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OpenTrials
Completed

NCT Number: NCT02800278

Characteristics and Outcomes of Odontoid Fragility Fractures in Elderly

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

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Key information

Conditions

Odontoid Fracture Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Surgery

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU

Nice, 06000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients over 65 y admitted for low traumat odontoid fracture

Exclusion criteria

  • patient < 65 y
  • traumatic odontoid fracture

Treatment and study plan

Observational

Other

describe bone status and outcome of odontoid fracture

Primary outcomes

  1. 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

Secondary outcomes

  1. mortality

    Time frame: during hospitalization - 3 and 12 months after inclusion

    mortality after odontoid fracture during hospitalization and at 3 and 12 monts

  2. morbidity

    Time frame: during hospitalization - 3 and 12 months after inclusion

    incident osteoporotic fracture, adverse event such as infection, cardiovascular event, neurological event

  3. loss of autonomy

    Time frame: discharge, 3 and 12 months

    lenght of hospital stay, type of discharge (home, nursing home, rehabilitation bed care, institutionalized accomodation

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: FOOP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2016
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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