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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00994032
Other study ID # HCPB-VP
Secondary ID
Status Completed
Phase N/A
First received October 13, 2009
Last updated February 22, 2017
Start date March 2006
Est. completion date June 1, 2011

Study information

Verified date February 2017
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date June 1, 2011
Est. primary completion date June 1, 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
percutaneous injection of cement into the vertebral body
percutaneous injection of cement into the vertebral body
Other:
Medical treatment
standard antalgic medical treatment

Locations

Country Name City State
Spain Hospital Clinic of Barcelona Barcelona Catalunya

Sponsors (2)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona Sociedad Española de Radiologia Medica

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Impact into quality of life with the Qualeffo-41 test Baseline, 2 weeks, 2 months, 6 months and 1 year
Secondary Analyze pain alleviation with the Analog Visual Scale Baseline, 2 weeks, 2 months, 6 months and 1 year
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