Osteonecrosis of the Jaw (ONJ) and Infection Among Nordic Cancer Patients Treated With XGEVA™ or Zoledronic Acid

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01967160

Enrollment

2560

Registered

2013-10-22

Start date

2012-01-02

Completion date

2019-08-05

Last updated

2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection Leading to Hospitalization, Osteonecrosis of the Jaw

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
1. Incidence proportions of medically confirmed osteonecrosis of the jaw (ONJ) in XGEVA and zoledronic acid inception cohorts	5 years
2. Incidence proportions of infections leading to hospitalization in XGEVA and zoledronic acid inception cohorts	3 years

Secondary

Measure	Time frame
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
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
5. Summarize for medically confirmed ONJ cases information on ONJ stage, treatment, clinical course, and resolution	5 years
4. Summarize oral risk factor information for medically confirmed ONJ cases	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

Outcome results