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Osteonecrosis of the Jaw (ONJ) Case Registry

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ClinicalTrials.gov Identifier: NCT01666106
Recruitment Status : Active, not recruiting
First Posted : August 16, 2012
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Osteonecrosis of the Jaw (ONJ) Case Registry

Condition or disease
Osteonecrosis of the Jaw

Detailed Description:
The purpose of the ONJ case registry is to describe the natural history of positively-adjudicated ONJ in subjects with cancer with an observation period of 5 years. Most of these subjects are expected to have received bone antiresorptive agents such as bisphosphonates or denosumab together with cancer-specific therapies (eg, chemotherapy, steroids, or anti-angiogenics). It is also possible that the registry will include subjects with cancer who developed ONJ without exposure to any antiresorptive therapy.

Study Design

Study Type : Observational
Actual Enrollment : 327 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Osteonecrosis of the Jaw (ONJ) Case Registry
Actual Study Start Date : October 1, 2012
Estimated Primary Completion Date : April 9, 2021
Estimated Study Completion Date : April 9, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Subjects with cancer and ONJ
Subjects with cancer and positively adjudicated ONJ


Outcome Measures

Primary Outcome Measures :
  1. Resolution rate and time to ONJ resolution [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. The clinical features of ONJ, including severity and staging at enrollment [ Time Frame: 5 years ]
  2. The frequency of risk factors for incident ONJ [ Time Frame: 5 years ]
  3. Therapeutic treatment patterns for ONJ [ Time Frame: 5 years ]
  4. Treatment patterns of antiresorptive agents subsequent to incident ONJ [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with cancer and ONJ
Criteria

Inclusion Criteria:

  • Adult (≥18 years of age) with diagnosis of cancer
  • Newly diagnosed, positively-adjudicated ONJ
  • ECOG <=2 and expected survival ≥3 months
  • Willing to provide access to previous and future medical and dental information
  • Subject or subject's legally acceptable representative has provided written informed consent

Exclusion Criteria:

  • History of radiation to the jaws administered for the treatment of cancer
  • Subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge.
  • Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
Contacts and Locations

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): NCT01666106


  Show 64 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01666106     History of Changes
Other Study ID Numbers: 20101102
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes