Femoral Neck FracturesNCT02750046
Study of A Special Vessel Subtype in Bone Samples From Patients With Osteoporotic and Nonosteoporotic Fracture
A study testing total hip arthroplasty or proximal femoral nails in people with Femoral Neck Fractures, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
RATIONALE: Collecting and storing bone samples from patients with osteoporotic and nonosteoporotic fracture to study a special vessel subtype in the laboratory may help surgeon learn more about the relationship between bone mineral density (BMD) and a special vessel subtype (type H vessel). Read more about this study
- Who is it for?
- Ages 60 to 75 years, women only
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- total hip arthroplasty or proximal femoral nails
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages Eligible for Study: 65-75 Years
- Genders Eligible for Study: Woman
- Accepts Healthy Volunteers: NO
- Study Population: Female patients with hip fracture. -
Who cannot join
- Malignancy or benign ovarian cysts
- Known chronic or systemic diseases
- Hormone therapy in the previous 3 months
- Bone metabolism and drug therapy
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: Collection of Bone Specimens for Testing of A Special Vessel Subtype
RATIONALE: Collecting and storing bone samples from patients with osteoporotic and nonosteoporotic fracture to study a special vessel subtype in the laboratory may help surgeon learn more about the relationship between bone mineral density (BMD) and a special vessel subtype (type H vessel).
PURPOSE: This research study is looking at changes of a special vessel subtype in bone samples from patients with osteoporotic and nonosteoporotic fracture.
Read the detailed description
OBJECTIVES:
- Establish type H vessel in bone specimen in patients with hip fracture.
- Explore the correlation of BMD and type H vessel.
OUTLINE:
- Collect human bone specimens from patients with Osteoporotic and Nonosteoporotic Fracture.
- Provide a repository for storage of tissue and make these specimens available for approved projects by laboratory-based investigators.
- Observe the type H vessel in bone slice by immunofluorescence staining.
- Collect clinical data on these patients including bone mineral density.
- Investigate the relationship between BMD and type H vessel.
- Conditions
- Femoral Neck Fractures
- Being tested
- total hip arthroplasty or proximal femoral nails
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total hip arthroplasty or proximal femoral nailsProcedure or surgery
Bone samples from Hip fracture were collected when total hip arthroplasty or proximal femoral nails was performed.
| Study group | Role | What they receive |
|---|---|---|
| osteoporotic fractures | Experimental | patients with osteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed. Receives: Procedure: total hip arthroplasty or proximal femoral nails |
| nonosteoporotic fractures | Sham comparator | patients with nonosteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed. Receives: Procedure: total hip arthroplasty or proximal femoral nails |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area of a special vessel subtype in human bone samples
Bone samples were fixed in 4% PFA, decalcified, dehydrated, embedded and immunofluorescent staining for 3 months. Calculate the proportion of the special vessel of total vessel.
Measured: 3 months
Secondary outcomes (2)
The value of bone mineral density
Bone mineral density was measured by double energy X-ray absorptiometer (DXA) in a week before surgery.
Measured: 1 week
Correlation of of bone mineral density and area of a special vessel subtype in human bone
Calculate correlation coefficient of BMD and type H vessel in human bone samples in 2 months.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youjia Xu, PhD. M.D., Study chair, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750046
- Sponsor's protocol ID
- SencondSoochowU
- Status last verified
- Apr 2016
- First submitted
- 24 Mar 2016
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Kusumbe AP, Ramasamy SK, Adams RH. Coupling of angiogenesis and osteogenesis by a specific vessel subtype in bone. Nature. 2014 Mar 20;507(7492):323-328. doi: 10.1038/nature13145. Epub 2014 Mar 12.
PubMed 24646994Xie H, Cui Z, Wang L, Xia Z, Hu Y, Xian L, Li C, Xie L, Crane J, Wan M, Zhen G, Bian Q, Yu B, Chang W, Qiu T, Pickarski M, Duong LT, Windle JJ, Luo X, Liao E, Cao X. PDGF-BB secreted by preosteoclasts induces angiogenesis during coupling with osteogenesis. Nat Med. 2014 Nov;20(11):1270-8. doi: 10.1038/nm.3668. Epub 2014 Oct 5.
PubMed 25282358Ramasamy SK, Kusumbe AP, Wang L, Adams RH. Endothelial Notch activity promotes angiogenesis and osteogenesis in bone. Nature. 2014 Mar 20;507(7492):376-380. doi: 10.1038/nature13146. Epub 2014 Mar 12.
PubMed 24647000Kusumbe AP, Adams RH. Osteoclast progenitors promote bone vascularization and osteogenesis. Nat Med. 2014 Nov;20(11):1238-40. doi: 10.1038/nm.3747. No abstract available.
PubMed 25375923Wang L, Zhou F, Zhang P, Wang H, Qu Z, Jia P, Yao Z, Shen G, Li G, Zhao G, Li J, Mao Y, Xie Z, Xu W, Xu Y, Xu Y. Human type H vessels are a sensitive biomarker of bone mass. Cell Death Dis. 2017 May 4;8(5):e2760. doi: 10.1038/cddis.2017.36.
PubMed 28471445
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Bone Specimens for Testing of A Special Vessel Subtype
- ClinicalTrials.gov ID
- NCT02750046
- Acronym / sponsor ID
- SencondSoochowU
- Conditions
- Femoral Neck Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 25 Apr 2016 (estimated)
- 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.
RATIONALE: Collecting and storing bone samples from patients with osteoporotic and nonosteoporotic fracture to study a special vessel subtype in the laboratory may help surgeon learn more about the relationship between bone mineral density (BMD) and a special vessel subtype (type H vessel).
PURPOSE: This research study is looking at changes of a special vessel subtype in bone samples from patients with osteoporotic and nonosteoporotic fracture.
Detailed description
OBJECTIVES:
- Establish type H vessel in bone specimen in patients with hip fracture.
- Explore the correlation of BMD and type H vessel.
OUTLINE:
- Collect human bone specimens from patients with Osteoporotic and Nonosteoporotic Fracture.
- Provide a repository for storage of tissue and make these specimens available for approved projects by laboratory-based investigators.
- Observe the type H vessel in bone slice by immunofluorescence staining.
- Collect clinical data on these patients including bone mineral density.
- Investigate the relationship between BMD and type H vessel.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| osteoporotic fractures | Experimental | Procedure: total hip arthroplasty or proximal femoral nailspatients with osteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed. |
| nonosteoporotic fractures | Sham comparator | Procedure: total hip arthroplasty or proximal femoral nailspatients with nonosteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages Eligible for Study: 65-75 Years
- Genders Eligible for Study: Woman
- Accepts Healthy Volunteers: NO
- Study Population: Female patients with hip fracture. -
Key exclusion criteria (4 listed)
- Malignancy or benign ovarian cysts
- Known chronic or systemic diseases
- Hormone therapy in the previous 3 months
- Bone metabolism and drug therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total hip arthroplasty or proximal femoral nailsBone samples from Hip fracture were collected when total hip arthroplasty or proximal femoral nails was performed. | Procedure or surgery | nonosteoporotic fractures, osteoporotic fractures |
Primary outcome
The area of a special vessel subtype in human bone samples
Time frame: 3 months
Bone samples were fixed in 4% PFA, decalcified, dehydrated, embedded and immunofluorescent staining for 3 months. Calculate the proportion of the special vessel of total vessel.
2 secondary outcomes
The value of bone mineral density
Time frame: 1 week
Correlation of of bone mineral density and area of a special vessel subtype in human bone
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
- Results publication: PubMed 24646994Kusumbe AP, Ramasamy SK, Adams RH. Coupling of angiogenesis and osteogenesis by a specific vessel subtype in bone. Nature. 2014 Mar 20;507(7492):323-328. doi: 10.1038/nature13145. Epub 2014 Mar 12.
- Results publication: PubMed 25282358Xie H, Cui Z, Wang L, Xia Z, Hu Y, Xian L, Li C, Xie L, Crane J, Wan M, Zhen G, Bian Q, Yu B, Chang W, Qiu T, Pickarski M, Duong LT, Windle JJ, Luo X, Liao E, Cao X. PDGF-BB secreted by preosteoclasts induces angiogenesis during coupling with osteogenesis. Nat Med. 2014 Nov;20(11):1270-8. doi: 10.1038/nm.3668. Epub 2014 Oct 5.
- Results publication: PubMed 24647000Ramasamy SK, Kusumbe AP, Wang L, Adams RH. Endothelial Notch activity promotes angiogenesis and osteogenesis in bone. Nature. 2014 Mar 20;507(7492):376-380. doi: 10.1038/nature13146. Epub 2014 Mar 12.
- Results publication: PubMed 25375923Kusumbe AP, Adams RH. Osteoclast progenitors promote bone vascularization and osteogenesis. Nat Med. 2014 Nov;20(11):1238-40. doi: 10.1038/nm.3747. No abstract available.
- Derived from this study: PubMed 28471445Wang L, Zhou F, Zhang P, Wang H, Qu Z, Jia P, Yao Z, Shen G, Li G, Zhao G, Li J, Mao Y, Xie Z, Xu W, Xu Y, Xu Y. Human type H vessels are a sensitive biomarker of bone mass. Cell Death Dis. 2017 May 4;8(5):e2760. doi: 10.1038/cddis.2017.36.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Youjia Xu, PhD. M.D. study chair
Second Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total hip arthroplasty or proximal femoral nails in people with Femoral Neck Fractures, run by Second Affiliated Hospital of Soochow University 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Apr 2016. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area of a special vessel subtype in human bone samples (time frame: 3 months). 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 NCT02750046, which also lists 5 linked publications.
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 25 Apr 2016.