Acute Osteoporotic Spinal FracturesPhase 3NCT01677806
Safety and Efficacy Study of Percutaneous Vertebroplasty for Painful Acute Osteoporotic Spine Fractures
A Phase 3 study testing Percutaneous vertebroplasty and Conservative therapy in people with Acute Osteoporotic Spinal Fractures, run by Jinan Military General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Acute Osteoporotic Spinal Fractures
- What is being tested?
- Percutaneous vertebroplasty and Conservative therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- severe cardio-pulmonary condition
- untreatable coagulopathy
- active local or systemic infection
- current malignancy, or radicular or caudal compression syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigational Percutaneous Vertebroplasty Efficacy and Safety Trial
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.
Read the 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.
- Conditions
- Acute Osteoporotic Spinal Fractures
- Being tested
- Percutaneous vertebroplasty, Conservative therapy
- Keywords
- Percutaneous vertebroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous vertebroplastyProcedure or surgery
Percutaneous vertebroplasty Placement of PMMA into vertebral compression fracture
Conservative therapyOther
Conservative therapy mainly consists of optimal pain medication. Pain management is titrated according to patients' needs, including analgesia, bed rest, and physical support (bracing).
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous vertebroplasty | Experimental | Not described Receives: Procedure: Percutaneous vertebroplasty |
| Conservative therapy | Active comparator | Not described Receives: Other: Conservative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
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.
Measured: at 1 month
Secondary outcomes (5)
QUALEFFO total score
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.
Measured: at baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after the treatment.
ED-5Q score
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.
Measured: at baseline, 1-week, and 1-, 3-, 6-, and 12- month
RMD score
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.
Measured: at baseline, 1-week, and 1-, 3-, 6-, and 12- month
New vertebral fractures
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.
Measured: at baseline, 1 month, 3 months, and 1 year.
Total medical costs
This study will calculate total medical costs through summarizing all costs of drugs,family doctor,physiotherapist, hospital stay, and outpatient visits, etc.
Measured: at 1-month, 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Osteoporotic Spinal FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinan Military General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 6th People's Hospital, Shanghai 10th People's Hospital, China Medical University, China, Beijing Friendship Hospital, The Second Affiliated Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Gang Sun;Chungen Wu;Maoquan Li;Bo Feng; Hai Tang;ZL Deng, Jinan Military General Hospital
- Investigators
- Gang Sun, M.D, Principal investigator, The Jinan Military General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677806
- Sponsor's protocol ID
- JNMGH20120821
- Status last verified
- Sep 2014
- First submitted
- 23 Aug 2012
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigational Percutaneous Vertebroplasty Efficacy and Safety Trial
- ClinicalTrials.gov ID
- NCT01677806
- Acronym / sponsor ID
- JNMGH20120821
- Conditions
- Acute Osteoporotic Spinal Fractures
- Keywords
- Percutaneous vertebroplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Jinan Military General HospitalUniversity, hospital or other
- Collaborators
- Shanghai 6th People's Hospital, Shanghai 10th People's Hospital, China Medical University, China, Beijing Friendship Hospital, The Second Affiliated Hospital of Chongqing Medical University
- Study start
- Oct 2012
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 3 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous vertebroplasty | Experimental | Procedure: Percutaneous vertebroplasty |
| Conservative therapy | Active comparator | Other: Conservative therapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- severe cardio-pulmonary condition
- untreatable coagulopathy
- active local or systemic infection
- current malignancy, or radicular or caudal compression syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous vertebroplastyPercutaneous vertebroplasty Placement of PMMA into vertebral compression fracture | Procedure or surgery | Percutaneous vertebroplasty |
| Conservative therapyConservative therapy mainly consists of optimal pain medication. Pain management is titrated according to patients' needs, including analgesia, bed rest, and physical support (bracing). | Other | Conservative therapy |
Primary outcome
VAS score
Time frame: at 1 month
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.
5 secondary outcomes
QUALEFFO total score
Time frame: at baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after the treatment.
ED-5Q score
Time frame: at baseline, 1-week, and 1-, 3-, 6-, and 12- month
RMD score
Time frame: at baseline, 1-week, and 1-, 3-, 6-, and 12- month
New vertebral fractures
Time frame: at baseline, 1 month, 3 months, and 1 year.
Total medical costs
Time frame: at 1-month, 12-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Sun, M.D principal investigator
The Jinan Military General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Percutaneous vertebroplasty and Conservative therapy in people with Acute Osteoporotic Spinal Fractures, run by Jinan Military General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2014.