Overview

This trial is active, not recruiting.

Conditions spinal fracture, osteoporosis, back pain
Treatments percutaneous injection of cement into the vertebral body, medical treatment
Sponsor Hospital Clinic of Barcelona
Collaborator Sociedad Española de Radiologia Medica
Start date March 2006
End date June 2009
Trial size 100 participants
Trial identifier NCT00994032, HCPB-VP

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
percutaneous injection of cement into the vertebral body
percutaneous injection of cement into the vertebral body
(Active Comparator)
medical treatment
standard antalgic medical treatment

Primary Outcomes

Measure
Impact into quality of life with the Qualeffo-41 test
time frame: Baseline, 2 weeks, 2 months, 6 months and 1 year

Secondary Outcomes

Measure
Analyze pain alleviation with the Analog Visual Scale
time frame: Baseline, 2 weeks, 2 months, 6 months and 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Jordi Blasco, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2009.
Information provided to ClinicalTrials.gov by Hospital Clinic of Barcelona.