Chinese Second Hip Fracture Evaluation

Osteoporosis Clinical Trial

— CSHFE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03461237
• Other study ID #: JST2016CSHFE
• Status: Recruiting
• Start date: May 1, 2017
• Est. completion date: November 2022

Study information

• Verified date: November 2021
• Source: Beijing Jishuitan Hospital
• Contact: Xiaoguang Cheng, MD
• Phone: 0086-010-58516947
• Email: xiao65[@]263.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: November 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Osteoporosis

Locations

Country	Name	City	State
China	Beijing ji shui tan hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hip re-fracture	The incidence and location of second hip fracture	3 years
Primary	all cause death	all cause death	2 year