Clinical trial · Observational
Osteonecrosis of the Jaw (ONJ) and Infection Among Nordic Cancer Patients Treated With XGEVA™ or Zoledronic Acid
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
NCT01967160CI-TRIAL-00067342completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infection Leading to Hospitalization | — | UNRESOLVED | — |
| Osteonecrosis of the Jaw | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- 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
- label
- 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
- label
- 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)
Primary outcomes (2)
- measure
- 1. Incidence proportions of medically confirmed osteonecrosis of the jaw (ONJ) in XGEVA and zoledronic acid inception cohorts
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDAcquavella 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. PMID 27499646