Odontoid FractureFOOPNCT02800278
Characteristics and Outcomes of Odontoid Fragility Fractures in Elderly
An observational study of Odontoid Fracture and Osteoporosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Usually, cervical spine fractures are not considered as osteoporotic fractures. However, recent studies show that odontoid fractures are the most common fractures of the cervical spine in elderly and may occur in a context of low trauma energy. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Odontoid Fracture, Osteoporosis, Surgery
- What is being tested?
- observational
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to 31 Dec 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: all patients over 65 y admitted for low traumat odontoid fracture
Who may be able to join
- all patients over 65 y admitted for low traumat odontoid fracture
Who cannot join
- patient < 65 y
- traumatic odontoid fracture
Trial locations and contacts
1 site in 1 country.
About this study
Usually, cervical spine fractures are not considered as osteoporotic fractures. However, recent studies show that odontoid fractures are the most common fractures of the cervical spine in elderly and may occur in a context of low trauma energy. Thus, the goal of this observationnal study is :
- to describe the different type of odontoid fracture and to characterize bone status in elderly patient (>65 y) who underwent odontoid fracture in a context of low trauma energy.
- To describe short and long term outcomes
Read the detailed description
All patients over 65 y admitted for low trauma odontoid fracture will be consecutively included in the study after informed consent. The investigators will record:
- clinical risk factor of osteoporosis and health habits including accomodation
- type of fracture and characterization of the odontoid fracture on imaging (standard X ray / MRI / QCT)
- Bone status : bone mineral density on DXA, lab tests for secondary osteoporosis check-up, previous vertebral fracture on VFA or X ray
- osteoporosis managment : nutrition, vitamin D, anti-osteoporotic drugs
- treatment of the fracture : surgical / non surgical
- adverse event during hospitalization
- lenght of hospital stay
- type of discharge
Follow-up à 3 and 12 months : dead vs alive ; accomodation ; autonomy ; new fracture
- Conditions
- Odontoid Fracture, Osteoporosis, Surgery
- Being tested
- observational
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
describe bone status and outcome of odontoid fracture
What is being measured
The primary outcome is the main question the study is designed to answer.
bone status at the time of odontoid fracture: bone mineral density, prevalent osteoporotic fracture, vitamin D status
clinical risk factor of osteoporosis, prevalent clinical osteoporotic fracture, bone mineral density measured by DXA, vertebral fracture assessment to detect other vertebral fracture, serum concentration in 25OHvitamin D
Measured: from date of inclusion until to 3 weeks after the event. Inclusion will be proposed within 2 weeks after the fracture
Secondary outcomes (3)
mortality
mortality after odontoid fracture during hospitalization and at 3 and 12 monts
Measured: during hospitalization - 3 and 12 months after inclusion
morbidity
incident osteoporotic fracture, adverse event such as infection, cardiovascular event, neurological event
Measured: during hospitalization - 3 and 12 months after inclusion
loss of autonomy
lenght of hospital stay, type of discharge (home, nursing home, rehabilitation bed care, institutionalized accomodation
Measured: discharge, 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Odontoid FractureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- veronique breuil, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800278
- Sponsor's protocol ID
- CHU de Nice RHUM
- Acronym
- FOOP
- Status last verified
- Jun 2016
- First submitted
- 18 May 2016
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Outcomes of Odontoid Fragility Fractures in Elderly
- ClinicalTrials.gov ID
- NCT02800278
- Acronym / sponsor ID
- FOOP / CHU de Nice RHUM
- Conditions
- Odontoid Fracture, Osteoporosis, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 15 Jun 2016 (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.
Usually, cervical spine fractures are not considered as osteoporotic fractures. However, recent studies show that odontoid fractures are the most common fractures of the cervical spine in elderly and may occur in a context of low trauma energy. Thus, the goal of this observationnal study is :
- to describe the different type of odontoid fracture and to characterize bone status in elderly patient (>65 y) who underwent odontoid fracture in a context of low trauma energy.
- To describe short and long term outcomes
Detailed description
All patients over 65 y admitted for low trauma odontoid fracture will be consecutively included in the study after informed consent. The investigators will record:
- clinical risk factor of osteoporosis and health habits including accomodation
- type of fracture and characterization of the odontoid fracture on imaging (standard X ray / MRI / QCT)
- Bone status : bone mineral density on DXA, lab tests for secondary osteoporosis check-up, previous vertebral fracture on VFA or X ray
- osteoporosis managment : nutrition, vitamin D, anti-osteoporotic drugs
- treatment of the fracture : surgical / non surgical
- adverse event during hospitalization
- lenght of hospital stay
- type of discharge
Follow-up à 3 and 12 months : dead vs alive ; accomodation ; autonomy ; new fracture
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- all patients over 65 y admitted for low traumat odontoid fracture
Key inclusion criteria (1 listed)
- all patients over 65 y admitted for low traumat odontoid fracture
Key exclusion criteria (2 listed)
- patient < 65 y
- traumatic odontoid fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationaldescribe bone status and outcome of odontoid fracture | Other | – |
Primary outcome
bone status at the time of odontoid fracture: bone mineral density, prevalent osteoporotic fracture, vitamin D status
Time frame: from date of inclusion until to 3 weeks after the event. Inclusion will be proposed within 2 weeks after the fracture
clinical risk factor of osteoporosis, prevalent clinical osteoporotic fracture, bone mineral density measured by DXA, vertebral fracture assessment to detect other vertebral fracture, serum concentration in 25OHvitamin D
3 secondary outcomes
mortality
Time frame: during hospitalization - 3 and 12 months after inclusion
morbidity
Time frame: during hospitalization - 3 and 12 months after inclusion
loss of autonomy
Time frame: discharge, 3 and 12 months
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 2026.
- Individual participant dataSharing planned: No
Related trials for Odontoid Fracture
Recruiting
SCORE Study: Comparing Surgery and Rigid Collar Treatment for Odontoid Fractures in Adults Over 70
Odontoid Fracture, Elderly
Recruiting
Study on Orthosis in Cervical Spine Fracture Treatment
Cervical Spine Fractures, Cervical Spine Injury
Not yet recruitingObservational study
Outcomes of Fracture Odontoid Management
Odontoid Fracture
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.
veronique breuil, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nice
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 Odontoid Fracture and Osteoporosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 2 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 2026. 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 France. 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?
bone status at the time of odontoid fracture: bone mineral density, prevalent osteoporotic fracture, vitamin D status (time frame: from date of inclusion until to 3 weeks after the event. Inclusion will be proposed within 2 weeks after the fracture). It is what the study was designed to measure, not a finding.
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 2026.