Chinese Second Hip Fracture Evaluation (CSHFE)

Second Hip Fracture Evaluation in Chinese Elderly Patients Using Quantitative Computed Tomography

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

Study Overview

• Status: Recruiting
• Conditions: 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
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Yongbin Su, MD; Phone Number: 6196 0086-010-58516688; Email: dazaiqianyuan@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100035
      • Recruiting
      • Beijing Ji Shui Tan Hospital
      • Contact: Ling Wang, MD; Phone Number: 6196 0086-010-58516688; Email: 1988yisheng@163.com
      • Sub-Investigator: Ling Wang, MD
      • Sub-Investigator: Yimin Ma, MD
      • Sub-Investigator: Li Xu, MD
      • Sub-Investigator: yongbin Su, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip re-fracture	The incidence and location of second hip fracture	3 years
all cause death	all cause death	2 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Muscle; Bone structure; Second Hip Fracture; Quantitative Computed Tomography
• Additional Relevant MeSH Terms: Metabolic Diseases; Wounds and Injuries; Leg Injuries; Musculoskeletal Diseases; Bone Diseases; Femoral Fractures; Hip Injuries; Bone Diseases, Metabolic; Fractures, Bone; Hip Fractures; Osteoporosis
• Other Study ID Numbers: JST2016CSHFE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO