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Imaging Parameters to Predict Future Vertebral Fracture in Osteoporosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01653873
First Posted: July 31, 2012
Last Update Posted: January 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 27, 2012
First Posted: July 31, 2012
Last Update Posted: January 24, 2014
Last Verified: January 2014

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

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