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Compares treatment options for Osteoporotic Vertebral Compression Fractures
Official title Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture
ClinicalTrials.gov ID: NCT06776003
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kolding, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kolding, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.