Osteonecrosis of the Jaw (ONJ) Case Registry

This study is currently recruiting participants.
Verified March 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01666106
First received: June 22, 2012
Last updated: March 21, 2014
Last verified: March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666106

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 44 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: March 21, 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 April 17, 2014