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NCT06141187: VOPE2
Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy.
NA trial testing Vertebroplasty in Osteoporotic Fractures in 240 participants. Currently enrolling.
31 December 2028
Quick facts
| Lead sponsor | Spine Centre of Southern Denmark |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 240 |
| Start date | 1 January 2024 |
| Primary completion | 31 December 2028 |
| Estimated completion | 31 December 2030 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Vertebroplasty
- Sham Vertebroplasty
Conditions studied
- Osteoporotic Fractures — all drugs for Osteoporotic Fractures →
- Vertebral Fracture — all drugs for Vertebral Fracture →
Sponsor
Spine Centre of Southern Denmark
Who can join
50 and older, any sex, with Osteoporotic Fractures or Vertebral Fracture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this randomized double-blind clinical trial is to determine the efficacy of percutaneous vertebroplasty (PVP) in relieving severe pain in patients with MRI-verified acute or sub-acute osteoporotic vertebral compression fractures (OVCFs) compared to sham as well as examine the socio-economic implications associated with performing vertebroplasty. The primary outcome is improvement of pain intensity as measured on a Visual Analog Scale (VAS, 0 to100) 12 weeks after treatment. Secondary outcomes include patient-reported back-related disability, patient-reported quality of life, spinal sagittal balance, complications associated with the procedure, incidence of new OVCFs and socioeconomic costs.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Vertebroplasty for painful osteoporotic vertebral compression fractures: a protocol for a single-center doubled-blind randomized sham-controlled clinical trial. VOPE2.
Andersen MØ, Andresen AK, Hartvigsen J, Hermann AP, et al · · 2024 · cited 41× · PMID 39614265 · DOI 10.1186/s13018-024-05301-x -
Percutaneous Vertebroplasty and Balloon Kyphoplasty for Painful Osteoporotic Vertebral Compression Fractures: A Health Technology Assessment.
Ontario Health (Quality) . · · 2025 · PMID 40950842
Verify or expand the search:
- PubMed search for NCT06141187
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Vertebroplasty
Trials testing the same drug.
- NCT06670404 — Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures · recruiting
- NCT05317026 — Increased Early Pain Relief by Adding Vertebroplasty to SBRT · NA · recruiting
- NCT05178472 — Vertebroplasty With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria) · NA · recruiting
- NCT04533217 — Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma. · NA · recruiting
- NCT07507565 — Comparison of Analgetic Therapies in Traumatic Vertebral Compression Fractures: Vertebroplasty vs Thermal Facet Ablation · NA · active not recruiting
Other recruiting trials for Osteoporotic Fractures
Currently open trials in the same condition.
- NCT07027306 — The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fract · recruiting
- NCT06455085 — RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE · NA · recruiting
- NCT05866029 — Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture · NA · recruiting
- NCT05927623 — Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men · NA · active not recruiting
- NCT06367582 — Spine Bone Cements Outcomes - Post Market Follow-up · recruiting
Other Spine Centre of Southern Denmark trials
Trials by the same sponsor.
- NCT05115227 — Long-term Multidisciplinary Team-based Management of Back Pain · NA · completed
- NCT04406987 — Instability in the Lumbar Spine of Patients With Age Related Changes and Narrowing of the Spinal Canal (Spinal Stenosis) · completed
- NCT04888026 — Impact on Pain Sensitivity of Clinical Interaction · NA · completed
- NCT04533217 — Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma. · NA · recruiting
- NCT04193969 — Changes in Radicular Pain and Pain Modulation · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06141187 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Spine Centre of Southern Denmark
- Last refreshed: 6 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06141187.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing