<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/NCT03770338</url>
  </required_header>
  <id_info>
    <org_study_id>Teriparatide_RCT</org_study_id>
    <nct_id>NCT03770338</nct_id>
  </id_info>
  <brief_title>Preoperative Teriparatide Use on Insertional Torque of Pedicle Screws for Lumbar Fusion Surgery</brief_title>
  <official_title>Effect of 1 Month Preoperative Teriparatide Use on the Insertional Torque of Pedicle Screws for Lumbar Fusion Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project aims to investigate any difference of insertional torque strength for&#xD;
      osteoporotic patients with preoperative 1-month teriparatide injections versus those without.&#xD;
      The increased insertional torque of pedicle screws during surgery after only 1 month of&#xD;
      teriparatide use has also been studied. However, the effect of teriparatide on vertebral body&#xD;
      bone mineral density (BMD) prior to and after fusion surgery has not been studied. The&#xD;
      effects on screw insertional torque has also not been studied via a randomized controlled&#xD;
      trial method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For this project, adult patients (&gt;40 years) undergoing lumbar spinal fusion will be&#xD;
      randomized to undergo teriparatide treatment for 1 month prior to surgery. Patients will have&#xD;
      their baseline BMD assessed by DEXA scan must be considered as osteoporotic (&gt;2.5 SD from&#xD;
      sex-matched young adult, or previous vertebral and/or femoral fractures) and indicated for&#xD;
      spinal fusion surgery to undergo study. Exclusion criteria included Paget disease of bone,&#xD;
      high laboratory tests for serum alkaline phosphatase or calcium, previous radiation treatment&#xD;
      or fusion surgery to lumbar spine, bone tumors, metabolic bone disease, and hypersensitivity&#xD;
      to teriparatide. Surgery involving single- or multi-level lumbar spinal fusion for any of the&#xD;
      conditions: lumbar spinal stenosis, degenerative/isthmic/congenital spondylolisthesis,&#xD;
      degenerative scoliosis. Only the surgeon and assessors will be blinded as patients will know&#xD;
      their treatment arm.&#xD;
&#xD;
      Patients undergo a quantitative CT prior to initiation of teriparatide treatment. After one&#xD;
      month of Teriparatide treatment, the drug is discontinued with another DEXA scan to see the&#xD;
      changes in BMD. A quantitative CT will be performed after surgery and at 6 months&#xD;
      postoperatively. Follow-up schedules include preoperative, immediate postoperative,&#xD;
      postoperative 6 weeks, 3 months, 6 months, 12 months and at 24 months. At all follow-up&#xD;
      timepoints, any complications, fusion demonstrated by cross-trabeculation on x-rays (with&#xD;
      final confirmation at the 6 month CT), and objective questionnaires for quality of life&#xD;
      including the EuroQoL 5 dimensions 5-level questionnaire (EQ-5D-5L), back pain numeric rating&#xD;
      scale (NRS), osteoporosis assessment questionnaire-physical function (OPAQ-PF) and ambulatory&#xD;
      status assessment (ASA) questionnaires will be recorded. Other quality-of-life scores include&#xD;
      ODI and SF-36, along with adherence evaluation of osteoporosis treatment (ADEOS),&#xD;
      osteoporosis attitude questionnaire and osteoporosis knowledge questionnaire. Once a patient&#xD;
      is identified to be suitable for this protocol, they will need to be assessed by a medical&#xD;
      social worker to be unable to afford this entire treatment regimen before institutional&#xD;
      support for the drug treatment is provided.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>To detect any significant difference between control and teriparatide groups in terms of intraoperative insertional torque strength</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insertional torque Intraoperative insertional torque measurement</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Measurement of the insertional torque of pedicle screws</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bone Mineral Density (BMD)</measure>
    <time_frame>Preoperative, Immediate postop and 6 month postop dual energy x-ray absorptiometry (DEXA) scan</time_frame>
    <description>Assessment of BMD before and after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months</time_frame>
    <description>screw loosening, fracture, non-union</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fusion rate</measure>
    <time_frame>At 6 months CT</time_frame>
    <description>Fusion rate assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L</measure>
    <time_frame>Baseline, immediate, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months</time_frame>
    <description>Utility score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index (ODI)</measure>
    <time_frame>Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months</time_frame>
    <description>Assessment of disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short form 36-item questionnaire (SF-36)</measure>
    <time_frame>Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months</time_frame>
    <description>General quality of life score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Rating Scale (NRS)</measure>
    <time_frame>Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months</time_frame>
    <description>This is a self-perceived severity of back pain. The scores range from minimum 0 (no pain) to maximum 10 (most painful) in a scale of severity. Hence, a higher value represents worse outcome. There are two subquestions: 1) What the patient indicates as the most severe pain in the past 24 hours of answering the questionnaire; 2) The patient indicates the score of the usual pain status in the past 24 hours. 0 represents no pain, 1-3 represents mild pain (nagging, annoying, interfering little with ADLs), 4-6 represents moderate pain (interferes significantly with ADLs), and 7-10 represents severe pain (disabling; unable to perform ADLs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF)</measure>
    <time_frame>Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months</time_frame>
    <description>This is a general osteoporosis score with 15 questions split into three categories (mobility, balance and transfer). A Likert scale of 6 answers are possible for each question from &quot;no difficulties&quot; to &quot;unable to perform&quot; in a scale of severity. A total score can be tabulated from adding all domain scores. Higher values indicate better outcome. A 0-100 scale provides a total score, where 0 indicates the worst health status and 100 no difficulties.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambulatory status assessment (ASA)</measure>
    <time_frame>Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months</time_frame>
    <description>Functional assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence evaluation of osteoporosis treatment (ADEOS)</measure>
    <time_frame>Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months</time_frame>
    <description>Osteoporosis treatment assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Osteoporosis attitude and knowledge questionnaire</measure>
    <time_frame>Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months</time_frame>
    <description>To assess patients' understanding of the disease and their views towards osteoporosis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">192</enrollment>
  <condition>Osteoporosis</condition>
  <condition>Fusion of Spine, Lumbar Region</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Recruitment for fusion surgery as usual</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Teriparatide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preoperative 1 month use of teriparatide, before lumbar fusion surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teriparatide</intervention_name>
    <description>20ug dosage daily injection, 1-month preoperative</description>
    <arm_group_label>Teriparatide</arm_group_label>
    <other_name>Forteo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be osteoporotic: baseline BMD assessed by DEXA scan must be considered&#xD;
             as osteoporotic (&gt;2.5 SD from sex-matched young adult, or previous vertebral and/or&#xD;
             femoral fractures) and indicated for spinal fusion surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Paget disease of bone, high laboratory tests for serum alkaline phosphatase or&#xD;
             calcium, previous radiation treatment or fusion surgery to lumbar spine, bone tumors,&#xD;
             metabolic bone disease, and hypersensitivity to teriparatide&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jason Pui Yin Cheung</name>
      <address>
        <city>Hong Kong</city>
        <state>Please Select An Option Below</state>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason Pui Yin Cheung</last_name>
      <phone>22554581</phone>
      <email>cheungjp@hku.hk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Duchess of Kent Children's Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason Cheung</last_name>
      <phone>+85222554581</phone>
      <email>cheungjp@hku.hk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason Cheung</last_name>
      <phone>+85222554581</phone>
      <email>cheungjp@hku.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>osteoporosis, teriparatide, insertional torque</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Teriparatide</mesh_term>
  </intervention_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/NCT03770338
org study id: Teriparatide_RCT
nct id: NCT03770338
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This project aims to investigate any difference of insertional torque strength for
      osteoporotic patients with preoperative 1-month teriparatide injections versus those without.
      The increased insertional torque of pedicle screws during surgery after only 1 month of
      teriparatide use has also been studied. However, the effect of teriparatide on vertebral body
      bone mineral density (BMD) prior to and after fusion surgery has not been studied. The
      effects on screw insertional torque has also not been studied via a randomized controlled
      trial method.
For this project, adult patients (>40 years) undergoing lumbar spinal fusion will be
      randomized to undergo teriparatide treatment for 1 month prior to surgery. Patients will have
      their baseline BMD assessed by DEXA scan must be considered as osteoporotic (>2.5 SD from
      sex-matched young adult, or previous vertebral and/or femoral fractures) and indicated for
      spinal fusion surgery to undergo study. Exclusion criteria included Paget disease of bone,
      high laboratory tests for serum alkaline phosphatase or calcium, previous radiation treatment
      or fusion surgery to lumbar spine, bone tumors, metabolic bone disease, and hypersensitivity
      to teriparatide. Surgery involving single- or multi-level lumbar spinal fusion for any of the
      conditions: lumbar spinal stenosis, degenerative/isthmic/congenital spondylolisthesis,
      degenerative scoliosis. Only the surgeon and assessors will be blinded as patients will know
      their treatment arm.

      Patients undergo a quantitative CT prior to initiation of teriparatide treatment. After one
      month of Teriparatide treatment, the drug is discontinued with another DEXA scan to see the
      changes in BMD. A quantitative CT will be performed after surgery and at 6 months
      postoperatively. Follow-up schedules include preoperative, immediate postoperative,
      postoperative 6 weeks, 3 months, 6 months, 12 months and at 24 months. At all follow-up
      timepoints, any complications, fusion demonstrated by cross-trabeculation on x-rays (with
      final confirmation at the 6 month CT), and objective questionnaires for quality of life
      including the EuroQoL 5 dimensions 5-level questionnaire (EQ-5D-5L), back pain numeric rating
      scale (NRS), osteoporosis assessment questionnaire-physical function (OPAQ-PF) and ambulatory
      status assessment (ASA) questionnaires will be recorded. Other quality-of-life scores include
      ODI and SF-36, along with adherence evaluation of osteoporosis treatment (ADEOS),
      osteoporosis attitude questionnaire and osteoporosis knowledge questionnaire. Once a patient
      is identified to be suitable for this protocol, they will need to be assessed by a medical
      social worker to be unable to afford this entire treatment regimen before institutional
      support for the drug treatment is provided.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: To detect any significant difference between control and teriparatide groups in terms of intraoperative insertional torque strength
primary purpose: Other
masking: None (Open Label)
measure: Insertional torque Intraoperative insertional torque measurement
time frame: Intraoperative
description: Measurement of the insertional torque of pedicle screws
measure: Bone Mineral Density (BMD)
time frame: Preoperative, Immediate postop and 6 month postop dual energy x-ray absorptiometry (DEXA) scan
description: Assessment of BMD before and after treatment
measure: Complication rate
time frame: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
description: screw loosening, fracture, non-union
measure: Fusion rate
time frame: At 6 months CT
description: Fusion rate assessment
measure: EQ-5D-5L
time frame: Baseline, immediate, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
description: Utility score
measure: Oswestry Disability Index (ODI)
time frame: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
description: Assessment of disability
measure: Short form 36-item questionnaire (SF-36)
time frame: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
description: General quality of life score
measure: Numeric Rating Scale (NRS)
time frame: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
description: This is a self-perceived severity of back pain. The scores range from minimum 0 (no pain) to maximum 10 (most painful) in a scale of severity. Hence, a higher value represents worse outcome. There are two subquestions: 1) What the patient indicates as the most severe pain in the past 24 hours of answering the questionnaire; 2) The patient indicates the score of the usual pain status in the past 24 hours. 0 represents no pain, 1-3 represents mild pain (nagging, annoying, interfering little with ADLs), 4-6 represents moderate pain (interferes significantly with ADLs), and 7-10 represents severe pain (disabling; unable to perform ADLs).
measure: Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF)
time frame: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
description: This is a general osteoporosis score with 15 questions split into three categories (mobility, balance and transfer). A Likert scale of 6 answers are possible for each question from "no difficulties" to "unable to perform" in a scale of severity. A total score can be tabulated from adding all domain scores. Higher values indicate better outcome. A 0-100 scale provides a total score, where 0 indicates the worst health status and 100 no difficulties.
measure: Ambulatory status assessment (ASA)
time frame: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
description: Functional assessment
measure: Adherence evaluation of osteoporosis treatment (ADEOS)
time frame: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
description: Osteoporosis treatment assessment
measure: Osteoporosis attitude and knowledge questionnaire
time frame: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
description: To assess patients' understanding of the disease and their views towards osteoporosis
arm group label: Control
arm group type: No Intervention
description: Recruitment for fusion surgery as usual
arm group label: Teriparatide
arm group type: Experimental
description: Preoperative 1 month use of teriparatide, before lumbar fusion surgery
intervention type: Drug
intervention name: Teriparatide
description: 20ug dosage daily injection, 1-month preoperative
arm group label: Teriparatide
other name: Forteo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Teriparatide