NCT01653873

Brief Summary

After vertebroplasty, many patients will suffer from 2nd fracture in the vertebral column. With analyzing of the images done right after the 1st vertebroplasty, we can define the parameters from different imaging and they can be predictors of the future 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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

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

July 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 24, 2014

Status Verified

January 1, 2014

Enrollment Period

4.4 years

First QC Date

July 27, 2012

Last Update Submit

January 23, 2014

Conditions

OsteoporosisFracture

Keywords

fracturevertebral columnosteoporosispredictorvertebroplasty

Outcome Measures

Primary Outcomes (1)

  • fracture

    2nd fracture within 5 years

    5 years

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all the patients received vertebroplasty treatment between 2005.01-2011.12

You may qualify if:

  • All the patients received vertebroplasty treatment between 2005.01-2011.12 with 2nd fracture in the vertebral column.

You may not qualify if:

  • No image available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 10016, Taiwan

RECRUITING

Related Publications (1)

  • Ito M, Ikeda K, Nishiguchi M, Shindo H, Uetani M, Hosoi T, Orimo H. Multi-detector row CT imaging of vertebral microstructure for evaluation of fracture risk. J Bone Miner Res. 2005 Oct;20(10):1828-36. doi: 10.1359/JBMR.050610. Epub 2005 Jun 20.

    PMID: 16160740BACKGROUND

MeSH Terms

Conditions

OsteoporosisFractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and Injuries

Study Officials

  • Hon-Man Liu, MD, MBA

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hon-man Liu, MD, MBA

CONTACT

886-2-23123456hmliu@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman

Study Record Dates

First Submitted

July 27, 2012

First Posted

July 31, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

January 24, 2014

Record last verified: 2014-01

Locations

TW(1)