Vertebroplasty versus sham to see if activity and mobility improve after osteoporotic vertebral fractures
Official title: Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture: a Single-center, Double-blind Randomized Controlled Clinical Trial
Run by Spine Centre of Southern Denmark · NCT06776003 · Data updated 2026-11-12
This study tests whether vertebroplasty, compared with a sham procedure, increases physical activity and mobility in people aged 50+ with recent painful osteoporotic vertebral compression fractures.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 64 (estimated) |
| Sponsor | Spine Centre of Southern Denmark Academic / other |
| Locations | 1 site (Kolding) |
| Status | Recruiting |
| Started | February 20, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | June 25, 2025 |
| Trial ID | NCT06776003 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 50 or older with MRI-confirmed symptomatic osteoporotic vertebral compression fractures (T6–L5), recent pain onset (≤3 months), focal tenderness, and baseline back pain VAS ≥60 who can undergo vertebroplasty and read Danish.
✕Probably not a fit
Patients with chronic or long-standing fractures, neurologic deficits, excluded fracture types (type 5 or pincer), complete vertebral collapse that prevents needle insertion, or other contraindications to surgery or MRI are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, double-blind, randomized, sham-controlled comparison embedded in a larger VOPE2 trial, where participants with acute osteoporotic vertebral compression fractures are randomized to vertebroplasty or a sham procedure. A subset of participants will wear an accelerometer and a GPS receiver in a belt for one week before and four weeks after the procedure to measure physical activity and mobility. Pain, disability, and quality-of-life questionnaires are collected at regular intervals to examine correlations with the wearable data. The trial includes imaging-confirmed fractures (MRI STIR edema) between T6 and L5 and requires pain onset within three months and a baseline VAS pain score ≥60.
Why it matters
Potential benefit: If successful, vertebroplasty could increase daily physical activity and mobility and improve pain, function, and quality of life for people with recent osteoporotic vertebral fractures.
How similar studies have gone: Previous sham-controlled vertebroplasty trials have produced mixed results—some showing little benefit over sham for pain while others suggest possible benefit in selected patients—so the approach remains controversial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.
Where it's running
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Spine Centre of Southern Denmark
Kolding, Denmark Recruiting
Study contacts
- Study coordinator: Søren W Sørensen, MD
- Email: soren.wittorff.sorensen@rsyd.dk
- Phone: 0045 76362000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Vessel-X Bone Filling Container System for Vertebral Augmentation
A new minimally invasive vertebral augmentation approach tests the Vessel-X device to see if it safely improves pain and function in people with osteoporotic vertebral compression fractures.
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Nine-grid Zoning Method to guide vertebroplasty for osteoporotic vertebral fractures
This trial tests whether the Nine-grid Zoning Method can make percutaneous vertebroplasty safer and faster for adults with single-segment lumbar osteoporotic vertebral compression fractures.
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Evaluating treatment outcomes for vertebral compression fractures
This study is testing how well a procedure called vertebroplasty helps adults with osteoporosis-related spine fractures feel better and improve their quality of life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.