CSHFE: Chinese Second Hip Fracture Evaluation

Sponsor
Beijing Jishuitan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03461237
Collaborator
(none)
3,000
1
66
45.4

Study Details

Study Description

Brief Summary

  1. To Compare overall rates of second hip fractures in both genders,

  2. To determine the effect of hip fracture on proximal femoral volumetric bone mineral density (vBMD), bone structure and muscle by quantitative computed tomography(QCT),

  3. To evaluate the contribution of QCT-image analysis to the prediction of the second hip fracture risk.

  4. To identify the differences between femoral neck fracture and trochanter fracture following hip fracture

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Osteoporotic hip fracture is a great harm among elderly people, for whom disability and death often occurs. Furthermore, sustaining an osteoporotic hip fracture increases the risk of a subsequent fracture. However, the risk factors of subsequent hip fractures are less studied and the proximal femur bone structure and muscle changes following first hip fracture are little known.

    Therefore, we propose to conduct an observational and perspective study to assess the effect of hip fracture on proximal femoral bone and muscle using quantitative computed tomography (QCT), as well as to evaluate the contribution of QCT-image analysis to the prediction of the second hip fracture risk. As hip fractures are divided into two major anatomic based types in clinical: femoral neck fractures (intracapsular) and trochanter fractures (extracapsular), the fundamental objective also includes identifying bone and muscle differences in a union activity between the two type fractures. Compared with duel-energy x-ray absorptiometry (DXA), QCT offers the advantage of selective measurement of the metabolically active and structurally important trabecular bone in the proximal femoral. Volumetric BMD and structure of proximal femoral and muscle around hip will be measured with QCT. The CT scanner will be the clinical CT scanner of the local participated center. Quality control and monitoring will be conducted by Beijing Jishuitan hospital, as well as the centralised image interpretation.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Second Hip Fracture Evaluation in Chinese Elderly Patients Using Quantitative Computed Tomography
    Actual Study Start Date :
    May 1, 2017
    Anticipated Primary Completion Date :
    May 1, 2022
    Anticipated Study Completion Date :
    Nov 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Hip re-fracture [3 years]

      The incidence and location of second hip fracture

    2. all cause death [2 year]

      all cause death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • a:Osteoporotic patients b:Osteoporotic hip fracture patients (femoral neck fracture and femoral trochanteric fracture) c: Be willing to and be able to join in the study and sighed the informed consent
    Exclusion Criteria:
    • a:Under 47years old b:Non-surgical repair of hip fracture c:Pathologic fracture d:Violence-related trauma e:Bilateral hip implants or have hip replacement on the non-fractured side

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing ji shui tan hospital Beijing Beijing China 100035

    Sponsors and Collaborators

    • Beijing Jishuitan Hospital

    Investigators

    • Principal Investigator: Xiaoguang Cheng, MD, department of radiology, Beijing Jishuitan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    xiaoguang Cheng, Chairman, Department of Radiology, Beijing Jishuitan Hospital
    ClinicalTrials.gov Identifier:
    NCT03461237
    Other Study ID Numbers:
    • JST2016CSHFE
    First Posted:
    Mar 9, 2018
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by xiaoguang Cheng, Chairman, Department of Radiology, Beijing Jishuitan Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 18, 2021