NCT03428672

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.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

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

First Submitted

Initial submission to the registry

January 31, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

9 months

First QC Date

January 31, 2018

Last Update Submit

February 9, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • the iron content in human bone samples

    Bone samples were preprocess and decomposed by microwave.Icp-ms is used for quantitative detection of samples.

    3 month

Secondary Outcomes (2)

  • The value of bone mineral density

    one week

  • Quantitative Analysis of Global Proteome in bone samples

    5 month

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

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

Interventions

Bone samples from Hip fracture were collected from the femoral head which has been replaced

nonosteoporotic fracturesosteoporotic fractures

Eligibility Criteria

Age55 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages Eligible for Study: 55-90 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, Jiagnsu, 215004, China

Location

Related Publications (5)

  • Geyer PE, Wewer Albrechtsen NJ, Tyanova S, Grassl N, Iepsen EW, Lundgren J, Madsbad S, Holst JJ, Torekov SS, Mann M. Proteomics reveals the effects of sustained weight loss on the human plasma proteome. Mol Syst Biol. 2016 Dec 22;12(12):901. doi: 10.15252/msb.20167357.

  • Roumeliotis TI, Williams SP, Goncalves E, Alsinet C, Del Castillo Velasco-Herrera M, Aben N, Ghavidel FZ, Michaut M, Schubert M, Price S, Wright JC, Yu L, Yang M, Dienstmann R, Guinney J, Beltrao P, Brazma A, Pardo M, Stegle O, Adams DJ, Wessels L, Saez-Rodriguez J, McDermott U, Choudhary JS. Genomic Determinants of Protein Abundance Variation in Colorectal Cancer Cells. Cell Rep. 2017 Aug 29;20(9):2201-2214. doi: 10.1016/j.celrep.2017.08.010.

  • Zeng Y, Zhang L, Zhu W, Xu C, He H, Zhou Y, Liu YZ, Tian Q, Zhang JG, Deng FY, Hu HG, Zhang LS, Deng HW. Corrigendum to "Quantitative proteomics and integrative network analysis identified novel genes and pathways related to osteoporosis" [J. Proteomics 142 (16 June 2016) 45-52]. J Proteomics. 2017 Jun 6;162:155. doi: 10.1016/j.jprot.2017.05.023. No abstract available.

  • Kuo HW, Kuo SM, Chou CH, Lee TC. Determination of 14 elements in Taiwanese bones. Sci Total Environ. 2000 Jun 8;255(1-3):45-54. doi: 10.1016/s0048-9697(00)00448-4.

  • Brodziak-Dopierala B, Kwapulinski J, Sobczyk K, Wiechula D. The content of manganese and iron in hip joint tissue. J Trace Elem Med Biol. 2013 Jul;27(3):208-12. doi: 10.1016/j.jtemb.2012.12.005. Epub 2013 Feb 15.

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

    Second Affiliated Hospital of Soochow University

    STUDY CHAIR

Central Study Contacts

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
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 12, 2018

Study Start

April 1, 2018

Primary Completion

January 1, 2019

Study Completion

May 1, 2019

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations