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

Completed

• Conditions: Osteonecrosis of the Jaw; Infection Leading to Hospitalization

• Registration Number: NCT01967160
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-02
• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-22
• Primary Completion: 2019-08-05
• Study Completion: 2019-08-05
• Status Verified: 2021-09
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2560

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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