OsteoporosisNCT00689923
Vertebroplasty Using Real-Time, Fluoroscopy-Controlled, Catheter-Assisted, Low-Viscosity Cement Injection
An observational study of Osteoporosis and Compression Fracture, run by National Taiwan University Hospital.
Trial summary
Th low viscosity cement injection is safe in vertebroplasty procedure with Comparacle out come in pain relief. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoporosis, Compression Fracture
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Oct 2008
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: painful vertebral compression fracture
Who may be able to join
- all painful fracture that can not be relieved by pain killer.
Who cannot join
- infection and malignancy in local region
About this study
Th low viscosity cement injection is safe in vertebroplasty procedure with Comparacle out come in pain relief.
Read the detailed description
Pain relief; Comparatle
Cement Leakage; Comparacle
Irradiation dose：less
- Conditions
- Osteoporosis, Compression Fracture
- Medical subject headings
- Osteoporosis, Fractures, Compression
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief
Measured: immediately after procedure
Secondary outcomes (1)
cement leak
Measured: immediate after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startNov 2007
- Primary completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689923
- Sponsor's protocol ID
- 200710029R
- Other IDs
- 200710029R
- Status last verified
- May 2008
- First submitted
- 1 Jun 2008
- Last updated
- 4 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vertebroplasty Using Real-Time, Fluoroscopy-Controlled, Catheter-Assisted, Low-Viscosity Cement Injection
- ClinicalTrials.gov ID
- NCT00689923
- Acronym / sponsor ID
- 200710029R
- Conditions
- Osteoporosis, Compression Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Oct 2008 (estimated)
- First posted
- 4 Jun 2008 (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.
Th low viscosity cement injection is safe in vertebroplasty procedure with Comparacle out come in pain relief.
Detailed description
Pain relief; Comparatle
Cement Leakage; Comparacle
Irradiation dose：less
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- painful vertebral compression fracture
Key inclusion criteria (1 listed)
- all painful fracture that can not be relieved by pain killer.
Key exclusion criteria (1 listed)
- infection and malignancy in local region
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
pain relief
Time frame: immediately after procedure
1 secondary outcome
cement leak
Time frame: immediate after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Compression Fracture, run by National Taiwan University Hospital.
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 4 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain relief (time frame: immediately after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2008.