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Characteristics and Outcomes of Odontoid Fragility Fractures in Elderly (FOOP)

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ClinicalTrials.gov Identifier: NCT02800278
Recruitment Status : Unknown
Verified June 2016 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief 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. 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

Condition or disease Intervention/treatment
Odontoid Fracture Osteoporosis Surgery Other: observational

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

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characteristics and Outcomes of Odontoid Fragility Fractures in Elderly
Study Start Date : January 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: observational
    describe bone status and outcome of odontoid fracture


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients over 65 y admitted for low traumat odontoid fracture
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patient < 65 y
  • traumatic odontoid fracture

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800278


Contacts
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Contact: veronique Breuil, MD PhD 33 4 920 35 512 breuil.v@chu-nice.fr

Locations
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France
CHU Recruiting
Nice, France, 06000
Contact: veronique Breuil, MD, PhD    +33492035512    breuil.v@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: veronique breuil, MD, PhD Centre Hospitalier Universitaire de Nice
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02800278    
Other Study ID Numbers: CHU de Nice RHUM
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Osteoporosis
Fractures, Bone
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases