Vertebroplasty versus sham to see if activity and mobility improve after osteoporotic vertebral fractures
Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture: a Single-center, Double-blind Randomized Controlled Clinical Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Spine Centre of Southern Denmark Academic / other |
| Locations | 1 site (Kolding) |
| Trial ID | NCT06776003 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Kolding
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.