<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/NCT03005678</url>
  </required_header>
  <id_info>
    <org_study_id>CREC/16</org_study_id>
    <nct_id>NCT03005678</nct_id>
  </id_info>
  <brief_title>Denosumab Versus Bisphosphonates (Alendronate) in GIOP</brief_title>
  <official_title>Denosumab Versus Oral Bisphosphonate (Alendronate) for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tuen Mun Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tuen Mun Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized controlled trial to compare for the efficacy and tolerability of denosumab and&#xD;
      oral alendronate in the management of glucocorticoid induced osteoporosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design: an open-label randomized controlled trial Duration of study: 12 months&#xD;
&#xD;
      Treatment arms:&#xD;
&#xD;
        1. Denosumab: a total of 2 doses in a period of 12 months&#xD;
&#xD;
        2. Oral alendronate: weekly dose in a period of 12 months Target sample size: 220 patients&#xD;
           (110 patients in each arm)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>bone mineral density at lumbar spine</measure>
    <time_frame>month 12</time_frame>
    <description>BMD lumbar spine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>bone mineral density at the hip</measure>
    <time_frame>month 12</time_frame>
    <description>BMD hip</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bone turnover markers</measure>
    <time_frame>month 12</time_frame>
    <description>P1NP and osteocalcin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>month 12</time_frame>
    <description>adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Osteoporosis</condition>
  <arm_group>
    <arm_group_label>Denosumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>denosumab subcutaneous 60mg every 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alendronate</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>alendronate 70mg orally every week</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Denosumab</intervention_name>
    <description>active treatment group</description>
    <arm_group_label>Denosumab</arm_group_label>
    <other_name>prolia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alendronate</intervention_name>
    <description>comparator</description>
    <arm_group_label>Alendronate</arm_group_label>
    <other_name>fosamax</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults (women or men) &gt;18 years of age&#xD;
&#xD;
          2. Receiving long-term prednisolone treatment for various medical illnesses, defined as a&#xD;
             daily prednisolone dose of ≥2.5mg/day for ≥12 months).&#xD;
&#xD;
          3. Informed consent from patients.&#xD;
&#xD;
          4. Willing to comply with all study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates,&#xD;
             strontium or other experimental anti-osteoporotic agents.&#xD;
&#xD;
          2. Premenopausal women who plan for pregnancy within 18 months of study entry.&#xD;
&#xD;
          3. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and&#xD;
             hyperparathyroidism.&#xD;
&#xD;
          4. Patients with unexplained hypocalcemia.&#xD;
&#xD;
          5. Patients with serum creatinine level of &gt;=200umol/L.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CC Mok</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Medicine, Tuen Mun Hospital</name>
      <address>
        <city>Hong Kong</city>
        <zip>000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tuen Mun Hospital</investigator_affiliation>
    <investigator_full_name>Chi Chiu Mok</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>glucocorticoids, steroids, osteoporosis</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>Denosumab</mesh_term>
    <mesh_term>Alendronate</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/NCT03005678
org study id: CREC/16
nct id: NCT03005678
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized controlled trial to compare for the efficacy and tolerability of denosumab and
      oral alendronate in the management of glucocorticoid induced osteoporosis
Study design: an open-label randomized controlled trial Duration of study: 12 months

      Treatment arms:

        1. Denosumab: a total of 2 doses in a period of 12 months

        2. Oral alendronate: weekly dose in a period of 12 months Target sample size: 220 patients
           (110 patients in each arm)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: bone mineral density at lumbar spine
time frame: month 12
description: BMD lumbar spine
measure: bone mineral density at the hip
time frame: month 12
description: BMD hip
measure: bone turnover markers
time frame: month 12
description: P1NP and osteocalcin
measure: adverse events
time frame: month 12
description: adverse events
arm group label: Denosumab
arm group type: Active Comparator
description: denosumab subcutaneous 60mg every 6 months
arm group label: Alendronate
arm group type: Placebo Comparator
description: alendronate 70mg orally every week
intervention type: Drug
intervention name: Denosumab
description: active treatment group
arm group label: Denosumab
other name: prolia
intervention type: Drug
intervention name: Alendronate
description: comparator
arm group label: Alendronate
other name: fosamax
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: CC Mok
role: Principal Investigator
affiliation: Principal Investigator
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tuen Mun Hospital
investigator full name: Chi Chiu Mok
investigator title: Principal investigator
mesh term: Osteoporosis
mesh term: Denosumab
mesh term: Alendronate
sharing ipd: No