Osteoporotic Vertebral Compression FracturesVOPE2 COMPASNCT06776003
Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture
A study testing Vertebroplasty in people with Osteoporotic Vertebral Compression Fractures, run by Spine Centre of Southern Denmark at 1 site in Denmark.
Trial summary
The aim of this clinical trial is to determine if vertebroplasty is an effective treatment for acute, painful vertebral fractures due to osteoporosis. The focus of the study is on the physical activity and mobility of participants. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporotic Vertebral Compression Fractures
- What is being tested?
- Vertebroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Feb 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients aged 50+ and diagnosed with symptomatic osteoporotic spinal compression fractures between T6 and L5 (incl).
- Focal tenderness on the level of the vertebral fracture.
- Fractures verified with oedema of the relevant vertebra on the MRI STIR sequence.
- Osteoporotic Fractures type 1-4.
- Fracture involves no more than 4 vertebral body levels.
- Vertebroplasty can be done in one session.
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- Back pain score measured on a Visual Analog Scale (VAS, 0 to 100) ≥ 60.
- Able to understand and read Danish.
- Written informed consent.
- Relevant pain started ≤ 3 months prior to enrollment.
Who cannot join
- Contra-indications for spine surgery.
- Platelets < 30 mia/l.
- Osteoporotic Fractures type 5 and Pincer-type.
- Complete collapse of the vertebral body precluding insertion of needle.
- Presence of neurologic deficit.
- Contraindications for MRI scanning.
Show all 11Show fewer
- Psychological or psychiatric disorder that is expected to interfere with compliance.
- Active malignancy.
- Mini Mental State Examination (MMSE) test score below 24.
- History of chronic back pain requiring ongoing opiate use.
- Systemic or local infection of the spine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Spine Centre of Southern Denmark
Kolding, 6000
Søren W Sørensen, MD, 0045 76 36 20 00, soren.wittorff.sorensen@rsyd.dk
About this study
Official title: Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture: a Single-center, Double-blind Randomized Controlled Clinical Trial
The aim of this clinical trial is to determine if vertebroplasty is an effective treatment for acute, painful vertebral fractures due to osteoporosis.
The focus of the study is on the physical activity and mobility of participants.
Read more
The main questions the trial aims to answer are:
- Does vertebroplasty lead to increased physical activity as measured by accelerometer?
- Does vertebroplasty lead to increased mobility as measured by GPS (global positioning system)?
- Do physical activity and mobility correlate with pain, disability and quality of life?
Researchers will compare vertebroplasty to sham (simulated surgery without active intervention) to understand if vertebroplasty improves physical activity and mobility.
Participants will
- Undergo vertebroplasty or sham procedure
- Wear an accelerometer and a GPS-reciever in a belt for 1 week before to 4 weeks after the surgery
- Answer questionnaires regarding pain, disability and quality of life at regular intervals.
The knowledge gained from this can help determine who would benefit from vertebroplasty.
Read the detailed description
Despite attempts at prevention, osteoporotic vertebral fracture occurs with increasing frequency as lifespans increase.
Patients with this disease can experience severe pain and disability, and when conservative treatment is inadequate, vertebroplasty is an option.
In this surgical procedure, polymethyl metacrylate, or "bone cement" is injected into the fractured vertebral body. However, the procedure is currently controversial for the treatment of osteoporotic vertebral fractures because there is not yet consensus on the efficacy.
By investigating the effect of vertebroplasty on mobility and physical activity, this study aims to contribute to resolution of the controversy.
The study is a prospective, double-blind, randomized, sham-controlled clinical trial, where participants will be randomized to either vertebroplasty or a sham operation.
The study is embedded in the ongoing trial "Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy (VOPE2)" with ClinicalTrials.gov ID NCT06141187.
A subset of the participants in VOPE2 will, in addition to previously planned activities, be equipped with wearable accelerometers and a global positioning system (GPS).
The trial is designed in accordance with the SPIRIT guidelines.
Potential participants will be identified by referral to the Center for Spine Surgery and Research from general practitioners, chiropractor, physiotherapist, or from hospital inpatient and emergency departments in the region of Southern Denmark.
Participants will then be examined in an outpatient clinic by a spine surgeon, and have MRI scans and X-ray images analyzed by experienced neuro-radiologists.
If eligible, they will be offered to participate following informed consent. An accelerometer and GPS-reciever attached to an elastic waist band are initiated following inclusion.
Subjects will initially be stratified into two groups based on the number of OVCFs into 1-2 levels or 3-4 levels.
Within each of these two groups, randomization sheets in varying blocks of 8 with an equal number of PVP and sham patients in each block will be generated using software (www.randomizer.org) and will be placed in numbered, opaque, sealed envelopes.
Treatment group assignment is 1:1 and will be performed by a scrub nurse in the surgical theatre after the patient is draped but prior to skin incision.
Throughout the trial, only the surgeon and the OR-nurse will have knowledge of the treatment assignment.
The patient and all assessors remain blinded to the treatment group throughout the study. Spine surgeons who are experienced in PVP will perform the surgical procedures.
Anaesthesiologists and spine surgeons are present at the facility in case of complications, following recommendations by the National Health Authority and have the capacity/capability to decompress the spinal canal in case of cement leakage
Based on qualitative studies and clinical experience, patients with painful osteoporotic vertebral fractures restrict their movement because of pain.
This in turn leads to reduced physical activity and diminished ability to move oneself around and away from home, defined here as mobility.
If vertebroplasty is effective, it is expected to lead to increased physical activity and mobility compared to sham, and the outcomes derived from accelerometers and GPS-recievers can supplement patient reports due to their continuous and objective nature.
- Being tested
- Vertebroplasty, Sham Vertebroplasty
- Keywords
- Accelerometer, Global Positioning System, Vertebroplasty, Physical Activity, Mobility, Osteoporosis, Spinal Surgery, ActiGraph, Accelerometry, GPS, Osteoporotic
- Medical subject headings
- Motor Activity, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VertebroplastyProcedure or surgery
Also called Percutaneous vertebroplasty, PVP
Polymethyl-methacrylate (PMMA) cement is injected slowly into the vertebral body under constant bi-plane fluoroscopy
Sham VertebroplastyProcedure or surgery
A short needle is passed through the skin, but not as far as the periosteum. PMMA is mixed to mimic the PVP procedure but not injected into the vertebral body.
| Study group | Role | What they receive |
|---|---|---|
| Vertebroplasty | Active comparator | Polymethyl-methacrylate (PMMA) cement is prepared and injected slowly into the vertebral body under constant bi-plane fluoroscopy
Interventions:
Procedure: Vertebroplasty Receives: Procedure: Vertebroplasty |
| Sham vertebroplasty | Sham comparator | A short needle is passed through the skin, but not as far as the periosteum. PMMA is mixed to mimic the PVP procedure but not injected into the vertebral body.
Interventions:
Procedure: Sham Vertebroplasty Receives: Procedure: Sham Vertebroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity before and after intervention
Physical activity is measured by accelerometer and presented as mean ENMO (euclidian norm minus one) and mean TAC/d (total activity count per day).
An unweighted average of valid days within the preoperative week is compared with the unweighted average of valid days within the four postoperative weeks by relative change in percent.
Measured: One week preoperatively to the end of the fourth postoperative week.
Secondary outcomes (10)
Daily and weekly physical activity
Physical activity is measured by accelerometer and presented as difference in mean ENMO (euclidian norm minus one) and mean TAC/d (total activity count per day). Daily means are based on valid wear-time. Weekly means are calculated as unweighted averages of all valid days within the week.
Measured: One week preoperatively to 4 weeks postoperatively
Change in daily and weekly physical activity
Physical activity is measured by accelerometer and presented as difference in mean ENMO (euclidian norm minus one) and mean TAC/d (total activity count per day). Daily means are based on valid wear-time. Weekly means are calculated as unweighted averages of all valid days within the week.
This outcome supplements the primary outcome to cover changes within the full study period. Changes are reported as relative percentages.
Measured: One week preoperatively to 4 weeks postoperatively
Physical activity levels
Based on cut-points applied to the ENMO or count measurements, the valid wear-time is divided into intensity classes "sedentary", "light activity" or "moderate to vigorous activity". Time spent in each class is presented as percentage of valid wear-time.
Measured: One week preoperatively to 4 weeks postoperatively
Change in physical activity levels
Based on cut-points applied to the ENMO or count measurements, the valid wear-time is divided into intensity classes "sedentary", "light activity" or "moderate to vigorous activity". Time spent in each class is presented as percentage of valid wear-time and changes as absolute percentage points.
Measured: One week preoperatively to 4 weeks postoperatively
Total daily distance and change in total daily distance
Total daily distance traveled in meters based on GPS positions. Changes are relative in percentages.
Measured: One week preoperatively to 4 weeks postoperatively
Time spent stationary and change in time spent stationary
Percentage of time spent stationary based on GPS positions relative to the days' recording. Change is absolute percentage points.
Measured: One week preoperatively to 4 weeks postoperatively
Time spent away from home and change in time spent away from home
Percentage of time per day where the GPS records a position away from home relative to the days' recordings. Change is in absolute percentage points.
Measured: One week preoperatively to 4 weeks postoperatively
Patient-reported pain intensity.
Pain intensity over the previous 24 hours using the 100-point visual analog scale, where 0 is no pain and 100 is the worst imaginable pain.
Measured: VAS will be recorded once preoperatively and again 1, 2, 3, 4 and 5 days + 2 and 4 weeks postoperatively.
Patient-reported disability
The patients rate their disability using the Oswestry Disability Index (ODI) questionnaire.
Measured: Preoperatively and at 4 weeks postoperatively
Patient-reported health-related quality of life.
Health-related quality of life. on the EuroQol 5-dimension 5-level (EQ-5D-5L)
Measured: Preoperatively and at 4 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start20 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic Vertebral Compression FracturesStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spine Centre of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikkel Ø Andersen, Prof, MD, Study chair, Spine Centre of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776003
- Sponsor's protocol ID
- 23/40938
- Other IDs
- 112199
- Acronym
- VOPE2 COMPAS
- Status last verified
- Jun 2025
- First submitted
- 9 Jan 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from questionnaires, accelerometers and GPS-records will be made available in an anonymized form to researchers who present a proposal for the use that is reasonable and can be approved by the study authors.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture: a Single-center, Double-blind Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06776003
- Acronym / sponsor ID
- VOPE2 COMPAS / 23/40938
- Keywords
- Accelerometer, Global Positioning System, Vertebroplasty, Physical Activity, Mobility, Osteoporosis, Spinal Surgery, ActiGraph
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Spine Centre of Southern DenmarkUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Jan 2025 (actual)
- 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 aim of this clinical trial is to determine if vertebroplasty is an effective treatment for acute, painful vertebral fractures due to osteoporosis.
The focus of the study is on the physical activity and mobility of participants.
The main questions the trial aims to answer are:
- Does vertebroplasty lead to increased physical activity as measured by accelerometer?
- Does vertebroplasty lead to increased mobility as measured by GPS (global positioning system)?
- Do physical activity and mobility correlate with pain, disability and quality of life?
Researchers will compare vertebroplasty to sham (simulated surgery without active intervention) to understand if vertebroplasty improves physical activity and mobility.
Participants will
- Undergo vertebroplasty or sham procedure
- Wear an accelerometer and a GPS-reciever in a belt for 1 week before to 4 weeks after the surgery
- Answer questionnaires regarding pain, disability and quality of life at regular intervals.
The knowledge gained from this can help determine who would benefit from vertebroplasty.
Detailed description
Despite attempts at prevention, osteoporotic vertebral fracture occurs with increasing frequency as lifespans increase.
Patients with this disease can experience severe pain and disability, and when conservative treatment is inadequate, vertebroplasty is an option.
In this surgical procedure, polymethyl metacrylate, or "bone cement" is injected into the fractured vertebral body. However, the procedure is currently controversial for the treatment of osteoporotic vertebral fractures because there is not yet consensus on the efficacy.
By investigating the effect of vertebroplasty on mobility and physical activity, this study aims to contribute to resolution of the controversy.
The study is a prospective, double-blind, randomized, sham-controlled clinical trial, where participants will be randomized to either vertebroplasty or a sham operation.
The study is embedded in the ongoing trial "Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy (VOPE2)" with ClinicalTrials.gov ID NCT06141187.
A subset of the participants in VOPE2 will, in addition to previously planned activities, be equipped with wearable accelerometers and a global positioning system (GPS).
The trial is designed in accordance with the SPIRIT guidelines.
Potential participants will be identified by referral to the Center for Spine Surgery and Research from general practitioners, chiropractor, physiotherapist, or from hospital inpatient and emergency departments in the region of Southern Denmark.
Participants will then be examined in an outpatient clinic by a spine surgeon, and have MRI scans and X-ray images analyzed by experienced neuro-radiologists.
If eligible, they will be offered to participate following informed consent. An accelerometer and GPS-reciever attached to an elastic waist band are initiated following inclusion.
Subjects will initially be stratified into two groups based on the number of OVCFs into 1-2 levels or 3-4 levels.
Within each of these two groups, randomization sheets in varying blocks of 8 with an equal number of PVP and sham patients in each block will be generated using software (www.randomizer.org) and will be placed in numbered, opaque, sealed envelopes.
Treatment group assignment is 1:1 and will be performed by a scrub nurse in the surgical theatre after the patient is draped but prior to skin incision.
Throughout the trial, only the surgeon and the OR-nurse will have knowledge of the treatment assignment.
The patient and all assessors remain blinded to the treatment group throughout the study. Spine surgeons who are experienced in PVP will perform the surgical procedures.
Anaesthesiologists and spine surgeons are present at the facility in case of complications, following recommendations by the National Health Authority and have the capacity/capability to decompress the spinal canal in case of cement leakage
Based on qualitative studies and clinical experience, patients with painful osteoporotic vertebral fractures restrict their movement because of pain.
This in turn leads to reduced physical activity and diminished ability to move oneself around and away from home, defined here as mobility.
If vertebroplasty is effective, it is expected to lead to increased physical activity and mobility compared to sham, and the outcomes derived from accelerometers and GPS-recievers can supplement patient reports due to their continuous and objective nature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vertebroplasty | Active comparator | Procedure: VertebroplastyPolymethyl-methacrylate (PMMA) cement is prepared and injected slowly into the vertebral body under constant bi-plane fluoroscopy Interventions: Procedure: Vertebroplasty |
| Sham vertebroplasty | Sham comparator | Procedure: Sham VertebroplastyA short needle is passed through the skin, but not as far as the periosteum. PMMA is mixed to mimic the PVP procedure but not injected into the vertebral body. Interventions: Procedure: Sham Vertebroplasty |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged 50+ and diagnosed with symptomatic osteoporotic spinal compression fractures between T6 and L5 (incl).
- Focal tenderness on the level of the vertebral fracture.
- Fractures verified with oedema of the relevant vertebra on the MRI STIR sequence.
- Osteoporotic Fractures type 1-4.
- Fracture involves no more than 4 vertebral body levels.
Key exclusion criteria (11 listed)
- Contra-indications for spine surgery.
- Platelets < 30 mia/l.
- Osteoporotic Fractures type 5 and Pincer-type.
- Complete collapse of the vertebral body precluding insertion of needle.
- Presence of neurologic deficit.
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 |
|---|---|---|
| VertebroplastyAlso: Percutaneous vertebroplasty, PVPPolymethyl-methacrylate (PMMA) cement is injected slowly into the vertebral body under constant bi-plane fluoroscopy | Procedure or surgery | Vertebroplasty |
| Sham VertebroplastyA short needle is passed through the skin, but not as far as the periosteum. PMMA is mixed to mimic the PVP procedure but not injected into the vertebral body. | Procedure or surgery | Sham vertebroplasty |
Primary outcome
Change in physical activity before and after intervention
Time frame: One week preoperatively to the end of the fourth postoperative week.
Physical activity is measured by accelerometer and presented as mean ENMO (euclidian norm minus one) and mean TAC/d (total activity count per day). An unweighted average of valid days within the preoperative week is compared with the unweighted average of valid days within the four postoperative weeks by relative change in percent.
10 secondary outcomes
Daily and weekly physical activity
Time frame: One week preoperatively to 4 weeks postoperatively
Change in daily and weekly physical activity
Time frame: One week preoperatively to 4 weeks postoperatively
Physical activity levels
Time frame: One week preoperatively to 4 weeks postoperatively
Change in physical activity levels
Time frame: One week preoperatively to 4 weeks postoperatively
Total daily distance and change in total daily distance
Time frame: One week preoperatively to 4 weeks postoperatively
Time spent stationary and change in time spent stationary
Time frame: One week preoperatively to 4 weeks postoperatively
Time spent away from home and change in time spent away from home
Time frame: One week preoperatively to 4 weeks postoperatively
Patient-reported pain intensity.
Time frame: VAS will be recorded once preoperatively and again 1, 2, 3, 4 and 5 days + 2 and 4 weeks postoperatively.
Patient-reported disability
Time frame: Preoperatively and at 4 weeks postoperatively
Patient-reported health-related quality of life.
Time frame: Preoperatively and at 4 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Yes. Data from questionnaires, accelerometers and GPS-records will be made available in an anonymized form to researchers who present a proposal for the use that is reasonable and can be approved by the study authors.
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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.
Mikkel Ø Andersen, Prof, MD study chair
Spine Centre of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertebroplasty in people with Osteoporotic Vertebral Compression Fractures, run by Spine Centre of Southern Denmark at 1 site in Denmark.
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 10 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 25 Jun 2025. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Søren W Sørensen, MD (0045 76362000, soren.wittorff.sorensen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity before and after intervention (time frame: One week preoperatively to the end of the fourth postoperative week.). 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 25 Jun 2025.