<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/NCT04473989</url>
  </required_header>
  <id_info>
    <org_study_id>M2020207</org_study_id>
    <nct_id>NCT04473989</nct_id>
  </id_info>
  <brief_title>Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture</brief_title>
  <official_title>The Effect of Weekly Injection of Teriparatide on the Healing of Distal Radius Fracture in a Double-blind, Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</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>
      The purpose of this study is to examine the effect of weekly dosing strategy on fracture&#xD;
      healing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 1, 2021</start_date>
  <completion_date type="Anticipated">June 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The median time of radiographic healing</measure>
    <time_frame>0-14 weeks</time_frame>
    <description>A score of 13 by Modified Radiographic Union Scale for Tibia fractures (mRUST) scoring system would provide a confident assessment of union</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-Rated Wrist Evaluation</measure>
    <time_frame>0, 4, 6, 8, 10, 12, 14 and 16 weeks</time_frame>
    <description>A 15-item questionnaire(PRWE) that rates wrist-related pain and disability in functional activities. The scores range from 0 (no disability) to 100 (severest disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength</measure>
    <time_frame>6, 8, 10, 12, 14, and 16 weeks</time_frame>
    <description>Grip strength will be assessed by a dynamometer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Colles' Fracture</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Injection product without active teriparatide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PTH 40ug/w</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Injection product with active teriparatide</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>recombinant teriparatide for injection</intervention_name>
    <description>weekly subcutaneous administration of 40 ug</description>
    <arm_group_label>PTH 40ug/w</arm_group_label>
    <other_name>Xinfutai</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>weekly subcutaneous administration of 40 ug</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Xinfutai placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Postmenopausal women aged 45-75 (at least 2 years after menopause)&#xD;
&#xD;
          2. With primary osteoporosis&#xD;
&#xD;
          3. Patients with Colles fractures with a fracture time of no more than 7 days&#xD;
&#xD;
          4. conservative treatment after fracture (closed reduction and immobilization)&#xD;
&#xD;
          5. no multiple fractures&#xD;
&#xD;
          6. Informed well and agree to participate in this clinical trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Combine other physical diseases, including diabetes, severe hypertension, autoimmune&#xD;
             diseases, heart, liver and kidney diseases, malignant tumors, mental illnesses, and&#xD;
             other diseases that doctors believe may affect the healing process.&#xD;
&#xD;
          2. In addition to primary osteoporosis, any disease affecting bone metabolism or&#xD;
             treatment response, including serum PTH&gt;65pg/ml, 25-hydroxyvitamin D&lt;20ng/ml, alkaline&#xD;
             phosphatase&gt;135U/L, history of bone tumor, Paget disease, history of radiotherapy&#xD;
&#xD;
          3. The fracture site has a history of trauma or surgery, affecting the function of the&#xD;
             wrist or forearm&#xD;
&#xD;
          4. Those who are allergic to PTH or any excipients&#xD;
&#xD;
          5. Currently receiving anti-osteoporosis treatment or receiving other anti-osteoporosis&#xD;
             treatment during the trial&#xD;
&#xD;
          6. Contraindication of teriparatide including hyperparathyroidism, severe renal&#xD;
             insufficiency, hypercalcemia, etc.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Postmenopausal women</gender_description>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chunli Song, M.D.; Ph. D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Junxiong Zhu, M.D.</last_name>
    <phone>+86 18801238160</phone>
    <email>zhujunxiong@bjmu.edu.cn</email>
  </overall_contact>
  <reference>
    <citation>Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731.</citation>
    <PMID>19594305</PMID>
  </reference>
  <reference>
    <citation>Ebata S, Takahashi J, Hasegawa T, Mukaiyama K, Isogai Y, Ohba T, Shibata Y, Ojima T, Yamagata Z, Matsuyama Y, Haro H. Role of Weekly Teriparatide Administration in Osseous Union Enhancement within Six Months After Posterior or Transforaminal Lumbar Interbody Fusion for Osteoporosis-Associated Lumbar Degenerative Disorders: A Multicenter, Prospective Randomized Study. J Bone Joint Surg Am. 2017 Mar 1;99(5):365-372. doi: 10.2106/JBJS.16.00230.</citation>
    <PMID>28244906</PMID>
  </reference>
  <reference>
    <citation>Zhang W, Zhu J, Ma T, Liu C, Hai B, Du G, Wang H, Li N, Leng H, Xu Y, Song C. Comparison of the effects of once-weekly and once-daily rhPTH (1-34) injections on promoting fracture healing in rodents. J Orthop Res. 2018 Apr;36(4):1145-1152. doi: 10.1002/jor.23750. Epub 2017 Nov 20.</citation>
    <PMID>28960481</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 12, 2020</last_update_submitted>
  <last_update_submitted_qc>July 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</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>Colles' Fracture</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Radius Fractures</mesh_term>
    <mesh_term>Wrist Fractures</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/NCT04473989
org study id: M2020207
nct id: NCT04473989
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the effect of weekly dosing strategy on fracture
      healing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: The median time of radiographic healing
time frame: 0-14 weeks
description: A score of 13 by Modified Radiographic Union Scale for Tibia fractures (mRUST) scoring system would provide a confident assessment of union
measure: Patient-Rated Wrist Evaluation
time frame: 0, 4, 6, 8, 10, 12, 14 and 16 weeks
description: A 15-item questionnaire(PRWE) that rates wrist-related pain and disability in functional activities. The scores range from 0 (no disability) to 100 (severest disability).
measure: Grip strength
time frame: 6, 8, 10, 12, 14, and 16 weeks
description: Grip strength will be assessed by a dynamometer.
arm group label: Placebo
arm group type: Placebo Comparator
description: Injection product without active teriparatide
arm group label: PTH 40ug/w
arm group type: Experimental
description: Injection product with active teriparatide
intervention type: Drug
intervention name: recombinant teriparatide for injection
description: weekly subcutaneous administration of 40 ug
arm group label: PTH 40ug/w
other name: Xinfutai
intervention type: Drug
intervention name: Placebo
description: weekly subcutaneous administration of 40 ug
arm group label: Placebo
other name: Xinfutai placebo
criteria: 
gender: Female
gender based: Yes
gender description: Postmenopausal women
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chunli Song, M.D.; Ph. D.
role: Principal Investigator
affiliation: Peking University Third Hospital
last name: Junxiong Zhu, M.D.
phone: +86 18801238160
email: zhujunxiong@bjmu.edu.cn
citation: Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731.
PMID: 19594305
citation: Ebata S, Takahashi J, Hasegawa T, Mukaiyama K, Isogai Y, Ohba T, Shibata Y, Ojima T, Yamagata Z, Matsuyama Y, Haro H. Role of Weekly Teriparatide Administration in Osseous Union Enhancement within Six Months After Posterior or Transforaminal Lumbar Interbody Fusion for Osteoporosis-Associated Lumbar Degenerative Disorders: A Multicenter, Prospective Randomized Study. J Bone Joint Surg Am. 2017 Mar 1;99(5):365-372. doi: 10.2106/JBJS.16.00230.
PMID: 28244906
citation: Zhang W, Zhu J, Ma T, Liu C, Hai B, Du G, Wang H, Li N, Leng H, Xu Y, Song C. Comparison of the effects of once-weekly and once-daily rhPTH (1-34) injections on promoting fracture healing in rodents. J Orthop Res. 2018 Apr;36(4):1145-1152. doi: 10.1002/jor.23750. Epub 2017 Nov 20.
PMID: 28960481
responsible party type: Sponsor
mesh term: Colles' Fracture
mesh term: Fractures, Bone
mesh term: Radius Fractures
mesh term: Wrist Fractures
mesh term: Teriparatide
sharing ipd: No