Clinical trial NCT01967160: Osteonecrosis of the Jaw (ONJ) and Infection Among Nordic Cancer Patients Treated With XGEVA™ or Zoledronic Acid
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteonecrosis of the Jaw
Infection Leading to Hospitalization
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Aarhus University Hospital
First posted: 2013-10-22
Enrollment: 2560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer patients treated with antiresorptive therapies for SRE prevention

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.


Eligibility criteria: 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

Primary outcomes:
measure: 1. Incidence proportions of medically confirmed osteonecrosis of the jaw (ONJ) in XGEVA and zoledronic acid inception cohorts
timeFrame: 5 years
measure: 2. Incidence proportions of infections leading to hospitalization in XGEVA and zoledronic acid inception cohorts
timeFrame: 3 years
Secondary outcomes:
measure: 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
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: 4. Summarize oral risk factor information for medically confirmed ONJ cases
timeFrame: 5 years
measure: 5. Summarize for medically confirmed ONJ cases information on ONJ stage, treatment, clinical course, and resolution
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.