Clinical trial NCT01677806: Safety and Efficacy Study of Percutaneous Vertebroplasty for Painful Acute Osteoporotic Spine Fractures
Official title: Investigational Percutaneous Vertebroplasty Efficacy and Safety Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Osteoporotic Spinal Fractures
Keywords: Percutaneous vertebroplasty
Lead sponsor: Jinan Military General Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai 6th People's Hospital
name: Shanghai 10th People's Hospital
name: China Medical University, China
name: Beijing Friendship Hospital
name: The Second Affiliated Hospital of Chongqing Medical University
First posted: 2012-09-03
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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. Two RCTs with a sham control intervention failed to show an advantage of vertebroplasty over placebo for participants with acute, subacute, and chronic fractures or severe pain. In the third RCT, PVP compared to optimal conservative treatment showed significant immediate postoperative pain relief in the vertebroplasty group, but not at 3 and 12 months. To examine these issues, this study is initiated 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS score
timeFrame: at 1 month
Secondary outcomes:
measure: QUALEFFO total score
timeFrame: at baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after the treatment.
measure: ED-5Q score
timeFrame: at baseline, 1-week, and 1-, 3-, 6-, and 12- month
measure: RMD score
timeFrame: at baseline, 1-week, and 1-, 3-, 6-, and 12- month
measure: New vertebral fractures
timeFrame: at baseline, 1 month, 3 months, and 1 year.
measure: Total medical costs
timeFrame: at 1-month, 12-month
Other outcomes:
Locations:
city: Jinan
country: China
facility: The Jinan Military General Hospital
state: Shandong
Study officials:
affiliation: The Jinan Military General Hospital
name: Gang Sun, M.D
role: PRINCIPAL_INVESTIGATOR
References: