Osteonecrosis of the JawNCT01666106
Osteonecrosis of the Jaw (ONJ) Case Registry
An observational study of Osteonecrosis of the Jaw, run by Amgen at 64 sites in 11 countries.
Trial summary
Osteonecrosis of the Jaw (ONJ) Case Registry Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteonecrosis of the Jaw
- How many people
- 327 participants
- Where
- 64 sitesin 11 countries
- Study dates
- 1 Oct 2012to 16 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with cancer and ONJ
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
64 sites in 11 countries.
64 sites in 11 countries
United States22 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Baltimore, Maryland, 21201
Research Site
Beverly Hills, California, 90211
Research Site
Buffalo, New York, 14215
Research Site
Buffalo, New York, 14263
Research Site
Charlotte, North Carolina, 28232
Research Site
Chicago, Illinois, 60612
Research Site
Cleveland, Ohio, 44106
Research Site
Council Bluffs, Iowa, 51503
Research Site
Denver, Colorado, 80019
Research Site
Duarte, California, 91010
Research Site
Farmington, Connecticut, 06030
Research Site
Gainesville, Florida, 32611
Research Site
Houston, Texas, 77030
Research Site
Memphis, Tennessee, 38120
Research Site
Mineola, New York, 11501
Research Site
Nashville, Tennessee, 37232
Research Site
Omaha, Nebraska, 68105
Research Site
Omaha, Nebraska, 68130
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Stratford, Connecticut, 06615
Research Site
Washington D.C., District of Columbia, 20010
Germany8 sites
Research Site
Berlin, 12200
Research Site
Berlin, 13055
Research Site
Cologne, 50677
Research Site
Düsseldorf, 40225
Research Site
Mühlhausen, 99974
Research Site
München, 80335
Research Site
München, 80337
Research Site
Regensburg, 93053
Canada5 sites
Research Site
Greater Sudbury, Ontario, P3E 5J1
Research Site
Halifax, Nova Scotia, B3H 2Y4
Research Site
Kitchener, Ontario, N2N 2B9
Research Site
Québec, Quebec, G1S 4L8
Research Site
Sault Ste. Marie, Ontario, P6B 0A8
France5 sites
Research Site
Bordeaux, 33075
Research Site
Brest, 29609
Research Site
Lyon, 69008
Research Site
Paris, 75651
Research Site
Saint-Herblain, 44800
Italy5 sites
Research Site
Alessandria, 15121
Research Site
Brescia, 25123
Research Site
Lecce, 73100
Research Site
Roma, 00128
Research Site
Torino, 10100
Greece4 sites
Research Site
Athens, 11527
Research Site
Athens, 11528
Research Site
Thessaloniki, 54121
Research Site
Thessaloniki, 57010
Spain4 sites
Research Site
Barcelona, Catalonia, 08003
Research Site
Madrid, 28009
Research Site
Madrid, 28041
Research Site
Seville, Andalusia, 41013
Belgium3 sites
Research Site
Brussels, 1000
Research Site
Edegem, 2650
Research Site
Leuven, 3000
Finland3 sites
Research Site
Helsinki, 00029
Research Site
Kuopio, 70211
Research Site
Oulu, 90029
United Kingdom3 sites
Research Site
Cardiff, CF14 4XY
Research Site
London, WC1X 8LD
Research Site
Sheffield, S10 2SJ
About this study
Osteonecrosis of the Jaw (ONJ) Case Registry
Read the 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.
- Conditions
- Osteonecrosis of the Jaw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with cancer and ONJ | Subjects with cancer and positively adjudicated ONJ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution rate and time to ONJ resolution
- Resolution: complete coverage of the exposed bone by mucosa in the absence of clinical symptoms
- Improvement: a decrease in the stage or severity of the lesion
- Progression: an increase in the stage or severity of the lesion
- Stable: not resolved, improved, or progressed
Measured: 5 years
Secondary outcomes (4)
The clinical features of ONJ, including severity and staging at enrollment
Measured: 5 years
The frequency of risk factors for incident ONJ
Characterize the frequency of risk factors for incident ONJ such as a history of inflammatory dental disease (periodontal and dental abscesses), dentoalveolar procedures, smoking, use of antiangiogenic agents, and duration/dosing regimens of antiresorptive medications prior to the development of ONJ
Measured: 5 years
Therapeutic treatment patterns for ONJ
Characterize treatment patterns of antiresorptive medications subsequent to incident ONJ such as the proportion of subjects who continue to be treated with antiresorptive medications by specific agents and ONJ severity and stage
Measured: 5 years
Treatment patterns of antiresorptive agents subsequent to incident ONJ
Characterize subsequent treatment patterns for ONJ including antimicrobial oral rinses, antibiotics, and surgery
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study start1 Oct 2012
- Primary completion16 Dec 2020
- Study completion16 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteonecrosis of the JawStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666106
- Sponsor's protocol ID
- 20101102
- Status last verified
- Dec 2020
- First submitted
- 22 Jun 2012
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Publications
Schiodt M, Vadhan-Raj S, Chambers MS, Nicolatou-Galitis O, Politis C, Coropciuc R, Fedele S, Jandial D, Zhang J, Ma H, Saunders DP. A multicenter case registry study on medication-related osteonecrosis of the jaw in patients with advanced cancer. Support Care Cancer. 2018 Jun;26(6):1905-1915. doi: 10.1007/s00520-017-4003-2. Epub 2017 Dec 23.
PubMed 29275525
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteonecrosis of the Jaw (ONJ) Case Registry
- ClinicalTrials.gov ID
- NCT01666106
- Acronym / sponsor ID
- 20101102
- Conditions
- Osteonecrosis of the Jaw
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteonecrosis of the Jaw (ONJ) Case Registry
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with cancer and ONJ | – | –Subjects with cancer and positively adjudicated ONJ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with cancer and ONJ
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resolution rate and time to ONJ resolution
Time frame: 5 years
* Resolution: complete coverage of the exposed bone by mucosa in the absence of clinical symptoms * Improvement: a decrease in the stage or severity of the lesion * Progression: an increase in the stage or severity of the lesion * Stable: not resolved, improved, or progressed
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Background: PubMed 29275525Schiodt M, Vadhan-Raj S, Chambers MS, Nicolatou-Galitis O, Politis C, Coropciuc R, Fedele S, Jandial D, Zhang J, Ma H, Saunders DP. A multicenter case registry study on medication-related osteonecrosis of the jaw in patients with advanced cancer. Support Care Cancer. 2018 Jun;26(6):1905-1915. doi: 10.1007/s00520-017-4003-2. Epub 2017 Dec 23.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
64 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteonecrosis of the Jaw, run by Amgen at 64 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, Germany, Canada, France, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution rate and time to ONJ resolution (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01666106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.