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Study of A Special Vessel Subtype in Bone Samples From Patients With Osteoporotic and Nonosteoporotic Fracture

Primary Purpose

Femoral Neck Fractures

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
total hip arthroplasty or proximal femoral nails
Sponsored by
Second Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Femoral Neck Fractures

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Ages Eligible for Study: 65-75 Years
  2. Genders Eligible for Study: Woman
  3. Accepts Healthy Volunteers: NO
  4. Study Population: Female patients with hip fracture. -

Exclusion Criteria:

  1. Malignancy or benign ovarian cysts
  2. Known chronic or systemic diseases
  3. Hormone therapy in the previous 3 months
  4. Bone metabolism and drug therapy

Sites / Locations

  • Second Affiliated Hospital of Soochow University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

osteoporotic fractures

nonosteoporotic fractures

Arm Description

patients with osteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.

patients with nonosteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The value of bone mineral density
Bone mineral density was measured by double energy X-ray absorptiometer (DXA) in a week before surgery.
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.

Full Information

First Posted
March 24, 2016
Last Updated
April 20, 2016
Sponsor
Second Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT02750046
Brief Title
Study of A Special Vessel Subtype in Bone Samples From Patients With Osteoporotic and Nonosteoporotic Fracture
Official Title
Collection of Bone Specimens for Testing of A Special Vessel Subtype
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Soochow University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
osteoporotic fractures
Arm Type
Experimental
Arm Description
patients with osteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.
Arm Title
nonosteoporotic fractures
Arm Type
Sham Comparator
Arm Description
patients with nonosteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.
Intervention Type
Procedure
Intervention Name(s)
total hip arthroplasty or proximal femoral nails
Intervention Description
Bone samples from Hip fracture were collected when total hip arthroplasty or proximal femoral nails was performed.
Primary Outcome Measure Information:
Title
The area of a special vessel subtype in human bone samples
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The value of bone mineral density
Description
Bone mineral density was measured by double energy X-ray absorptiometer (DXA) in a week before surgery.
Time Frame
1 week
Title
Correlation of of bone mineral density and area of a special vessel subtype in human bone
Description
Calculate correlation coefficient of BMD and type H vessel in human bone samples in 2 months.
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages Eligible for Study: 65-75 Years Genders Eligible for Study: Woman Accepts Healthy Volunteers: NO Study Population: Female patients with hip fracture. - Exclusion Criteria: Malignancy or benign ovarian cysts Known chronic or systemic diseases Hormone therapy in the previous 3 months Bone metabolism and drug therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youjia Xu, PhD. M.D.
Organizational Affiliation
Second Affiliated Hospital of Soochow University
Official's Role
Study Chair
Facility Information:
Facility Name
Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24646994
Citation
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. Erratum In: Nature. 2014 Sep 25;513(7519):574.
Results Reference
result
PubMed Identifier
25282358
Citation
Xie 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 Reference
result
PubMed Identifier
24647000
Citation
Ramasamy 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 Reference
result
PubMed Identifier
25375923
Citation
Kusumbe 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.
Results Reference
result
PubMed Identifier
28471445
Citation
Wang 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.
Results Reference
derived

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Study of A Special Vessel Subtype in Bone Samples From Patients With Osteoporotic and Nonosteoporotic Fracture

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