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Quality of Life After Vertebroplasty Versus Conservative Treatment in Patients With Painful Osteoporotic Vertebral Fractures

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Hospital Clinic of Barcelona.
Recruitment status was:  Active, not recruiting
Sociedad Española de Radiologia Medica
Information provided by:
Hospital Clinic of Barcelona Identifier:
First received: October 13, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
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.

Condition Intervention
Spinal Fracture
Back Pain
Procedure: percutaneous injection of cement into the vertebral body
Other: Medical treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Analysis of the Impact in the Quality of Life of Patients With Pain Secondary to Osteoporotic Vertebral Fractures Receiving Conservative Treatment Versus Percutaneous Vertebroplasty

Resource links provided by NLM:

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Impact into quality of life with the Qualeffo-41 test [ Time Frame: Baseline, 2 weeks, 2 months, 6 months and 1 year ]

Secondary Outcome Measures:
  • Analyze pain alleviation with the Analog Visual Scale [ Time Frame: Baseline, 2 weeks, 2 months, 6 months and 1 year ]

Estimated Enrollment: 100
Study Start Date: March 2006
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vertebroplasty Procedure: percutaneous injection of cement into the vertebral body
percutaneous injection of cement into the vertebral body
Active Comparator: Medical Treatment Other: Medical treatment
standard antalgic medical treatment

Detailed Description:

Osteoporotic vertebral fractures are associated with pain and severe disability in a high percentage of patients. Vertebroplasty has become the treatment of choice to alleviate pain in those patients who have not responded to medical treatment.Although several case series and non-randomized studies have shown the effectiveness of vertebroplasty in alleviating pain secondary to osteoporotic vertebral fractures, the long-term effect of this treatment has not been compared to standard medical treatment in a randomized study.

In our study we have analyzed the long-term effect of vertebroplasty in terms of quality of life in patients with painful osteoporotic vertebral fractures, randomizing them into two arms: percutaneous vertebroplasty or conventional medical treatment.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • Recent fracture, pain beginning not earlier than 1 year before inclusion

Exclusion Criteria:

  • No vertebral edema on STIR MR images
  • Uncorrectable bleeding diatheses
  • Active infection
  • Substantial retropulsion of bony fragments
  • Non-osteoporotic fracture
  • Concomitant neoplasm
  Contacts and Locations
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Please refer to this study by its identifier: NCT00994032

Hospital Clinic of Barcelona
Barcelona, Catalunya, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Sociedad Española de Radiologia Medica
Principal Investigator: Jordi Blasco, MD Hospital Clinic of Barcelona
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jordi Blasco Andaluz, MD, Hospital Clinic of Barcelona Identifier: NCT00994032     History of Changes
Other Study ID Numbers: HCPB-VP 
Study First Received: October 13, 2009
Last Updated: October 13, 2009

Keywords provided by Hospital Clinic of Barcelona:
disability evaluation
outcome assessment
pain measurement

Additional relevant MeSH terms:
Fractures, Bone
Back Pain
Spinal Fractures
Wounds and Injuries
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Spinal Injuries
Back Injuries processed this record on February 20, 2017