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

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ClinicalTrials.gov Identifier: NCT01967160
Recruitment Status : Active, not recruiting
First Posted : October 22, 2013
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Amgen

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.

Condition or disease
Osteonecrosis of the Jaw Infection Leading to Hospitalization

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Study Type : Observational
Actual Enrollment : 2560 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : October 1, 2011
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis

Group/Cohort
XGEVA inception cohort
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
Zoledronic acid inception cohort
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
XGEVA-switch cohort
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 Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cancer patients treated with antiresorptive therapies for SRE prevention
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967160


Sponsors and Collaborators
Amgen
Aarhus University Hospital
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01967160     History of Changes
Other Study ID Numbers: 20101363
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Zoledronic Acid
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs