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Chinese Second Hip Fracture Evaluation (CSHFE)

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ClinicalTrials.gov Identifier: NCT03461237
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
xiaoguang Cheng, Beijing Jishuitan Hospital

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
Hip Fractures Osteoporosis

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 Type : Observational
Estimated 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
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Hip re-fracture [ Time Frame: 3 years ]
    The incidence and location of second hip fracture


Secondary Outcome Measures :
  1. Serum bone metabolic markers [ Time Frame: 3 years ]
    Serum bone metabolic markers

  2. Hip bone mineral density (BMD) [ Time Frame: 3 years ]
    Hip BMD measurement



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Ages Eligible for Study:   47 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This is a cohort-based study. 3000 participants (including 1800 females and 1200 males) who (>47 years old) have recently suffered single hip fracture will be recruited to the study.
Criteria

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

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): NCT03461237


Contacts
Contact: Xiaoguang Cheng, MD 0086-010-58516947 xiao65@263.net
Contact: Yongbin Su, MD 0086-010-58516688 ext 6196 dazaiqianyuan@126.com

Locations
China, Beijing
Beijing ji shui tan hospital Recruiting
Beijing, Beijing, China, 100035
Contact: Xiaoguang Cheng, MD    0086-010-58516947    xiao65@263.net   
Contact: Yongbin Su, MD    0086-010-58516688 ext 6196    dazaiqianyuan@126.com   
Sub-Investigator: Ling Wang, MD         
Sub-Investigator: Yimin Ma, MD         
Sub-Investigator: Li Xu, MD         
Sponsors and Collaborators
Beijing Jishuitan Hospital
Investigators
Principal Investigator: Xiaoguang Cheng, MD department of radiology, Beijing Jishuitan Hospital

Responsible Party: xiaoguang Cheng, Chairman, Department of Radiology, Beijing Jishuitan Hospital
ClinicalTrials.gov Identifier: NCT03461237     History of Changes
Other Study ID Numbers: JST2016CSHFE
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by xiaoguang Cheng, Beijing Jishuitan Hospital:
Second Hip Fracture
Quantitative Computed Tomography
Bone structure
Muscle

Additional relevant MeSH terms:
Hip Fractures
Fractures, Bone
Osteoporosis
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Femoral Fractures
Hip Injuries
Leg Injuries