Clinical trial NCT02750046: Study of A Special Vessel Subtype in Bone Samples From Patients With Osteoporotic and Nonosteoporotic Fracture
Official title: Collection of Bone Specimens for Testing of A Special Vessel Subtype
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: 2016-04-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: The area of a special vessel subtype in human bone samples
timeFrame: 3 months
Secondary outcomes:
measure: The value of bone mineral density
timeFrame: 1 week
measure: Correlation of of bone mineral density and area of a special vessel subtype in human bone
timeFrame: 2 months
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Second Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: Second Affiliated Hospital of Soochow University
name: Youjia Xu, PhD. M.D.
role: STUDY_CHAIR
References:
citation: Kusumbe AP, Ramasamy SK, Adams RH. Coupling of angiogenesis and osteogenesis by a specific vessel subtype in bone. Nature. 2014 Mar 20;507(7492):323-328. doi: 10.1038/nature13145. Epub 2014 Mar 12.
citation: Xie H, Cui Z, Wang L, Xia Z, Hu Y, Xian L, Li C, Xie L, Crane J, Wan M, Zhen G, Bian Q, Yu B, Chang W, Qiu T, Pickarski M, Duong LT, Windle JJ, Luo X, Liao E, Cao X. PDGF-BB secreted by preosteoclasts induces angiogenesis during coupling with osteogenesis. Nat Med. 2014 Nov;20(11):1270-8. doi: 10.1038/nm.3668. Epub 2014 Oct 5.
citation: Ramasamy SK, Kusumbe AP, Wang L, Adams RH. Endothelial Notch activity promotes angiogenesis and osteogenesis in bone. Nature. 2014 Mar 20;507(7492):376-380. doi: 10.1038/nature13146. Epub 2014 Mar 12.
citation: Kusumbe AP, Adams RH. Osteoclast progenitors promote bone vascularization and osteogenesis. Nat Med. 2014 Nov;20(11):1238-40. doi: 10.1038/nm.3747. No abstract available.
citation: Wang L, Zhou F, Zhang P, Wang H, Qu Z, Jia P, Yao Z, Shen G, Li G, Zhao G, Li J, Mao Y, Xie Z, Xu W, Xu Y, Xu Y. Human type H vessels are a sensitive biomarker of bone mass. Cell Death Dis. 2017 May 4;8(5):e2760. doi: 10.1038/cddis.2017.36.