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Imaging Parameters to Predict Future Vertebral Fracture in Osteoporosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01653873
First received: July 27, 2012
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition
Osteoporosis
Fracture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: to Compare the Efficacy of Parameters From Different Imaging Modality in Predicting the Risk of Future Vertebral Compression Fracture in Osteoporotic Patients.

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • fracture [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    2nd fracture within 5 years


Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Detailed Description:

Vertebroplasty is considered one of the alternatives for the treating of spine compression fracture associated with pain especially for those patients with osteoporosis. However, after vertebroplasty, the compliance of the bone becomes stronger than the adjacent vertebrae that is not treated. So there is always a consideration of future fracture of the adjacent vertebral bodies after vertebroplasty done on certain body. In this study, we try to follow the patients (5 years) to see if the adjacent vertebral bodies are prone to have fracture than the others away from the site of vertebroplasty.Then we try to find out the image biomarkers to predict the future fracture in the vertebral bodies. The should be done with CT scan raw data, analysis with different algorithms.

Inclusion criteria; patients with osteoporosis and receiving vertebroplasty and with secondary fracture occurring in other spine exclusion criteria: No second vertebral body fracture occurred. Primary measurement: the time and location of the 2nd fracture secondary measurement: the imaging biomarkers from CT scan.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

all the patients received vertebroplasty treatment between 2005.01-2011.12

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No image available
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653873

Contacts
Contact: Hon-man Liu, MD, MBA 886-2-23123456 ext 70329 hmliu@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10016
Contact: Hon-Man Liu, MD, MBA    886-2-23123456 ext 70329    hmliu@ntu.edu.tw   
Principal Investigator: Hon-Man Liu, MD, MBA         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Hon-Man Liu, MD, MBA National Taiwan University Hospital
  More Information

Publications:
Responsible Party: National Taiwan University Hospital, Chairman
ClinicalTrials.gov Identifier: NCT01653873     History of Changes
Other Study ID Numbers: 201202077RIC
Study First Received: July 27, 2012
Last Updated: January 23, 2014
Health Authority: Taiwan: Research Ethics Committee

Keywords provided by National Taiwan University Hospital:
fracture
vertebral column
osteoporosis
predictor
vertebroplasty

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on November 23, 2014