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

Femoral Neck Fractures Clinical Trial

Official title:

Collection of Bone Specimens for Quantitative Analysis of Global Proteome and Iron Content Detection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03428672
• Other study ID #: Xu youjia 003
• Status: Not yet recruiting
• Phase: N/A
• First received: January 31, 2018
• Last updated: February 9, 2018
• Start date: April 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: February 2018
• Source: Second Affiliated Hospital of Soochow University
• Contact: Youjia Xu, PhD
• Phone: 86-0512-67783346
• Email: xuyoujia[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone

Intervention

Procedure:
• total hip arthroplasty
Bone samples from Hip fracture were collected from the femoral head which has been replaced

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Soochow University	Suzhou	Jiagnsu

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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 — View 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. — View Citation

Roumeliotis TI, Williams SP, Gonçalves 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-R — View 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 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the iron content in human bone samples	Bone samples were preprocess and decomposed by microwave.Icp-ms is used for quantitative detection of samples.	3 month
Secondary	The value of bone mineral density	Bone mineral density was measured by double energy X-ray absorptiometer (DXA) in a week before surgery.	one week
Secondary	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.	5 month