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Completed

NCT Number: NCT01967160

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

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.

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Key information

Conditions

Osteonecrosis of the Jaw Infection Leading to Hospitalization

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 1. Incidence proportions of medically confirmed osteonecrosis of the jaw (ONJ) in XGEVA and zoledronic acid inception cohorts

    Time frame: 5 years

  2. 2. Incidence proportions of infections leading to hospitalization in XGEVA and zoledronic acid inception cohorts

    Time frame: 3 years

Secondary outcomes

  1. 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

    Time frame: 5 years

  2. 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

    Time frame: 5 years

  3. 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

    Time frame: 5 years

  4. 4. Summarize oral risk factor information for medically confirmed ONJ cases

    Time frame: 5 years

  5. 5. Summarize for medically confirmed ONJ cases information on ONJ stage, treatment, clinical course, and resolution

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • Aarhus University Hospital

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2013
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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