NCT01967160CompletedNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 2,560
- Primary Endpoint
- 2. Incidence proportions of infections leading to hospitalization in XGEVA and zoledronic acid inception cohorts
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 18 years old
- •diagnosed with cancer
- •subsequent to cancer diagnosis, initiating cancer-related antiresorptive treatment during the treatment cohort identification period with XGEVA or zoledronic acid or switching to XGEVA from cancer-related treatment with oral or IV bisphosphonates at the dose indicated for SRE prevention of less than 2 years duration (≤ 24 IV infusions or ≤ 24 monthly oral prescriptions)
Exclusion Criteria
- •history of radiation treatment for head and neck cancer before a subject's potential index date
- •hypercalcemia of malignancy as the sole indication for treatment with an anti-resorptive agent
Outcomes
Primary Outcomes
2. Incidence proportions of infections leading to hospitalization in XGEVA and zoledronic acid inception cohorts
Time Frame: 3 years
1. Incidence proportions of medically confirmed osteonecrosis of the jaw (ONJ) in XGEVA and zoledronic acid inception cohorts
Time Frame: 5 years
Secondary Outcomes
- 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(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(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(5 years)
- 4. Summarize oral risk factor information for medically confirmed ONJ cases(5 years)
- 5. Summarize for medically confirmed ONJ cases information on ONJ stage, treatment, clinical course, and resolution(5 years)
Investigators
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