<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/NCT03268356</url>
  </required_header>
  <id_info>
    <org_study_id>PST-HK-100.1</org_study_id>
    <nct_id>NCT03268356</nct_id>
  </id_info>
  <brief_title>STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture</brief_title>
  <official_title>Clinical Investigation of a Local Osteo-Enhancement Procedure's (LOEP) Ability to Strengthen the Contralateral Femur of Women After a Fragility Fracture of the Hip in Hong Kong</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AgNovos Healthcare, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AgNovos Healthcare, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</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>
      To evaluate the procedure and safety profile of the AGN1 Femoral LOEP Kit. This pilot study&#xD;
      will be used to evaluate AGN1 Femoral LOEP treatment in a contralateral proximal femur during&#xD;
      hip fracture repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research will be conducted as a prospective single-center study within Hong Kong. The&#xD;
      maximum number of subjects to be treated is twenty (20). This will be a non-randomized and&#xD;
      non-blinded study.&#xD;
&#xD;
      Subjects having had a fragility hip fracture on one side will be treated with LOEP in the&#xD;
      contralateral non-fractured proximal femur in the same operative session as the surgical&#xD;
      repair of the fractured hip. A fragility fracture is defined as a fracture resulting from a&#xD;
      fall from standing height.&#xD;
&#xD;
      All subjects will undergo hip fracture repair as recommended by the treating orthopedic&#xD;
      surgeon. Repair may include nailing, plates, screws and hip prosthesis.&#xD;
&#xD;
      Subjects may continue to receive, or when appropriate, can be commenced on a treatment regime&#xD;
      for osteoporosis. This decision will be made by the treating physician who will determine the&#xD;
      best course of action for each patient. The outcome of this decision will have not affect the&#xD;
      patient's eligibility for this trial.&#xD;
&#xD;
      Follow-up visits will be conducted at three (3) months, six (6) months, twelve (12) months,&#xD;
      and twenty-four (24) months after the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment or Device Emergent Serious Adverse Events</measure>
    <time_frame>24 Months</time_frame>
    <description>Incidence of all serious adverse events (SAEs) occurring from the day of procedure through the twenty-four (24) month follow-up period determined to be definitely related to Femoral LOEP and/or the AGN1 device.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Non-Treatment Emergent Fragility Fractures</measure>
    <time_frame>24 Months</time_frame>
    <description>Incidence of fragility fractures unrelated to the device or procedure occurring during the follow-up period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment or Device Emergent Adverse Events</measure>
    <time_frame>24 Months</time_frame>
    <description>Incidence of all adverse events occurring from the day of procedure through the twenty-four (24) month follow-up determined to be definitely related to Femoral LOEP and/or the AGN1 device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Bone Mineral Density between Baseline and 12 Months</measure>
    <time_frame>12 Months</time_frame>
    <description>Evaluation of bone mineral density (BMD) post-procedure at twelve (12) months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Bone Mineral Density between Baseline and 24 Months</measure>
    <time_frame>24 Months</time_frame>
    <description>Evaluation of bone mineral density (BMD) post-procedure at twenty-four (24) months.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Hip Fractures</condition>
  <condition>Osteoporosis, Postmenopausal</condition>
  <arm_group>
    <arm_group_label>AGN1 Treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects who have suffered a fragility hip fracture in one hip, sign the consent form and meet the inclusion and none of the exclusion of the study will receive the AGN1 Femoral Local Osteo-Enhancement Procedure (LOEP™) in the non-fractured hip.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AGN1 Femoral Local Osteo-Enhancement Procedure Kit</intervention_name>
    <description>A procedure that is intended to replace lost bone and increase the strength of the proximal femur in individuals with osteoporosis of the femoral neck.</description>
    <arm_group_label>AGN1 Treatment</arm_group_label>
    <other_name>AGN1 Femoral LOEP™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is a postmenopausal female&#xD;
&#xD;
          2. Subject has a low-energy fragility hip fracture in one hip and will undergo surgical&#xD;
             repair of the fractured hip.&#xD;
&#xD;
          3. Subject is ≥ 65 years of age.&#xD;
&#xD;
          4. Subject has willingness, ability, and commitment to participate in baseline and&#xD;
             follow-up evaluations for the full duration of the study.&#xD;
&#xD;
          5. Subject is capable of giving written informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has a prior diagnosis of secondary osteoporosis.&#xD;
&#xD;
          2. Subject has history of any hip surgery or previous hip fracture in the non-fractured&#xD;
             hip.&#xD;
&#xD;
          3. Subject has progressive increase in undiagnosed hip pain over the previous six (6)&#xD;
             months that in the opinion of the Investigator may suggest other underlying bone or&#xD;
             joint pathology (e.g. osteoarthritis, fracture, etc.).&#xD;
&#xD;
          4. Subject has serum calcium levels outside the normal lab range as per local guidelines&#xD;
             and reference ranges.&#xD;
&#xD;
          5. Subject has moderate to severe renal insufficiency as per local guidelines and&#xD;
             reference ranges.&#xD;
&#xD;
          6. Subject has insulin-dependent diabetes mellitus (IDDM).&#xD;
&#xD;
          7. Subject has Body Mass Index (BMI) &gt; 30.&#xD;
&#xD;
          8. Subject exhibits excessive smokeless tobacco use or excessive smoking as determined by&#xD;
             the principal investigator*.&#xD;
&#xD;
          9. Subject exhibits excessive alcohol consumption as determined by the principal&#xD;
             investigator*.&#xD;
&#xD;
         10. Subject has radiological evidence of gross bony or joint pathology of the&#xD;
             non-fractured hip.&#xD;
&#xD;
         11. Subject treated with corticosteroids or systemic glucocorticoids for ten (10) days in&#xD;
             the previous six (6) months.&#xD;
&#xD;
         12. Subject has history of oral or parenteral use of immune-suppressive drugs in the&#xD;
             previous twelve months.&#xD;
&#xD;
         13. Subject has history of metabolic bone disease other than osteoporosis (eg. Paget's&#xD;
             disease).&#xD;
&#xD;
         14. Subject has a history of auto-immune arthritic diseases including rheumatoid,&#xD;
             psoriatic, or those associated with systemic lupus erythematosus, spondyloarthropathy,&#xD;
             Reiter's Syndrome or Crohn's Disease.&#xD;
&#xD;
         15. Subject has a history of radiation therapy to the hip or pelvic region.&#xD;
&#xD;
         16. Subject has history of chemotherapy treatment for any condition within the previous&#xD;
             five years.&#xD;
&#xD;
         17. Subject has history of any diagnosis and treatment of malignancies (excluding basal&#xD;
             cell carcinoma) within the previous five years.&#xD;
&#xD;
         18. Subject has known allergies to implanted device.&#xD;
&#xD;
         19. Subject has severe comorbidity or poor general physical/mental health that, in the&#xD;
             opinion of the Investigator, will not allow the subject to be a good study candidate.&#xD;
&#xD;
         20. Subject is currently enrolled in another clinical study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Fang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Mary Hospital, Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Mary Hospital - Department of Orthopaedics and Traumatology</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <link>
    <url>http://www.agnovos.com</url>
    <description>Company website</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>November 28, 2022</last_update_submitted>
  <last_update_submitted_qc>November 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</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>
    <mesh_term>Osteoporosis, Postmenopausal</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
  </condition_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/NCT03268356
org study id: PST-HK-100.1
nct id: NCT03268356
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
To evaluate the procedure and safety profile of the AGN1 Femoral LOEP Kit. This pilot study
      will be used to evaluate AGN1 Femoral LOEP treatment in a contralateral proximal femur during
      hip fracture repair.
The research will be conducted as a prospective single-center study within Hong Kong. The
      maximum number of subjects to be treated is twenty (20). This will be a non-randomized and
      non-blinded study.

      Subjects having had a fragility hip fracture on one side will be treated with LOEP in the
      contralateral non-fractured proximal femur in the same operative session as the surgical
      repair of the fractured hip. A fragility fracture is defined as a fracture resulting from a
      fall from standing height.

      All subjects will undergo hip fracture repair as recommended by the treating orthopedic
      surgeon. Repair may include nailing, plates, screws and hip prosthesis.

      Subjects may continue to receive, or when appropriate, can be commenced on a treatment regime
      for osteoporosis. This decision will be made by the treating physician who will determine the
      best course of action for each patient. The outcome of this decision will have not affect the
      patient's eligibility for this trial.

      Follow-up visits will be conducted at three (3) months, six (6) months, twelve (12) months,
      and twenty-four (24) months after the procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Treatment or Device Emergent Serious Adverse Events
time frame: 24 Months
description: Incidence of all serious adverse events (SAEs) occurring from the day of procedure through the twenty-four (24) month follow-up period determined to be definitely related to Femoral LOEP and/or the AGN1 device.
measure: Incidence of Non-Treatment Emergent Fragility Fractures
time frame: 24 Months
description: Incidence of fragility fractures unrelated to the device or procedure occurring during the follow-up period.
measure: Incidence of Treatment or Device Emergent Adverse Events
time frame: 24 Months
description: Incidence of all adverse events occurring from the day of procedure through the twenty-four (24) month follow-up determined to be definitely related to Femoral LOEP and/or the AGN1 device.
measure: Change in Bone Mineral Density between Baseline and 12 Months
time frame: 12 Months
description: Evaluation of bone mineral density (BMD) post-procedure at twelve (12) months.
measure: Change in Bone Mineral Density between Baseline and 24 Months
time frame: 24 Months
description: Evaluation of bone mineral density (BMD) post-procedure at twenty-four (24) months.
arm group label: AGN1 Treatment
arm group type: Other
description: Subjects who have suffered a fragility hip fracture in one hip, sign the consent form and meet the inclusion and none of the exclusion of the study will receive the AGN1 Femoral Local Osteo-Enhancement Procedure (LOEP™) in the non-fractured hip.
intervention type: Device
intervention name: AGN1 Femoral Local Osteo-Enhancement Procedure Kit
description: A procedure that is intended to replace lost bone and increase the strength of the proximal femur in individuals with osteoporosis of the femoral neck.
arm group label: AGN1 Treatment
other name: AGN1 Femoral LOEP™
criteria: 
gender: Female
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Christian Fang, MD
role: Principal Investigator
affiliation: Queen Mary Hospital, Hong Kong
facility: 
country: Hong Kong
url: http://www.agnovos.com
description: Company website
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Osteoporosis, Postmenopausal
mesh term: Fractures, Bone
mesh term: Hip Fractures
sharing ipd: No