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Quantitative Analysis of Global Proteome 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
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

55 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Ages Eligible for Study: 55-90 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 iron content in human bone samples
Bone samples were preprocess and decomposed by microwave.Icp-ms is used for quantitative detection of samples.

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.
Quantitative Analysis of Global Proteome in bone samples
Find the differentially expressed proteins in nonosteoporotic or osteoporotic bone sample through using an integrated approach involving TMT labeling and LC-MS/MS to quantify the dynamic changes of the whole proteome of Human Species.

Full Information

First Posted
January 31, 2018
Last Updated
February 9, 2018
Sponsor
Second Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT03428672
Brief Title
Quantitative Analysis of Global Proteome in Bone Samples From Patients With Osteoporotic and Nonosteoporotic Fracture
Official Title
Collection of Bone Specimens for Quantitative Analysis of Global Proteome and Iron Content Detection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Anticipated)
Primary Completion Date
January 1, 2019 (Anticipated)
Study Completion Date
May 1, 2019 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
RATIONALE: Collecting and storing bone samples from patients with osteoporotic and nonosteoporotic fracture to quantitatively analyze the differentially expressed proteins to further explain the relationship between bone iron content and bone mineral density (BMD). PURPOSE: This research study is looking at changes of iron content and differentially expressed proteins in bone samples from patients with osteoporotic and nonosteoporotic. fracture.
Detailed Description
OBJECTIVES: Establish the iron content in bone specimen in patients with hip fracture. Explore the correlation of BMD and differentially expressed proteins. 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. Collect clinical data on these patients including bone mineral density. To examine the bone iron content using ICP/MS. Investigate the differentially expressed proteins through quantitative analysing the global proteome of osteoporotic and nonosteoporotic fracture bone specimens.

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
100 (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
Intervention Description
Bone samples from Hip fracture were collected from the femoral head which has been replaced
Primary Outcome Measure Information:
Title
the iron content in human bone samples
Description
Bone samples were preprocess and decomposed by microwave.Icp-ms is used for quantitative detection of samples.
Time Frame
3 month
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
one week
Title
Quantitative Analysis of Global Proteome in bone samples
Description
Find the differentially expressed proteins in nonosteoporotic or osteoporotic bone sample through using an integrated approach involving TMT labeling and LC-MS/MS to quantify the dynamic changes of the whole proteome of Human Species.
Time Frame
5 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages Eligible for Study: 55-90 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youjia Xu, PhD
Phone
86-0512-67783346
Email
xuyoujia@suda.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Fan Yang, MSc
Phone
86-0512-67784115
Email
1066276684@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youjia Xu, PhD
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
Jiagnsu
ZIP/Postal Code
215004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youjia Xu, PhD
Phone
86-0512-67783346
Email
xuyoujia@suda.edu.cn
First Name & Middle Initial & Last Name & Degree
Fan Yang, MSc
Phone
86-0512-67784115
Email
1066276684@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28007936
Citation
Geyer PE, Wewer Albrechtsen NJ, Tyanova S, Grassl N, Iepsen EW, Lundgren J, Madsbad S, Holst JJ, Torekov SS, Mann M. Proteomics reveals the effects of sustained weight loss on the human plasma proteome. Mol Syst Biol. 2016 Dec 22;12(12):901. doi: 10.15252/msb.20167357.
Results Reference
result
PubMed Identifier
28854368
Citation
Roumeliotis TI, Williams SP, Goncalves E, Alsinet C, Del Castillo Velasco-Herrera M, Aben N, Ghavidel FZ, Michaut M, Schubert M, Price S, Wright JC, Yu L, Yang M, Dienstmann R, Guinney J, Beltrao P, Brazma A, Pardo M, Stegle O, Adams DJ, Wessels L, Saez-Rodriguez J, McDermott U, Choudhary JS. Genomic Determinants of Protein Abundance Variation in Colorectal Cancer Cells. Cell Rep. 2017 Aug 29;20(9):2201-2214. doi: 10.1016/j.celrep.2017.08.010.
Results Reference
result
PubMed Identifier
28578906
Citation
Zeng Y, Zhang L, Zhu W, Xu C, He H, Zhou Y, Liu YZ, Tian Q, Zhang JG, Deng FY, Hu HG, Zhang LS, Deng HW. Corrigendum to "Quantitative proteomics and integrative network analysis identified novel genes and pathways related to osteoporosis" [J. Proteomics 142 (16 June 2016) 45-52]. J Proteomics. 2017 Jun 6;162:155. doi: 10.1016/j.jprot.2017.05.023. No abstract available.
Results Reference
result
PubMed Identifier
10898394
Citation
Kuo HW, Kuo SM, Chou CH, Lee TC. Determination of 14 elements in Taiwanese bones. Sci Total Environ. 2000 Jun 8;255(1-3):45-54. doi: 10.1016/s0048-9697(00)00448-4.
Results Reference
result
PubMed Identifier
23415599
Citation
Brodziak-Dopierala B, Kwapulinski J, Sobczyk K, Wiechula D. The content of manganese and iron in hip joint tissue. J Trace Elem Med Biol. 2013 Jul;27(3):208-12. doi: 10.1016/j.jtemb.2012.12.005. Epub 2013 Feb 15.
Results Reference
result

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Quantitative Analysis of Global Proteome in Bone Samples From Patients With Osteoporotic and Nonosteoporotic Fracture

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