<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01677806</url>
  </required_header>
  <id_info>
    <org_study_id>JNMGH20120821</org_study_id>
    <nct_id>NCT01677806</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Percutaneous Vertebroplasty for Painful Acute Osteoporotic Spine Fractures</brief_title>
  <official_title>Investigational Percutaneous Vertebroplasty Efficacy and Safety Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jinan Military General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai 6th People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai 10th People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China Medical University, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jinan Military General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Percutaneous vertebroplasty (PVP) is now a therapeutic option for individuals for whom&#xD;
      medical management has not been successful or for those who are at risk for developing&#xD;
      complications due to long-term immobilization. Recently, three randomized controlled trials&#xD;
      (RCT) concerning PVP have been published with conflicting results. Two RCTs with a sham&#xD;
      control intervention failed to show an advantage of vertebroplasty over placebo for&#xD;
      participants with acute, subacute, and chronic fractures or severe pain. In the third RCT,&#xD;
      PVP compared to optimal conservative treatment showed significant immediate postoperative&#xD;
      pain relief in the vertebroplasty group, but not at 3 and 12 months. To examine these issues,&#xD;
      this study is initiated to compare PVP with conservative therapy in patients with&#xD;
      osteoporotic VCFs. Moreover, this study addresses concerns about the possibility that PVP&#xD;
      increases the incidence of new compression fractures in adjacent vertebrae.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Osteoporotic vertebral fractures (OVCFs) are common in the elderly population, with an&#xD;
      estimated 1.4 million new fractures occurring every year worldwide. Patients may present with&#xD;
      pain and frequently require hospital admission for analgesia, bed rest, and physical support&#xD;
      (bracing). While their back pain may last for 6-12 weeks, complications such as pneumonia,&#xD;
      decubitus ulcers, venous thromboembolism, and even death may occur. Percutaneous&#xD;
      vertebroplasty (PVP) is now a therapeutic option for individuals for whom medical management&#xD;
      has not been successful or for those who are at risk for developing complications due to&#xD;
      long-term immobilization. Recently, three randomized controlled trials (RCT) concerning PVP&#xD;
      have been published with conflicting results. So this study is to compare PVP with&#xD;
      conservative therapy in patients with osteoporotic VCFs. Moreover, this study addresses&#xD;
      concerns about the possibility that PVP increases the incidence of new compression fractures&#xD;
      in adjacent vertebrae.&#xD;
&#xD;
      This study is a multicenter randomized controlled trial (RCT), Participants in this study&#xD;
      will be allocated randomly to PVP or conservative treatment.All Participants will be asked to&#xD;
      fill out standard questionnaires to provide clinical information at baseline (the day of&#xD;
      randomization), and at 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after the&#xD;
      treatment. Cross-over will not be offered before 12 months after randomization. All standard&#xD;
      questionnaires (except the 1-day questionnaire) consist of the VAS score, Quality of Life&#xD;
      Questionnaire of the European Foundation for Osteoporosis (QUALEFFO), EQ-5D, and&#xD;
      Roland-Morris Disability (RMD) Questionnaire. Furthermore,additional questions about pain&#xD;
      treatment, hospital stay, outpatient visits,medical aids, and medical costs will be completed&#xD;
      with the help of a nurse practitioner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">October 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS score</measure>
    <time_frame>at 1 month</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>QUALEFFO total score</measure>
    <time_frame>at baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after the treatment.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ED-5Q score</measure>
    <time_frame>at baseline, 1-week, and 1-, 3-, 6-, and 12- month</time_frame>
    <description>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 &amp; Medicine as well as in National guidelines in economic evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RMD score</measure>
    <time_frame>at baseline, 1-week, and 1-, 3-, 6-, and 12- month</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New vertebral fractures</measure>
    <time_frame>at baseline, 1 month, 3 months, and 1 year.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total medical costs</measure>
    <time_frame>at 1-month, 12-month</time_frame>
    <description>This study will calculate total medical costs through summarizing all costs of drugs,family doctor,physiotherapist, hospital stay, and outpatient visits, etc.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Acute Osteoporotic Spinal Fractures</condition>
  <arm_group>
    <arm_group_label>Percutaneous vertebroplasty</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Conservative therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous vertebroplasty</intervention_name>
    <description>Percutaneous vertebroplasty Placement of PMMA into vertebral compression fracture</description>
    <arm_group_label>Percutaneous vertebroplasty</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conservative therapy</intervention_name>
    <description>Conservative therapy mainly consists of optimal pain medication. Pain management is titrated according to patients' needs, including analgesia, bed rest, and physical support (bracing).</description>
    <arm_group_label>Conservative therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50 Years and older&#xD;
&#xD;
          -  have a confirmed diagnosis of osteoporosis or osteopenia.&#xD;
&#xD;
          -  acute, painful OVCFs from T4-L5&#xD;
&#xD;
          -  clinical onset &lt; 6 weeks&#xD;
&#xD;
          -  vertebral compression fracture on spine radiograph (minimum 15% height loss)&#xD;
&#xD;
          -  Visual Analogue Scale [VAS] score ≥ 4 for pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe cardio-pulmonary condition&#xD;
&#xD;
          -  untreatable coagulopathy&#xD;
&#xD;
          -  active local or systemic infection&#xD;
&#xD;
          -  current malignancy, or radicular or caudal compression syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gang Sun, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Jinan Military General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Jinan Military General Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.jnjqzyy.cn/index.html</url>
    <description>The Jinan Military General Hospital</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jinan Military General Hospital</investigator_affiliation>
    <investigator_full_name>Gang Sun;Chungen Wu;Maoquan Li;Bo Feng; Hai Tang;ZL Deng</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Percutaneous vertebroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Fractures</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01677806
org study id: JNMGH20120821
nct id: NCT01677806
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: VAS score
time frame: at 1 month
description: 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.
measure: QUALEFFO total score
time frame: at baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after the treatment.
description: 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.
measure: ED-5Q score
time frame: at baseline, 1-week, and 1-, 3-, 6-, and 12- month
description: 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.
measure: RMD score
time frame: at baseline, 1-week, and 1-, 3-, 6-, and 12- month
description: 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.
measure: New vertebral fractures
time frame: at baseline, 1 month, 3 months, and 1 year.
description: 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.
measure: Total medical costs
time frame: at 1-month, 12-month
description: This study will calculate total medical costs through summarizing all costs of drugs,family doctor,physiotherapist, hospital stay, and outpatient visits, etc.
arm group label: Percutaneous vertebroplasty
arm group type: Experimental
arm group label: Conservative therapy
arm group type: Active Comparator
intervention type: Procedure
intervention name: Percutaneous vertebroplasty
description: Percutaneous vertebroplasty Placement of PMMA into vertebral compression fracture
arm group label: Percutaneous vertebroplasty
intervention type: Other
intervention name: Conservative therapy
description: Conservative therapy mainly consists of optimal pain medication. Pain management is titrated according to patients' needs, including analgesia, bed rest, and physical support (bracing).
arm group label: Conservative therapy
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Gang Sun, M.D
role: Principal Investigator
affiliation: The Jinan Military General Hospital
facility: 
country: China
url: http://www.jnjqzyy.cn/index.html
description: The Jinan Military General Hospital
responsible party type: Principal Investigator
investigator affiliation: Jinan Military General Hospital
investigator full name: Gang Sun;Chungen Wu;Maoquan Li;Bo Feng; Hai Tang;ZL Deng
investigator title: Clinical Professor
mesh term: Spinal Fractures