Trial record 18 of 118 for:
osteonecrosis
Osteonecrosis of the Jaw (ONJ) Case Registry
This study is currently recruiting participants.
Verified April 2013 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01666106
First received: June 22, 2012
Last updated: April 23, 2013
Last verified: April 2013
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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
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Contacts
| Contact: Amgen Call Center | 866-572-6436 |
Show 29 Study LocationsSponsors 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: | April 23, 2013 |
| 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 May 16, 2013