Quality of Life After Vertebroplasty Versus Conservative Treatment in Patients With Painful Osteoporotic Vertebral Fractures
Analysis of the Impact in the Quality of Life of Patients With Pain Secondary to Osteoporotic Vertebral Fractures Receiving Conservative Treatment Versus Percutaneous Vertebroplasty
1 other identifier
interventional
120
1 country
1
Brief Summary
The purpose of this study is to determine whether percutaneous vertebroplasty is able to improve long-term quality of life in patients with pain secondary to osteoporotic vertebral fractures, compared to conventional medical treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 13, 2009
CompletedFirst Posted
Study publicly available on registry
October 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFebruary 23, 2017
February 1, 2017
5.3 years
October 13, 2009
February 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Impact into quality of life with the Qualeffo-41 test
Baseline, 2 weeks, 2 months, 6 months and 1 year
Secondary Outcomes (1)
Analyze pain alleviation with the Analog Visual Scale
Baseline, 2 weeks, 2 months, 6 months and 1 year
Study Arms (2)
vertebroplasty
ACTIVE COMPARATORMedical Treatment
ACTIVE COMPARATORInterventions
percutaneous injection of cement into the vertebral body
Eligibility Criteria
You may qualify if:
- Painful (pain intensity of at least 4 on a scale from 0 to 10) osteoporotic vertebral fracture between levels T4 and L5
- Fragility; i.e. fracture not in relation with significant trauma
You may not qualify if:
- No vertebral edema on STIR MR images
- Uncorrectable bleeding diatheses
- Active infection
- Substantial retropulsion of bony fragments
- Non-osteoporotic fracture
- Concomitant neoplasm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clinic of Barcelona
Barcelona, Catalonia, 08036, Spain
Related Publications (1)
Blasco J, Martinez-Ferrer A, Macho J, San Roman L, Pomes J, Carrasco J, Monegal A, Guanabens N, Peris P. Effect of vertebroplasty on pain relief, quality of life, and the incidence of new vertebral fractures: a 12-month randomized follow-up, controlled trial. J Bone Miner Res. 2012 May;27(5):1159-66. doi: 10.1002/jbmr.1564.
PMID: 22513649DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jordi Blasco, MD
Hospital Clinic of Barcelona
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 13, 2009
First Posted
October 14, 2009
Study Start
March 1, 2006
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
February 23, 2017
Record last verified: 2017-02