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

Osteonecrosis of the Jaw Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967160
• Other study ID #: 20101363
• Status: Completed
• Start date: January 2, 2012
• Est. completion date: August 5, 2019

Study information

• Verified date: September 2021
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2560
• Est. completion date: August 5, 2019
• Est. primary completion date: August 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection Leading to Hospitalization
• Infections
• Osteonecrosis
• Osteonecrosis of the Jaw

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	Aarhus University Hospital

References & Publications (1)

Acquavella J, Ehrenstein V, Schiodt M, Heide-Jorgensen U, Kjellman A, Hansen S, Larsson Wexell C, Herlofson BB, Noerholt SE, Ma H, Ohrling K, Hernandez RK, Sorensen HT. Design and methods for a Scandinavian pharmacovigilance study of osteonecrosis of the jaw and serious infections among cancer patients treated with antiresorptive agents for the prevention of skeletal-related events. Clin Epidemiol. 2016 Jul 20;8:267-72. doi: 10.2147/CLEP.S107270. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Incidence proportions of medically confirmed osteonecrosis of the jaw (ONJ) in XGEVA and zoledronic acid inception cohorts		5 years
Primary	2. Incidence proportions of infections leading to hospitalization in XGEVA and zoledronic acid inception cohorts		3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	4. Summarize oral risk factor information for medically confirmed ONJ cases		5 years
Secondary	5. Summarize for medically confirmed ONJ cases information on ONJ stage, treatment, clinical course, and resolution		5 years

External Links

•   AmgenTrials clinical trials website