Study Complete
Sponsor ID
20101363
Osteonecrosis of the Jaw (ONJ) and Infection among Nordic Cancer Patients Treated with XGEVA™ or Zoledronic Acid
Study Details
A non-interventional study to assess incident rates of Osteonecrosis of the Jaw and Infections leading to hospitalization in Cancer patients treated with XGEVA™ in Sweden, Denmark and Norway.
Protocol Summary
Primary Outcome Measures
1. Incidence proportions of medically confirmed osteonecrosis of the jaw (ONJ) in XGEVA and zoledronic acid inception cohorts
Timeframe: 5 years
2. Incidence proportions of infections leading to hospitalization in XGEVA and zoledronic acid inception cohorts
Timeframe: 3 years
Secondary Outcome Measures
1. Incidence proportions of medically confirmed ONJ in the cohort switching from an oral or IV bisphosphonate (at the dose indicated for cancer patients to prevent skeletal related events) to XGEVA
Timeframe: 5 years
2. Incidence proportions of medically confirmed ONJ in the cohort switching from an oral or IV bisphosphonate (at the dose indicated for cancer patients to prevent SREs) to XGEVA stratified by number of prior cancer-related bisphosphonate treatments
Timeframe: 5 years
3. Characterize the XGEVA inception, zoledronic acid inception, and the XGEVA-switch cohorts with respect to patient characteristics, cancer type, medical history, and number of bisphosphonate or XGEVA treatments at the dose indicated for SRE prevention
Timeframe: 5 years
4. Summarize oral risk factor information for medically confirmed ONJ cases
Timeframe: 5 years
5. Summarize for medically confirmed ONJ cases information on ONJ stage, treatment, clinical course, and resolution
Timeframe: 5 years
Locations
No locations found.