Osteonecrosis of the Jaw (ONJ) Case Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01666106
First received: June 22, 2012
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

Osteonecrosis of the Jaw (ONJ) Case Registry


Condition
Osteonecrosis of the Jaw (ONJ)

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Explore the relationship between rate and time to ONJ resolution with ONJ severity and staging at Registry enrollment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Explore the relationship between rate and time to ONJ resolution with potential risk factors [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Explore the relationship between rate and time to ONJ resolution and subsequent treatment patterns for ONJ [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Explore the relationship between rate and time to ONJ resolution and treatment patterns of antiresorptive therapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: March 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
Genders Eligible for Study:   Both
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 maxillofacial area administered for therapeutic intent in 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

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 54 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

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, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Ethics Review Committee
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Haute Autorité de Santé Transparency Commission
France: Institutional Ethical Committee
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014