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
Verified date | February 2017 |
Source | Hospital Clinic of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinic of Barcelona | Barcelona | Catalunya |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona | Sociedad Española de Radiologia Medica |
Spain,
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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