Clinical trial NCT03428672: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Femoral Neck Fractures
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: the iron content in human bone samples
timeFrame: 3 month
Secondary outcomes:
measure: The value of bone mineral density
timeFrame: one week
measure: Quantitative Analysis of Global Proteome in bone samples
timeFrame: 5 month
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Second Affiliated Hospital of Soochow University
state: Jiagnsu
Study officials:
affiliation: Second Affiliated Hospital of Soochow University
name: Youjia Xu, PhD
role: STUDY_CHAIR
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