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

NCT ID: NCT03428672

Last Updated: 2018-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-05-01

Brief Summary

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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

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OBJECTIVES:

1. Establish the iron content in bone specimen in patients with hip fracture.
2. Explore the correlation of BMD and differentially expressed proteins.

OUTLINE:

1. Collect human bone specimens from patients with osteoporotic and nonosteoporotic Fracture.
2. Provide a repository for storage of tissue and make these specimens available for approved projects by laboratory-based investigators.
3. Collect clinical data on these patients including bone mineral density.
4. To examine the bone iron content using ICP/MS.
5. Investigate the differentially expressed proteins through quantitative analysing the global proteome of osteoporotic and nonosteoporotic fracture bone specimens.

Conditions

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Femoral Neck Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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osteoporotic fractures

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

Group Type EXPERIMENTAL

total hip arthroplasty

Intervention Type PROCEDURE

Bone samples from Hip fracture were collected from the femoral head which has been replaced

nonosteoporotic fractures

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

Group Type SHAM_COMPARATOR

total hip arthroplasty

Intervention Type PROCEDURE

Bone samples from Hip fracture were collected from the femoral head which has been replaced

Interventions

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total hip arthroplasty

Bone samples from Hip fracture were collected from the femoral head which has been replaced

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

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You-Jia Xu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Youjia Xu, PhD

Role: STUDY_CHAIR

Second Affiliated Hospital of Soochow University

Locations

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Second Affiliated Hospital of Soochow University

Suzhou, Jiagnsu, China

Site Status

Countries

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China

Central Contacts

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Youjia Xu, PhD

Role: CONTACT

86-0512-67783346

Fan Yang, MSc

Role: CONTACT

86-0512-67784115

Facility Contacts

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Youjia Xu, PhD

Role: primary

86-0512-67783346

Fan Yang, MSc

Role: backup

86-0512-67784115

References

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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.

Reference Type RESULT
PMID: 28007936 (View on PubMed)

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.

Reference Type RESULT
PMID: 28854368 (View on PubMed)

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.

Reference Type RESULT
PMID: 28578906 (View on PubMed)

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.

Reference Type RESULT
PMID: 10898394 (View on PubMed)

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.

Reference Type RESULT
PMID: 23415599 (View on PubMed)

Other Identifiers

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Xu youjia 003

Identifier Type: -

Identifier Source: org_study_id

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