<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/NCT03812991</url>
  </required_header>
  <id_info>
    <org_study_id>2013172</org_study_id>
    <nct_id>NCT03812991</nct_id>
  </id_info>
  <brief_title>The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries</brief_title>
  <official_title>The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Missouri-Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Missouri-Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pelvic ring fractures in the geriatric population are a rising problem for surgeons in&#xD;
      industrialized countries. Many of these low-energy fractures are treated nonoperatively;&#xD;
      however, pain is a significant factor in recovery of these patients and often inhibits their&#xD;
      ability to mobilize. Most of these fractures are lateral compression type 1 injuries which&#xD;
      are defined as an impaction to the sacrum with varying amounts of anterior/pubic root/rami&#xD;
      fractures. Many of these patients in the geriatric population suffer from osteoporosis and&#xD;
      the injuries are often sustained from a low-energy mechanism like a fall. The tenet of&#xD;
      treatment for all osteoporotic fractures is early mobilization. It is well known that&#xD;
      extended periods of bed rest will lead to pneumonia, decubitus ulceration, deep venous&#xD;
      thrombosis, and, in the case of the pelvis, not prevent subsequent deformity. Calcitonin is a&#xD;
      polypeptide containing 32 amino acids, and it plays a role in the regulation of bone&#xD;
      metabolism as a hormone that prevents bone resorption. Intranasal salmon calcitonin (ISC) has&#xD;
      been demonstrated to decrease pain and improve the level of activity in patients with acute&#xD;
      vertebral osteoporotic compression fractures when administered within the first 5 days of&#xD;
      onset of pain/injury. It has also demonstrated an immediate post analgesic effect in&#xD;
      osteoporotic distal radius fractures treated nonoperatively. The antihyperalgesic action of&#xD;
      calcitonin appears to be mediated by serotonin receptors. The purpose of this study is to&#xD;
      evaluate the analgesic effect of ISC on geriatric patients with pelvic ring injuries who are&#xD;
      treated nonoperatively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Baseline: Treatment group will be prescribed 200IU of ISC daily for a period of 3 months. The&#xD;
      control group will not be prescribed calcitonin. Participants will complete research only&#xD;
      Iowa pelvis score questionnaire, SF-36 questionnaire and visual analogue scale (VAS) to&#xD;
      assess subjective pain and function. Two-week follow up visit post discharge: participants&#xD;
      will complete Iowa pelvis score questionnaire, SF-36 questionnaire and VAS to assess&#xD;
      subjective pain and function. Participants will be referred for a standard of care DEXA bone&#xD;
      density scan if they have no previous diagnosis of osteoporosis and no history of previous&#xD;
      scan within a year. Six weeks post discharge: participants will complete Iowa pelvis score&#xD;
      questionnaire, SF-36 questionnaire and VAS to assess subjective pain and function.&#xD;
      Participants will undergo standard of care radiographic analysis of pelvic ring injury with&#xD;
      AP/inlet and outlet pelvic x-rays 4. Twelve weeks post discharge: Participants will complete&#xD;
      Iowa pelvis score questionnaire, SF-36 questionnaire and VAS to assess subjective pain and&#xD;
      function. Participants will undergo standard of care radiographic analysis of pelvic ring&#xD;
      injury with AP/inlet and outlet pelvic x-rays - Participants will perform a timed up and go&#xD;
      (TUG) test.&#xD;
&#xD;
      After informed consent is obtained, all patients who meet eligibility criteria will be&#xD;
      randomized into one of two groups. Randomization will be achieved by numbering 50 sealed&#xD;
      white envelopes (25 control, 25 treatment). There is no blinding to the randomization. It&#xD;
      would be difficult to blind the participants, or the research personnel. We do not believe&#xD;
      there will be any significant bias that can be corrected with blinding.&#xD;
&#xD;
      Treatment: 200IUof ISC daily for a period of 3 month&#xD;
&#xD;
      Control: Will not be prescribed calcitonin (ISC)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">February 28, 2023</completion_date>
  <primary_completion_date type="Actual">September 30, 2022</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Concentration of acute pain in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin</measure>
    <time_frame>The subject will be enrolled/assessed up to three months post-injury.</time_frame>
    <description>Compare acute pain using (Visual Analogue Scale; 0-10; 0=no pain; 10= worst pain imaginable) over a three-month period in geriatric patients with pelvic ring injuries who receive intranasal salmon calcitonin with those who do not receive intranasal salmon calcitonin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate functional outcomes in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin</measure>
    <time_frame>The subject will be enrolled/assessed up to three months post-injury.</time_frame>
    <description>To compare functional outcomes in pelvic ring injury patients who are treated nonoperatively and receive intranasal salmon calcitonin with those who do not receive intranasal salmon calcitonin. The activity will be tested by the below measure:&#xD;
Iowa Pelvic Score is pelvic injury-specific assessment comprising six items: activities of daily life, work history, pain, limping, visual pain line (visual analogue scale) and cosmesis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess function and activity in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin</measure>
    <time_frame>The subject will be enrolled/assessed up to three months post-injury.</time_frame>
    <description>To determine if intranasal salmon calcitonin has any effect on overall health compared to those who do not receive intranasal salmon calcitonin. The activity will be tested by the below measure:&#xD;
SF-36 Short Form Health Survey is a measure of health-related quality-of-life questions. For example; in general, would you say your health is: Excellent, Very Good, Good, Fair, Poor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess mobility in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin</measure>
    <time_frame>The subject will be enrolled/assessed up to three months post-injury.</time_frame>
    <description>To determine if intranasal salmon calcitonin improves a person's mobility compared to those who do not receive intranasal salmon calcitonin. The activity will be tested by the below measure:&#xD;
Timed Up and Go test (TUG) is a simple test used to assess a person's mobility. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic healing using intranasal salmon calcitonin</measure>
    <time_frame>The subject will be enrolled/assessed up to three months post-injury.</time_frame>
    <description>To compare radiographic healing using AP/inlet and outlet pelvic x-rays on geriatric patients with pelvic ring injuries who receive intranasal salmon calcitonin and with those who do not receive intranasal salmon calcitonin.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Pelvic Ring Fractures</condition>
  <arm_group>
    <arm_group_label>Non-Treatment Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This is the Non-Treatment Arm of the study. No intervention is to be administered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Miacalcin Calcitonin Salmon Nasal Spray</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 spray (200 IU) qDay, alternate nostrils daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Miacalcin Calcitonin Salmon Nasal Spray</intervention_name>
    <description>Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily</description>
    <arm_group_label>Miacalcin Calcitonin Salmon Nasal Spray</arm_group_label>
    <other_name>Miacalcin</other_name>
    <other_name>Calcitonin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        •Males or females over the age of 65 who sustain isolated pelvic ring injuries via a&#xD;
        low-energy mechanism&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An open pelvic ring fracture&#xD;
&#xD;
          -  Concomitant acetabular fracture&#xD;
&#xD;
          -  They are on ISC prior to enrollment&#xD;
&#xD;
          -  Allergic or have contraindications to calcitonin or salmon&#xD;
&#xD;
          -  Sustain other injuries in their spine or lower extremities&#xD;
&#xD;
          -  Unwilling to participate in the study&#xD;
&#xD;
          -  Nonambulatory at baseline&#xD;
&#xD;
          -  Neurologic deficit associated with the pelvic ring injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brett Crist, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri-Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Missouri Health System</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>March 19, 2023</last_update_submitted>
  <last_update_submitted_qc>March 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Missouri-Columbia</investigator_affiliation>
    <investigator_full_name>Brett Crist</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcitonin</mesh_term>
    <mesh_term>Salmon calcitonin</mesh_term>
    <mesh_term>Calcitonin Gene-Related Peptide</mesh_term>
    <mesh_term>Katacalcin</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/NCT03812991
org study id: 2013172
nct id: NCT03812991
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Pelvic ring fractures in the geriatric population are a rising problem for surgeons in
      industrialized countries. Many of these low-energy fractures are treated nonoperatively;
      however, pain is a significant factor in recovery of these patients and often inhibits their
      ability to mobilize. Most of these fractures are lateral compression type 1 injuries which
      are defined as an impaction to the sacrum with varying amounts of anterior/pubic root/rami
      fractures. Many of these patients in the geriatric population suffer from osteoporosis and
      the injuries are often sustained from a low-energy mechanism like a fall. The tenet of
      treatment for all osteoporotic fractures is early mobilization. It is well known that
      extended periods of bed rest will lead to pneumonia, decubitus ulceration, deep venous
      thrombosis, and, in the case of the pelvis, not prevent subsequent deformity. Calcitonin is a
      polypeptide containing 32 amino acids, and it plays a role in the regulation of bone
      metabolism as a hormone that prevents bone resorption. Intranasal salmon calcitonin (ISC) has
      been demonstrated to decrease pain and improve the level of activity in patients with acute
      vertebral osteoporotic compression fractures when administered within the first 5 days of
      onset of pain/injury. It has also demonstrated an immediate post analgesic effect in
      osteoporotic distal radius fractures treated nonoperatively. The antihyperalgesic action of
      calcitonin appears to be mediated by serotonin receptors. The purpose of this study is to
      evaluate the analgesic effect of ISC on geriatric patients with pelvic ring injuries who are
      treated nonoperatively.
Baseline: Treatment group will be prescribed 200IU of ISC daily for a period of 3 months. The
      control group will not be prescribed calcitonin. Participants will complete research only
      Iowa pelvis score questionnaire, SF-36 questionnaire and visual analogue scale (VAS) to
      assess subjective pain and function. Two-week follow up visit post discharge: participants
      will complete Iowa pelvis score questionnaire, SF-36 questionnaire and VAS to assess
      subjective pain and function. Participants will be referred for a standard of care DEXA bone
      density scan if they have no previous diagnosis of osteoporosis and no history of previous
      scan within a year. Six weeks post discharge: participants will complete Iowa pelvis score
      questionnaire, SF-36 questionnaire and VAS to assess subjective pain and function.
      Participants will undergo standard of care radiographic analysis of pelvic ring injury with
      AP/inlet and outlet pelvic x-rays 4. Twelve weeks post discharge: Participants will complete
      Iowa pelvis score questionnaire, SF-36 questionnaire and VAS to assess subjective pain and
      function. Participants will undergo standard of care radiographic analysis of pelvic ring
      injury with AP/inlet and outlet pelvic x-rays - Participants will perform a timed up and go
      (TUG) test.

      After informed consent is obtained, all patients who meet eligibility criteria will be
      randomized into one of two groups. Randomization will be achieved by numbering 50 sealed
      white envelopes (25 control, 25 treatment). There is no blinding to the randomization. It
      would be difficult to blind the participants, or the research personnel. We do not believe
      there will be any significant bias that can be corrected with blinding.

      Treatment: 200IUof ISC daily for a period of 3 month

      Control: Will not be prescribed calcitonin (ISC)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Concentration of acute pain in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin
time frame: The subject will be enrolled/assessed up to three months post-injury.
description: Compare acute pain using (Visual Analogue Scale; 0-10; 0=no pain; 10= worst pain imaginable) over a three-month period in geriatric patients with pelvic ring injuries who receive intranasal salmon calcitonin with those who do not receive intranasal salmon calcitonin.
measure: Evaluate functional outcomes in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin
time frame: The subject will be enrolled/assessed up to three months post-injury.
description: To compare functional outcomes in pelvic ring injury patients who are treated nonoperatively and receive intranasal salmon calcitonin with those who do not receive intranasal salmon calcitonin. The activity will be tested by the below measure:
Iowa Pelvic Score is pelvic injury-specific assessment comprising six items: activities of daily life, work history, pain, limping, visual pain line (visual analogue scale) and cosmesis.
measure: Assess function and activity in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin
time frame: The subject will be enrolled/assessed up to three months post-injury.
description: To determine if intranasal salmon calcitonin has any effect on overall health compared to those who do not receive intranasal salmon calcitonin. The activity will be tested by the below measure:
SF-36 Short Form Health Survey is a measure of health-related quality-of-life questions. For example; in general, would you say your health is: Excellent, Very Good, Good, Fair, Poor.
measure: Assess mobility in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin
time frame: The subject will be enrolled/assessed up to three months post-injury.
description: To determine if intranasal salmon calcitonin improves a person's mobility compared to those who do not receive intranasal salmon calcitonin. The activity will be tested by the below measure:
Timed Up and Go test (TUG) is a simple test used to assess a person's mobility. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
measure: Radiographic healing using intranasal salmon calcitonin
time frame: The subject will be enrolled/assessed up to three months post-injury.
description: To compare radiographic healing using AP/inlet and outlet pelvic x-rays on geriatric patients with pelvic ring injuries who receive intranasal salmon calcitonin and with those who do not receive intranasal salmon calcitonin.
arm group label: Non-Treatment Group
arm group type: No Intervention
description: This is the Non-Treatment Arm of the study. No intervention is to be administered.
arm group label: Miacalcin Calcitonin Salmon Nasal Spray
arm group type: Experimental
description: 1 spray (200 IU) qDay, alternate nostrils daily
intervention type: Drug
intervention name: Miacalcin Calcitonin Salmon Nasal Spray
description: Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily
arm group label: Miacalcin Calcitonin Salmon Nasal Spray
other name: Miacalcin
other name: Calcitonin
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Brett Crist, MD
role: Principal Investigator
affiliation: University of Missouri-Columbia
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Missouri-Columbia
investigator full name: Brett Crist
investigator title: Associate Professor
mesh term: Calcitonin
mesh term: Salmon calcitonin
mesh term: Calcitonin Gene-Related Peptide
mesh term: Katacalcin