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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 because the information has not been verified recently.
Verified October 2009 by Hospital Clinic of Barcelona.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Sociedad Española de Radiologia Medica
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00994032
First received: October 13, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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
Osteoporosis
Back Pain
 Procedure: percutaneous injection of cement into the vertebral body
Other: Medical treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analyze pain alleviation with the Analog Visual Scale [ Time Frame: Baseline, 2 weeks, 2 months, 6 months and 1 year ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994032

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

Additional Information:
International Osteoporosis Foundation  This link exits the ClinicalTrials.gov site

No publications provided by Hospital Clinic of Barcelona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jordi Blasco Andaluz, MD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00994032     History of Changes
Other Study ID Numbers: HCPB-VP
Study First Received: October 13, 2009
Last Updated: October 13, 2009
Health Authority: Spain: Ethics Committee

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

Additional relevant MeSH terms:
Back Pain
Fractures, Bone
Osteoporosis
Spinal Fractures
Pain
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Spinal Injuries
Back Injuries

ClinicalTrials.gov processed this record on May 16, 2013