’s potential index date or having hypercalcemia of malignancy as the sole; indication for treatment with an anti-resorptive agent. Patients with a history of ONJ before the start of follow-up will be excluded when calculating incidence; proportions and incidence rates of ONJ.
• 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:
  Cancer patients
• Estimated number of subjects:
  3098

Study design details

• Main study objective:
  • Estimate, by treatment cohort, the yearly incidence proportions and 95% confidence intervals (CIs) for medically confirmed ONJ among patients with cancer whose initial antiresorptive treatment is XGEVA or IV zoledronic acid • Estimate, by treatment cohort, the yearly incidence proportions and 95% CIs for infection leading to hospitalization for XGEVA and zoledronic acid inception cohorts
• Outcomes:
  Medically confirmed osteonecrosis of the jaw (ONJ) and infection leading to hospitalization
• Data analysis plan:
  The 1-, 2-, 3-, 4-, and 5-year incidence proportions of medically confirmed ONJ in the three treatment cohorts were computed overall and stratified by primary cancer site, country, and calendar year of index date (2012, 2013, 2014). Patients who started follow-up in the zoledronic acid inception cohort and switched to XGEVA during the study period stopped contributing time to the zoledronic acid inception cohort and started contributing time to the XGEVA-switch cohort at the time of the switch. Binomial exact 95% CIs were computed for incidence proportions, and exact Poisson 95% CIs were computed for incidence rates.For infection leading to hospitalization, follow-up started on the cohort entry date. Only patients who had the opportunity to accrue full 1, 2, 3, 4, or 5 years after index date were included in the calculation of the respective incidence proportions. This restriction was not applied to incidence rate calculation.

Documents

Study results

Clinical Study Report 2020-01-07 20101363 ORSR Abstract