Spinal FractureNCT00994032
Quality of Life After Vertebroplasty Versus Conservative Treatment in Patients With Painful Osteoporotic Vertebral Fractures
A study testing percutaneous injection of cement into the vertebral body and Medical treatment in people with Spinal Fracture and Osteoporosis, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether percutaneous vertebroplasty is able to improve long-term quality of life in patients with pain secondary to osteoporotic vertebral fractures, compared to conventional medical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Fracture, Osteoporosis, Back Pain
- What is being tested?
- percutaneous injection of cement into the vertebral body and Medical treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2006to 1 Jun 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Painful (pain intensity of at least 4 on a scale from 0 to 10) osteoporotic vertebral fracture between levels T4 and L5
- Fragility; i.e. fracture not in relation with significant trauma
- Recent fracture, pain beginning not earlier than 1 year before inclusion
Who cannot join
- No vertebral edema on STIR MR images
- Uncorrectable bleeding diatheses
- Active infection
- Substantial retropulsion of bony fragments
- Non-osteoporotic fracture
- Concomitant neoplasm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Impact in the Quality of Life of Patients With Pain Secondary to Osteoporotic Vertebral Fractures Receiving Conservative Treatment Versus Percutaneous Vertebroplasty
The purpose of this study is to determine whether percutaneous vertebroplasty is able to improve long-term quality of life in patients with pain secondary to osteoporotic vertebral fractures, compared to conventional medical treatment.
Read the detailed description
Osteoporotic vertebral fractures are associated with pain and severe disability in a high percentage of patients. Vertebroplasty has become the treatment of choice to alleviate pain in those patients who have not responded to medical treatment.Although several case series and non-randomized studies have shown the effectiveness of vertebroplasty in alleviating pain secondary to osteoporotic vertebral fractures, the long-term effect of this treatment has not been compared to standard medical treatment in a randomized study.
In our study we have analyzed the long-term effect of vertebroplasty in terms of quality of life in patients with painful osteoporotic vertebral fractures, randomizing them into two arms: percutaneous vertebroplasty or conventional medical treatment.
- Conditions
- Spinal Fracture, Osteoporosis, Back Pain
- Being tested
- percutaneous injection of cement into the vertebral body, Medical treatment
- Keywords
- vertebroplasty, disability evaluation, outcome assessment, pain measurement
- Medical subject headings
- Spinal Fractures, Osteoporosis, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous injection of cement into the vertebral bodyProcedure or surgery
percutaneous injection of cement into the vertebral body
Medical treatmentOther
standard antalgic medical treatment
| Study group | Role | What they receive |
|---|---|---|
| vertebroplasty | Active comparator | Not described Receives: Procedure: percutaneous injection of cement into the vertebral body |
| Medical Treatment | Active comparator | Not described Receives: Other: Medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact into quality of life with the Qualeffo-41 test
Measured: Baseline, 2 weeks, 2 months, 6 months and 1 year
Secondary outcomes (1)
Analyze pain alleviation with the Analog Visual Scale
Measured: Baseline, 2 weeks, 2 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startMar 2006
- Primary completion1 Jun 2011
- Study completion1 Jun 2011
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 Spinal FractureStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Española de Radiologia Medica
- Responsible party
- Principal investigator, JORDI BLASCO ANDALUZ, Hospital Clinic of Barcelona
- Investigators
- Jordi Blasco, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994032
- Sponsor's protocol ID
- HCPB-VP
- Status last verified
- Feb 2017
- First submitted
- 13 Oct 2009
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Blasco J, Martinez-Ferrer A, Macho J, San Roman L, Pomes J, Carrasco J, Monegal A, Guanabens N, Peris P. Effect of vertebroplasty on pain relief, quality of life, and the incidence of new vertebral fractures: a 12-month randomized follow-up, controlled trial. J Bone Miner Res. 2012 May;27(5):1159-66. doi: 10.1002/jbmr.1564.
PubMed 22513649
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Impact in the Quality of Life of Patients With Pain Secondary to Osteoporotic Vertebral Fractures Receiving Conservative Treatment Versus Percutaneous Vertebroplasty
- ClinicalTrials.gov ID
- NCT00994032
- Acronym / sponsor ID
- HCPB-VP
- Conditions
- Spinal Fracture, Osteoporosis, Back Pain
- Keywords
- vertebroplasty, disability evaluation, outcome assessment, pain measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Sociedad Española de Radiologia Medica
- Study start
- Mar 2006
- Primary completion
- 1 Jun 2011 (actual)
- Study completion
- 1 Jun 2011 (actual)
- First posted
- 14 Oct 2009 (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.
The purpose of this study is to determine whether percutaneous vertebroplasty is able to improve long-term quality of life in patients with pain secondary to osteoporotic vertebral fractures, compared to conventional medical treatment.
Detailed description
Osteoporotic vertebral fractures are associated with pain and severe disability in a high percentage of patients. Vertebroplasty has become the treatment of choice to alleviate pain in those patients who have not responded to medical treatment.Although several case series and non-randomized studies have shown the effectiveness of vertebroplasty in alleviating pain secondary to osteoporotic vertebral fractures, the long-term effect of this treatment has not been compared to standard medical treatment in a randomized study.
In our study we have analyzed the long-term effect of vertebroplasty in terms of quality of life in patients with painful osteoporotic vertebral fractures, randomizing them into two arms: percutaneous vertebroplasty or conventional medical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vertebroplasty | Active comparator | Procedure: percutaneous injection of cement into the vertebral body |
| Medical Treatment | Active comparator | Other: Medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Painful (pain intensity of at least 4 on a scale from 0 to 10) osteoporotic vertebral fracture between levels T4 and L5
- Fragility; i.e. fracture not in relation with significant trauma
- Recent fracture, pain beginning not earlier than 1 year before inclusion
Key exclusion criteria (6 listed)
- No vertebral edema on STIR MR images
- Uncorrectable bleeding diatheses
- Active infection
- Substantial retropulsion of bony fragments
- Non-osteoporotic fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous injection of cement into the vertebral bodypercutaneous injection of cement into the vertebral body | Procedure or surgery | vertebroplasty |
| Medical treatmentstandard antalgic medical treatment | Other | Medical Treatment |
Primary outcome
Impact into quality of life with the Qualeffo-41 test
Time frame: Baseline, 2 weeks, 2 months, 6 months and 1 year
1 secondary outcome
Analyze pain alleviation with the Analog Visual Scale
Time frame: Baseline, 2 weeks, 2 months, 6 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 22513649Blasco J, Martinez-Ferrer A, Macho J, San Roman L, Pomes J, Carrasco J, Monegal A, Guanabens N, Peris P. Effect of vertebroplasty on pain relief, quality of life, and the incidence of new vertebral fractures: a 12-month randomized follow-up, controlled trial. J Bone Miner Res. 2012 May;27(5):1159-66. doi: 10.1002/jbmr.1564.
- International Osteoporosis FoundationLink provided by the sponsor.
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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.
Jordi Blasco, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous injection of cement into the vertebral body and Medical treatment in people with Spinal Fracture and Osteoporosis, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 23 Feb 2017. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Impact into quality of life with the Qualeffo-41 test (time frame: Baseline, 2 weeks, 2 months, 6 months and 1 year). 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 NCT00994032, 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 23 Feb 2017.