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

Not Applicable

• Conditions: Femoral Neck Fractures

• Registration Number: NCT03428672
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-01-31
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-09
• Last Update Submitted: 2018-02-09
• Study First Posted: 2018-02-12
• Last Update Posted: 2018-02-12
• Study Start: 2018-04-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the iron content in human bone samples	3 month	Bone samples were preprocess and decomposed by microwave.Icp-ms is used for quantitative detection of samples.

Secondary Outcome Measures

Name	Time	Method
The value of bone mineral density	one week	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	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.

Trial Locations

Locations (1)

Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiagnsu, China