- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01677806
Safety and Efficacy Study of Percutaneous Vertebroplasty for Painful Acute Osteoporotic Spine Fractures
Investigational Percutaneous Vertebroplasty Efficacy and Safety Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Osteoporotic vertebral fractures (OVCFs) are common in the elderly population, with an estimated 1.4 million new fractures occurring every year worldwide. Patients may present with pain and frequently require hospital admission for analgesia, bed rest, and physical support (bracing). While their back pain may last for 6-12 weeks, complications such as pneumonia, decubitus ulcers, venous thromboembolism, and even death may occur. Percutaneous vertebroplasty (PVP) is now a therapeutic option for individuals for whom medical management has not been successful or for those who are at risk for developing complications due to long-term immobilization. Recently, three randomized controlled trials (RCT) concerning PVP have been published with conflicting results. So this study is to compare PVP with conservative therapy in patients with osteoporotic VCFs. Moreover, this study addresses concerns about the possibility that PVP increases the incidence of new compression fractures in adjacent vertebrae.
This study is a multicenter randomized controlled trial (RCT), Participants in this study will be allocated randomly to PVP or conservative treatment.All Participants will be asked to fill out standard questionnaires to provide clinical information at baseline (the day of randomization), and at 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after the treatment. Cross-over will not be offered before 12 months after randomization. All standard questionnaires (except the 1-day questionnaire) consist of the VAS score, Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO), EQ-5D, and Roland-Morris Disability (RMD) Questionnaire. Furthermore,additional questions about pain treatment, hospital stay, outpatient visits,medical aids, and medical costs will be completed with the help of a nurse practitioner.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Shandong
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Jinan, Shandong, China, 250031
- The Jinan Military General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 50 Years and older
- have a confirmed diagnosis of osteoporosis or osteopenia.
- acute, painful OVCFs from T4-L5
- clinical onset < 6 weeks
- vertebral compression fracture on spine radiograph (minimum 15% height loss)
- Visual Analogue Scale [VAS] score ≥ 4 for pain
Exclusion Criteria:
- severe cardio-pulmonary condition
- untreatable coagulopathy
- active local or systemic infection
- current malignancy, or radicular or caudal compression syndrome
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Percutaneous vertebroplasty
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Percutaneous vertebroplasty Placement of PMMA into vertebral compression fracture
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Active Comparator: Conservative therapy
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Conservative therapy mainly consists of optimal pain medication.
Pain management is titrated according to patients' needs, including analgesia, bed rest, and physical support (bracing).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS score
Time Frame: at 1 month
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Pain assessment is based on the VAS scale, a scale from 0 (no pain) to 10 (worst pain ever), for which a decrease of 3.0 or more points from baseline is considered to be clinically significant pain relief.
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at 1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QUALEFFO total score
Time Frame: at baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after the treatment.
|
QUALEFFO total score is measured with the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO).
This questionnaire consists of 41 items and includes five domains: pain, physical function, social function, general health perception, and mental function.
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at baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after the treatment.
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ED-5Q score
Time Frame: at baseline, 1-week, and 1-, 3-, 6-, and 12- month
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EQ-5D is a standardized instrument utilized as a measure of health-related quality of life outcomes.
Furthermore, EQ-5D is one of a few measures recommended for use in cost-effectiveness analyses by the Washington Panel on Cost Effectiveness in Health & Medicine as well as in National guidelines in economic evaluation.
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at baseline, 1-week, and 1-, 3-, 6-, and 12- month
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RMD score
Time Frame: at baseline, 1-week, and 1-, 3-, 6-, and 12- month
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The RMD questionnaire is a disability questionnaire that measures the functional status of patients with back pain.
RMD scores range from 0 to 24, with higher numbers indicating worse physical functioning.
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at baseline, 1-week, and 1-, 3-, 6-, and 12- month
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New vertebral fractures
Time Frame: at baseline, 1 month, 3 months, and 1 year.
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New vertebral fractures are defined as a decrease (compared with baseline radiographs) of 20% or more, and at least 4 mm, in any of the three vertebral heights (anterior, middle, or posterior) on follow-up.
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at baseline, 1 month, 3 months, and 1 year.
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Total medical costs
Time Frame: at 1-month, 12-month
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This study will calculate total medical costs through summarizing all costs of drugs,family doctor,physiotherapist, hospital stay, and outpatient visits, etc.
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at 1-month, 12-month
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gang Sun, M.D, The Jinan Military General Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JNMGH20120821
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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