OsteoporosisNCT01653873
Imaging Parameters to Predict Future Vertebral Fracture in Osteoporosis
An observational study of Osteoporosis and Fracture, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoporosis, Fracture
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2012to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all the patients received vertebroplasty treatment between 2005.01-2011.12
Who may be able to join
- All the patients received vertebroplasty treatment between 2005.01-2011.12 with 2nd fracture in the vertebral column.
Who cannot join
- No image available
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 10016
Hon-Man Liu, MD, MBA, 886-2-23123456 ext. 70329, hmliu@ntu.edu.tw
Hon-Man Liu, MD, MBA
About this study
Official title: to Compare the Efficacy of Parameters From Different Imaging Modality in Predicting the Risk of Future Vertebral Compression Fracture in Osteoporotic Patients.
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.
Read the 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.
- Conditions
- Osteoporosis, Fracture
- Keywords
- fracture, vertebral column, osteoporosis, predictor, vertebroplasty
- Medical subject headings
- Osteoporosis, Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
fracture
2nd fracture within 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Hon-Man Liu, MD, MBA, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653873
- Sponsor's protocol ID
- 201202077RIC
- Status last verified
- Jan 2014
- First submitted
- 27 Jul 2012
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16160740
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- to Compare the Efficacy of Parameters From Different Imaging Modality in Predicting the Risk of Future Vertebral Compression Fracture in Osteoporotic Patients.
- ClinicalTrials.gov ID
- NCT01653873
- Acronym / sponsor ID
- 201202077RIC
- Conditions
- Osteoporosis, Fracture
- Keywords
- fracture, vertebral column, osteoporosis, predictor, vertebroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all the patients received vertebroplasty treatment between 2005.01-2011.12
Key inclusion criteria (1 listed)
- All the patients received vertebroplasty treatment between 2005.01-2011.12 with 2nd fracture in the vertebral column.
Key exclusion criteria (1 listed)
- No image available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fracture
Time frame: 5 years
2nd fracture within 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
- Background: PubMed 16160740Ito 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hon-Man Liu, MD, MBA principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Fracture, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hon-man Liu, MD, MBA (886-2-23123456 ext. 70329, hmliu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fracture (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01653873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2014.