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

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ClinicalTrials.gov Identifier: NCT03428672
Recruitment Status : Not yet recruiting
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
You-Jia Xu, Second Affiliated Hospital of Soochow University

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.


Condition or disease Intervention/treatment Phase
Femoral Neck Fractures Procedure: total hip arthroplasty Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Collection of Bone Specimens for Quantitative Analysis of Global Proteome and Iron Content Detection
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: osteoporotic fractures
patients with osteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.
Procedure: total hip arthroplasty
Bone samples from Hip fracture were collected from the femoral head which has been replaced

Sham Comparator: nonosteoporotic fractures
patients with nonosteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.
Procedure: total hip arthroplasty
Bone samples from Hip fracture were collected from the femoral head which has been replaced




Primary Outcome Measures :
  1. the iron content in human bone samples [ Time Frame: 3 month ]
    Bone samples were preprocess and decomposed by microwave.Icp-ms is used for quantitative detection of samples.


Secondary Outcome Measures :
  1. The value of bone mineral density [ Time Frame: one week ]
    Bone mineral density was measured by double energy X-ray absorptiometer (DXA) in a week before surgery.

  2. Quantitative Analysis of Global Proteome in bone samples [ Time Frame: 5 month ]
    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.



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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428672


Contacts
Contact: Youjia Xu, PhD 86-0512-67783346 xuyoujia@suda.edu.cn
Contact: Fan Yang, MSc 86-0512-67784115 1066276684@qq.com

Locations
China, Jiagnsu
Second Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiagnsu, China, 215004
Contact: Youjia Xu, PhD    86-0512-67783346    xuyoujia@suda.edu.cn   
Contact: Fan Yang, MSc    86-0512-67784115    1066276684@qq.com   
Sponsors and Collaborators
Second Affiliated Hospital of Soochow University
Investigators
Study Chair: Youjia Xu, PhD Second Affiliated Hospital of Soochow University

Publications of Results:
Responsible Party: You-Jia Xu, Director, Second Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT03428672     History of Changes
Other Study ID Numbers: Xu youjia 003
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries