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

Amgen

Status: Completed

Conditions: Osteonecrosis of the Jaw; Infection Leading to Hospitalization

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01967160

20101363

Details and patient eligibility

About

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.

Enrollment: 2,560 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

2,560 participants in 3 patient groups

XGEVA inception cohort

Description:

Patients with cancer who are naïve to oral or IV bisphosphonate treatment at the dose indicated for SRE prevention and who begin treatment with XGEVA at any time during the treatment cohort identification period

Zoledronic acid inception cohort

Description:

Patients with cancer who are naïve to oral or IV bisphosphonate treatment at the dose indicated for SRE prevention and who begin treatment with IV zoledronic acid at any time during the treatment cohort identification period

XGEVA-switch cohort

Description:

Patients with cancer who switch to XGEVA during treatment cohort identification period after having started antiresorptive therapy at the dose indicated for SRE prevention of no more than 2 years duration with bisphosphonates (\<24 IV infusions or \<24 monthly oral prescriptions)