OsteoporosisNCT00635297
Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra
A study testing Percutaneous vertebroplasty in people with Osteoporosis and Vertebral Fracture, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
Percutaneous vertebroplasty is a treatment for painful osteoporotic compression fractures. Multiple reports have shown as high as 20 % refracturerates in vertebrae adjacent to those that have been treated with percutaneous vertebroplasty. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis, Vertebral Fracture
- What is being tested?
- Percutaneous vertebroplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2008to Apr 2009
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CT and MRI proven non healed painful osteoporotic compression fracture in the thoracic and lumbar spine.
Who cannot join
- Infection
- High grade spinal stenosis
- Contraindications to MRI
- Dementia
Trial locations and contacts
1 site in 1 country.
Norway1 site
Nevroradiologisk avdeling Ullevål universitetssykehus HF
Oslo, Oslo, 0407
About this study
Official title: Percutaneous Vertebroplasty.Study of Refracture Rates After Prophylactic Vertebroplasty of Adjacent Vertebrae
Percutaneous vertebroplasty is a treatment for painful osteoporotic compression fractures. Multiple reports have shown as high as 20 % refracturerates in vertebrae adjacent to those that have been treated with percutaneous vertebroplasty.
The purpose of the study is to determine if prophylactic vertebroplasty of unfractured vertebrae adjacent to the treated fractured vertebrae can reduce the rates of refracture in adjacent vertebrae.
- Conditions
- Osteoporosis, Vertebral Fracture
- Being tested
- Percutaneous vertebroplasty
- Keywords
- osteoporosis, vertebroplasty, prophylactic, vertebrae, fracture
- Medical subject headings
- Osteoporosis, Spinal Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous vertebroplastyProcedure or surgery
Also called PMMA
PMMA injection 3-10 milliliter in each treated vertebrae
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 50 osteoporotic patients with a vertebral insufficiency fracture will receive treatment of the vertebrae with standard vertebroplasty Receives: Procedure: Percutaneous vertebroplasty |
| 2 | Experimental | 50 osteoporotic patients with a vertebral insufficiency fracture will receive treatment of the vertebrae with standard vertebroplasty. The adjacent vertebrae will be treated with 3-5 ml of PMMA Receives: Procedure: Percutaneous vertebroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refracture rate based on MRI and CT after 3 months and one year
Measured: 3 months and one year
Secondary outcomes (1)
Pain relief after the procedure based on VAS
Measured: 3 months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009 (estimated)
- Study completionApr 2009 (estimated)
Why it stopped: Problems with patient recruitement
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.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Per Hj Nakstad, Phd, Study director, Nevroradiologisk avdeling Ullevål Universitetssykehus HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635297
- Sponsor's protocol ID
- 889 VP
- Status last verified
- Jan 2008
- First submitted
- 5 Mar 2008
- Last updated
- 3 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Vertebroplasty.Study of Refracture Rates After Prophylactic Vertebroplasty of Adjacent Vertebrae
- ClinicalTrials.gov ID
- NCT00635297
- Acronym / sponsor ID
- 889 VP
- Conditions
- Osteoporosis, Vertebral Fracture
- Keywords
- osteoporosis, vertebroplasty, prophylactic, vertebrae, fracture
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Problems with patient recruitement
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Apr 2009 (estimated)
- First posted
- 13 Mar 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.
Percutaneous vertebroplasty is a treatment for painful osteoporotic compression fractures. Multiple reports have shown as high as 20 % refracturerates in vertebrae adjacent to those that have been treated with percutaneous vertebroplasty.
The purpose of the study is to determine if prophylactic vertebroplasty of unfractured vertebrae adjacent to the treated fractured vertebrae can reduce the rates of refracture in adjacent vertebrae.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Percutaneous vertebroplasty50 osteoporotic patients with a vertebral insufficiency fracture will receive treatment of the vertebrae with standard vertebroplasty |
| 2 | Experimental | Procedure: Percutaneous vertebroplasty50 osteoporotic patients with a vertebral insufficiency fracture will receive treatment of the vertebrae with standard vertebroplasty. The adjacent vertebrae will be treated with 3-5 ml of PMMA |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CT and MRI proven non healed painful osteoporotic compression fracture in the thoracic and lumbar spine.
Key exclusion criteria (4 listed)
- Infection
- High grade spinal stenosis
- Contraindications to MRI
- Dementia
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 vertebroplastyAlso: PMMAPMMA injection 3-10 milliliter in each treated vertebrae | Procedure or surgery | 1, 2 |
Primary outcome
Refracture rate based on MRI and CT after 3 months and one year
Time frame: 3 months and one year
1 secondary outcome
Pain relief after the procedure based on VAS
Time frame: 3 months and one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2010.
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
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.
Per Hj Nakstad, Phd study director
Nevroradiologisk avdeling Ullevål Universitetssykehus HF
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 vertebroplasty in people with Osteoporosis and Vertebral Fracture, run by Ullevaal University Hospital at 1 site in Norway.
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 4 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: paused, as of the sponsor's last update on 3 Mar 2010. 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 Norway. 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?
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?
Refracture rate based on MRI and CT after 3 months and one year (time frame: 3 months and one year). 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 3 Mar 2010.