Imaging Parameters to Predict Future Vertebral Fracture in Osteoporosis

Osteoporosis Clinical Trial

Official title:

to Compare the Efficacy of Parameters From Different Imaging Modality in Predicting the Risk of Future Vertebral Compression Fracture in Osteoporotic Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01653873
• Other study ID #: 201202077RIC
• Status: Recruiting
• Phase: N/A
• First received: July 27, 2012
• Last updated: January 23, 2014
• Start date: July 2012
• Est. completion date: December 2017

Study information

• Verified date: January 2014
• Source: National Taiwan University Hospital
• Contact: Hon-man Liu, MD, MBA
• Phone: 886-2-23123456
• Email: hmliu[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone
• Osteoporosis

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & 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. Epub 2005 Jun 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fracture	2nd fracture within 5 years	5 years	No