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
Sponsor study identifier
observational
2,560
0 countries
N/A
Study Start
January 2, 2012
Actual (reported)Primary Completion
August 5, 2019
Actual (reported)Study Completion
August 5, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 5, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2, 2012
Actual (reported)October 18, 2013
Actual (reported)October 22, 2013
Actual (reported)August 5, 2019
Actual (reported)August 5, 2019
Actual (reported)1. Incidence proportions of medically confirmed osteonecrosis of the jaw (ONJ) in XGEVA and zoledronic acid inception cohorts
5 years
2. Incidence proportions of infections leading to hospitalization in XGEVA and zoledronic acid inception cohorts
3 years
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
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
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
4. Summarize oral risk factor information for medically confirmed ONJ cases
5 years
5. Summarize for medically confirmed ONJ cases information on ONJ stage, treatment, clinical course, and resolution
5 years
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
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
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)
Cancer patients treated with antiresorptive therapies for SRE prevention
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.
MD
Amgen
2,560 participants (actual enrollment reported by the registry).
First Submitted
October 18, 2013
First Posted
October 22, 2013
Study Start
January 2, 2012
Actual (reported)CONDOR Study of Osteonecrosis of the Jaws (TMJ)
Contact the study team to confirm eligibility.
Primary Completion
August 5, 2019
Actual (reported)Study Completion
August 5, 2019
Actual (reported)Last Updated
June 22, 2023
Record last verified: 2021-09
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Source: ClinicalTrials.gov.
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