NCT02750046

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

1.9 years

First QC Date

March 24, 2016

Last Update Submit

April 20, 2016

Conditions

Femoral Neck Fractures

Outcome Measures

Primary Outcomes (1)

  • The area of a special vessel subtype in human bone samples

    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.

    3 months

Secondary Outcomes (2)

  • The value of bone mineral density

    1 week

  • Correlation of of bone mineral density and area of a special vessel subtype in human bone

    2 months

Study Arms (2)

osteoporotic fractures

EXPERIMENTAL

patients with osteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.

Procedure: total hip arthroplasty or proximal femoral nails

nonosteoporotic fractures

SHAM COMPARATOR

patients with nonosteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.

Procedure: total hip arthroplasty or proximal femoral nails

Interventions

total hip arthroplasty or proximal femoral nailsPROCEDURE

Bone samples from Hip fracture were collected when total hip arthroplasty or proximal femoral nails was performed.

nonosteoporotic fracturesosteoporotic fractures

Eligibility Criteria

Age60 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages Eligible for Study: 65-75 Years
  • Genders Eligible for Study: Woman
  • Accepts Healthy Volunteers: NO
  • Study Population: Female patients with hip fracture. -

You may not qualify if:

  • Malignancy or benign ovarian cysts
  • Known chronic or systemic diseases
  • Hormone therapy in the previous 3 months
  • Bone metabolism and drug therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

Related Publications (5)

  • 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.

    PMID: 24646994RESULT

  • 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.

    PMID: 25282358RESULT

  • 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.

    PMID: 24647000RESULT

  • 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.

    PMID: 25375923RESULT

  • 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.

    PMID: 28471445DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Youjia Xu, PhD. M.D.

    Second Affiliated Hospital of Soochow University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2016

First Posted

April 25, 2016

Study Start

March 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

April 25, 2016

Record last verified: 2016-04

Locations

CN(1)