Study of A Special Vessel Subtype in Bone Samples From Patients With Osteoporotic and Nonosteoporotic Fracture

Not Applicable

• Conditions: Femoral Neck Fractures

• Registration Number: NCT02750046
• Lead Sponsor: Second Affiliated Hospital of Soochow University

Brief Summary

RATIONALE: Collecting and storing bone samples from patients with osteoporotic and nonosteoporotic fracture to study a special vessel subtype in the laboratory may help surgeon learn more about the relationship between bone mineral density (BMD) and a special vessel subtype (type H vessel).

PURPOSE: This research study is looking at changes of a special vessel subtype in bone samples from patients with osteoporotic and nonosteoporotic fracture.

Detailed Description

OBJECTIVES:

1. Establish type H vessel in bone specimen in patients with hip fracture.

2. Explore the correlation of BMD and type H vessel.

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. Observe the type H vessel in bone slice by immunofluorescence staining.

4. Collect clinical data on these patients including bone mineral density.

5. Investigate the relationship between BMD and type H vessel.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-24
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-20
• Last Update Submitted: 2016-04-20
• Study First Posted: 2016-04-25
• Last Update Posted: 2016-04-25
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Ages Eligible for Study: 65-75 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 area of a special vessel subtype in human bone samples	3 months	Bone samples were fixed in 4% PFA, decalcified, dehydrated, embedded and immunofluorescent staining for 3 months. Calculate the proportion of the special vessel of total vessel.

Secondary Outcome Measures

Name	Time	Method
The value of bone mineral density	1 week	Bone mineral density was measured by double energy X-ray absorptiometer (DXA) in a week before surgery.
Correlation of of bone mineral density and area of a special vessel subtype in human bone	2 months	Calculate correlation coefficient of BMD and type H vessel in human bone samples in 2 months.

Trial Locations

Locations (1)

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