Osteonecrosis of the JawNCT01201330
DPBRN Retrospective Cohort Study of Osteonecrosis of the Jaw
An observational study of Osteonecrosis of the Jaw, run by Dental Practice-Based Research Network at 1 site in United States.
Trial summary
The purpose of this study was to determine the prevalence of ONJ in the patient population of 2 large HMOs and study the risk factors associated with the development of this condition. Read more about this study
- Who is it for?
- Ages 41 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteonecrosis of the Jaw
- How many people
- 572,606 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to May 2008
- 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 41 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients older than 40 with a history of jaw osteonecrosis and control patients with exposure to biphosphonates were included.
Who may be able to join
- ONJ sufferers and control biphosphonate users older than 40, of any gender, race and ethnic origin
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gregg H. Gilbert, DDS, MBA
Birmingham, Alabama, 35294-0007
About this study
Official title: Retrospective Cohort Study of ONJ
The purpose of this study was to determine the prevalence of ONJ in the patient population of 2 large HMOs and study the risk factors associated with the development of this condition.
Read the detailed description
The electronic database from Kaiser Permanente and HealthParnters of Minnesota were used to identify all ONJ cases that occured between 1994 and 2006 and then demographic, social and medical risk factors possibly associated with the disease were abstracted and analyzed.
- Conditions
- Osteonecrosis of the Jaw
- Keywords
- ONJ
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 |
|---|---|---|
| ONJ sufferers | history of jaw osteonecrosis | |
| Bisphosphonate exposure | patients with exposure to bisphosphonates |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteonecrosis of the JawStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 572,606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dental Practice-Based Research Network
- Sponsor type
- Research network
- Collaborators
- HealthPartners Institute, Kaiser Permanente, Permanente Dental Associates Group, Oregon, National Institute of Dental and Craniofacial Research (NIDCR)
- Investigators
- Jeffrey Fellows, Ph.D., Principal investigator, Kaiser PermanenteAndrei Barasch, DMD,MDSc, Principal investigator, University of Alabama at BirminghamBrad Rindal, DMD, Principal investigator, HealthPartners of MinnesotaGregg H Gilbert, DDS, MBA, Study chair, University of Alabama School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201330
- Sponsor's protocol ID
- 106030
- Other IDs
- U01DE016747
- Status last verified
- Jun 2011
- First submitted
- 13 Sep 2010
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cohort Study of ONJ
- ClinicalTrials.gov ID
- NCT01201330
- Acronym / sponsor ID
- 106030
- Conditions
- Osteonecrosis of the Jaw
- Keywords
- ONJ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 572,606 participants (actual)
- Lead sponsor
- Dental Practice-Based Research NetworkResearch network
- Collaborators
- HealthPartners Institute, Kaiser Permanente, Permanente Dental Associates Group, Oregon, National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 14 Sep 2010 (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.
The purpose of this study was to determine the prevalence of ONJ in the patient population of 2 large HMOs and study the risk factors associated with the development of this condition.
Detailed description
The electronic database from Kaiser Permanente and HealthParnters of Minnesota were used to identify all ONJ cases that occured between 1994 and 2006 and then demographic, social and medical risk factors possibly associated with the disease were abstracted and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONJ sufferers | – | –history of jaw osteonecrosis |
| Bisphosphonate exposure | – | –patients with exposure to bisphosphonates |
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients older than 40 with a history of jaw osteonecrosis and control patients with exposure to biphosphonates were included.
Key inclusion criteria (1 listed)
- ONJ sufferers and control biphosphonate users older than 40, of any gender, race and ethnic origin
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 16 Jun 2011.
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Comparing Implant Retention Versus Removal for MRONJ at Implant Sites
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Topical Oxygen Therapy for BRONJ
Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ), Oxygen
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Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw
Medication-related Osteonecrosis of the Jaw (MRONJ)
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.
Jeffrey Fellows, Ph.D. principal investigator
Kaiser Permanente
Andrei Barasch, DMD,MDSc principal investigator
University of Alabama at Birmingham
Brad Rindal, DMD principal investigator
HealthPartners of Minnesota
1 site in 1 country: 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 Dental Practice-Based Research Network at 1 site in United States.
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 1 inclusion and 0 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 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Where can I read the original study information?
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 16 Jun 2011.