Overview

This trial is active, not recruiting.

Conditions onj, infection
Sponsor Amgen
Collaborator Aarhus University Hospital
Start date October 2011
End date September 2019
Trial size 2100 participants
Trial identifier NCT01967160, 20101363

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
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

Measure
1. Incidence proportions of medically confirmed ONJ in the cohort switching from IV bisphosphonate to XGEVA
time frame: 5 years
2. Incidence proportions of medically confirmed ONJ in the cohort switching from IV bisphosphonate to XGEVA stratified by number of prior cancer-related bisphosphonate treatments
time frame: 5 years
3. Number of bisphosphonate treatments prior to initiation of XGEVA treatment for patients in the cohort switching from IV bisphosphonate to XGEVA
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

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 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 indication for treatment with an anti-resorptive agent

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Amgen.