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

N/ACompletedNCT01967160

Amgen2,560 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

2,560

Conditions

Osteonecrosis of the Jaw Infection Leading to Hospitalization

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

1. Incidence proportions of medically confirmed osteonecrosis of the jaw (ONJ) in XGEVA and zoledronic acid inception cohorts

Time frame: 5 years

2. Incidence proportions of infections leading to hospitalization in XGEVA and zoledronic acid inception cohorts

Time frame: 3 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

Time frame: 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

Time frame: 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

Time frame: 5 years

4. Summarize oral risk factor information for medically confirmed ONJ cases

Time frame: 5 years

5. Summarize for medically confirmed ONJ cases information on ONJ stage, treatment, clinical course, and resolution

Time frame: 5 years

Data from ClinicalTrials.gov

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