Hip FracturesCSHFENCT03461237
Chinese Second Hip Fracture Evaluation
An observational study of Hip Fractures and Osteoporosis, run by Beijing Jishuitan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 50 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures, Osteoporosis
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing ji shui tan hospital
Beijing, Beijing Municipality, 100035
Xiaoguang Cheng, MD, 0086-010-58516947, xiao65@263.net
Ling Wang, MD, 0086-010-58516688 ext. 6196, 1988yisheng@163.com
About this study
Official title: Second Hip Fracture Evaluation in Chinese Elderly Patients Using Quantitative Computed Tomography
- To Compare overall rates of second hip fractures in both genders,
- To determine the effect of hip fracture on proximal femoral volumetric bone mineral density (vBMD), bone structure and muscle by quantitative computed tomography(QCT),
- To evaluate the contribution of QCT-image analysis to the prediction of the second hip fracture risk.
- To identify the differences between femoral neck fracture and trochanter fracture following hip fracture
Read the 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.
- Conditions
- Hip Fractures, Osteoporosis
- Keywords
- Second Hip Fracture, Quantitative Computed Tomography, Bone structure, Muscle
- Medical subject headings
- Hip Fractures, Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip re-fracture
The incidence and location of second hip fracture
Measured: 3 years
all cause death
all cause death
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 May 2017
- Primary completionMay 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiaoguang Cheng, Beijing Jishuitan Hospital
- Investigators
- Xiaoguang Cheng, MD, Principal investigator, department of radiology, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461237
- Sponsor's protocol ID
- JST2016CSHFE
- Acronym
- CSHFE
- Status last verified
- Feb 2025
- First submitted
- 5 Mar 2018
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ma Y, Ge Y, Guo Z, Su Y, Wang C, Wang Q, Wang L, Cheng X, Yang M, Yan D. Hip structural analysis parameters are not associated with the risk of postmenopausal female second hip fracture: a retrospective study. BMC Musculoskelet Disord. 2025 Mar 10;26(1):233. doi: 10.1186/s12891-025-08368-7.
PubMed 40065296
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Hip Fracture Evaluation in Chinese Elderly Patients Using Quantitative Computed Tomography
- ClinicalTrials.gov ID
- NCT03461237
- Acronym / sponsor ID
- CSHFE / JST2016CSHFE
- Conditions
- Hip Fractures, Osteoporosis
- Keywords
- Second Hip Fracture, Quantitative Computed Tomography, Bone structure, Muscle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To Compare overall rates of second hip fractures in both genders,
- To determine the effect of hip fracture on proximal femoral volumetric bone mineral density (vBMD), bone structure and muscle by quantitative computed tomography(QCT),
- To evaluate the contribution of QCT-image analysis to the prediction of the second hip fracture risk.
- To identify the differences between femoral neck fracture and trochanter fracture following hip fracture
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hip re-fracture
Time frame: 3 years
The incidence and location of second hip fracture
all cause death
Time frame: 2 year
all cause death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Derived from this study: PubMed 40065296Ma Y, Ge Y, Guo Z, Su Y, Wang C, Wang Q, Wang L, Cheng X, Yang M, Yan D. Hip structural analysis parameters are not associated with the risk of postmenopausal female second hip fracture: a retrospective study. BMC Musculoskelet Disord. 2025 Mar 10;26(1):233. doi: 10.1186/s12891-025-08368-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoguang Cheng, MD principal investigator
department of radiology, Beijing Jishuitan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Osteoporosis, run by Beijing Jishuitan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoguang Cheng, MD (0086-010-58516947, xiao65@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip re-fracture (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03461237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.