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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994032
• Other study ID #: HCPB-VP
• 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
• 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

Related Conditions & MeSH terms

• Back Pain
• Fractures, Bone
• Osteoporosis
• Spinal Fracture
• Spinal Fractures

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

External Links

•   International Osteoporosis Foundation