<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/NCT03002428</url>
  </required_header>
  <id_info>
    <org_study_id>PF708-301</org_study_id>
    <nct_id>NCT03002428</nct_id>
  </id_info>
  <brief_title>A Comparison of PF708 and Forteo in Osteoporosis Patients</brief_title>
  <official_title>A Randomized Study Comparing the Effects of PF708 and Forteo in Patients With Osteoporosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfenex, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfenex, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effects of two teriparatide products, PF708 and&#xD;
      Forteo, in patients with osteoporosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, multi-center study conducted in the United States. Men and women with&#xD;
      osteoporosis will be enrolled in a parallel-group, open-label study design to compare the&#xD;
      effects of PF708 and Forteo after 24 weeks of treatment. Half of the subjects will be&#xD;
      randomized to receive PF708, and the other half will be randomized to receive Forteo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</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>Blood levels of anti-drug antibody (ADA) against teriparatide</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean percentage change in lumbar-spine bone mineral density (BMD)</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median percentage change in serum N-terminal propeptide of type 1 procollagen (P1NP)</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median percentage change in serum crosslinked C-terminal telopeptide of type 1 collagen (CTX)</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma maximum concentration (Cmax) of teriparatide</measure>
    <time_frame>4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma area-under-the-curve (AUC) of teriparatide</measure>
    <time_frame>4 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">181</enrollment>
  <condition>Osteoporosis</condition>
  <arm_group>
    <arm_group_label>Teriparatide (PF708)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PF708 20 mcg once-daily subcutaneous injection for 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Teriparatide (Forteo)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Forteo 20 mcg once-daily subcutaneous injection for 24 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teriparatide (PF708)</intervention_name>
    <description>Subcutaneous injection</description>
    <arm_group_label>Teriparatide (PF708)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teriparatide (Forteo)</intervention_name>
    <description>Subcutaneous injection</description>
    <arm_group_label>Teriparatide (Forteo)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  If female, ≥5 years postmenopausal at the time of screening, with a DXA-derived BMD&#xD;
             value at least 1 standard deviation (SD) below the average of young, healthy women&#xD;
&#xD;
          -  If male, has a DXA-derived BMD value at least 2 SD below the average of young, healthy&#xD;
             men&#xD;
&#xD;
          -  Able to use the pen injection device correctly&#xD;
&#xD;
          -  Able to understand and sign the written Informed Consent Form (ICF)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with oral bisphosphonates (once daily or once weekly) within 6 months of&#xD;
             screening&#xD;
&#xD;
          -  Any current or prior human PTH-derived products (e.g., Forteo, Teribone, Natpara),&#xD;
             including for investigational purposes&#xD;
&#xD;
          -  Immobility due to severe or chronically disabling conditions (e.g., stroke,&#xD;
             Parkinson's disease, multiple sclerosis)&#xD;
&#xD;
          -  History of metabolic bone diseases other than osteoporosis&#xD;
&#xD;
          -  History of malignant disease, including solid tumors and hematologic malignancies&#xD;
             (except basal cell and squamous cell carcinomas of the skin that have been completely&#xD;
             excised and are considered cured)&#xD;
&#xD;
          -  History of Paget's disease of bone&#xD;
&#xD;
          -  History of prior external beam or implant radiation therapy involving the skeleton&#xD;
&#xD;
          -  Active urolithiasis or primary hyperparathyroidism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hubert C Chen, MD</last_name>
    <role>Study Director</role>
    <affiliation>Pfenex, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Orthopaedic Group</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SunValley Arthritis Center</name>
      <address>
        <city>Peoria</city>
        <state>Arizona</state>
        <zip>85381</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OB-GYN Associates of Mid-Florida</name>
      <address>
        <city>Leesburg</city>
        <state>Florida</state>
        <zip>34748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Research Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30319</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Bridgeton</city>
        <state>Missouri</state>
        <zip>63044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Papillion</city>
        <state>Nebraska</state>
        <zip>68046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Mexico Clinical Research &amp; Osteoporosis Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lillestol Research</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44311</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altoona Center for Clinical Research</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pennsylvania Regional Center for Arthritis &amp; Osteoporosis Research</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Medical</name>
      <address>
        <city>Danville</city>
        <state>Virginia</state>
        <zip>24541</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Puyallup</city>
        <state>Washington</state>
        <zip>98372</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>May 21, 2018</last_update_submitted>
  <last_update_submitted_qc>May 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03002428
org study id: PF708-301
nct id: NCT03002428
lead sponsor: 
has dmc: No
The purpose of this study is to compare the effects of two teriparatide products, PF708 and
      Forteo, in patients with osteoporosis.
This is a randomized, multi-center study conducted in the United States. Men and women with
      osteoporosis will be enrolled in a parallel-group, open-label study design to compare the
      effects of PF708 and Forteo after 24 weeks of treatment. Half of the subjects will be
      randomized to receive PF708, and the other half will be randomized to receive Forteo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Blood levels of anti-drug antibody (ADA) against teriparatide
time frame: 24 weeks
measure: Mean percentage change in lumbar-spine bone mineral density (BMD)
time frame: 24 weeks
measure: Median percentage change in serum N-terminal propeptide of type 1 procollagen (P1NP)
time frame: 24 weeks
measure: Median percentage change in serum crosslinked C-terminal telopeptide of type 1 collagen (CTX)
time frame: 24 weeks
measure: Plasma maximum concentration (Cmax) of teriparatide
time frame: 4 hours
measure: Plasma area-under-the-curve (AUC) of teriparatide
time frame: 4 hours
arm group label: Teriparatide (PF708)
arm group type: Experimental
description: PF708 20 mcg once-daily subcutaneous injection for 24 weeks
arm group label: Teriparatide (Forteo)
arm group type: Active Comparator
description: Forteo 20 mcg once-daily subcutaneous injection for 24 weeks
intervention type: Drug
intervention name: Teriparatide (PF708)
description: Subcutaneous injection
arm group label: Teriparatide (PF708)
intervention type: Drug
intervention name: Teriparatide (Forteo)
description: Subcutaneous injection
arm group label: Teriparatide (Forteo)
criteria: 
gender: All
minimum age: 30 Years
maximum age: 85 Years
healthy volunteers: No
last name: Hubert C Chen, MD
role: Study Director
affiliation: Pfenex, Inc
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country: United States
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Teriparatide
sharing ipd: No