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Osteonecrosis of the Jaw (ONJ) Case Registry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01666106
First received: June 22, 2012
Last updated: June 19, 2017
Last verified: June 2017
  Purpose
Osteonecrosis of the Jaw (ONJ) Case Registry

Condition
Osteonecrosis of the Jaw

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Osteonecrosis of the Jaw (ONJ) Case Registry

Resource links provided by NLM:


Further study details as provided by Amgen:

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

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

Enrollment: 327
Actual Study Start Date: October 1, 2012
Estimated Study Completion Date: April 9, 2021
Estimated Primary Completion Date: April 9, 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subjects with cancer and ONJ
Subjects with cancer and positively adjudicated ONJ

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.
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 22, 2012
Last Updated: June 19, 2017

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

ClinicalTrials.gov processed this record on September 21, 2017