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

Amgen0 sites2,560 target enrollmentJanuary 2, 2012

ConditionsOsteonecrosis of the Jaw Infection Leading to Hospitalization

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteonecrosis of the Jaw
Sponsor: Amgen
Enrollment: 2560
Primary Endpoint: 2. Incidence proportions of infections leading to hospitalization in XGEVA and zoledronic acid inception cohorts
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

January 2, 2012

End Date

August 5, 2019

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

Eligibility Criteria

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)