<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/NCT02195895</url>
  </required_header>
  <id_info>
    <org_study_id>STU00083759</org_study_id>
    <nct_id>NCT02195895</nct_id>
  </id_info>
  <brief_title>Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide</brief_title>
  <official_title>12 Month Open-Label Extension Study of the Effect of Alendronate on Bone in People With Chronic SCI Previously Treated With Teriparatide</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if a year of alendronate treatment will maintain or&#xD;
      increase bone mass density (BMD) compared to baseline BMD values in people with chronic&#xD;
      spinal cord injury (SCI).&#xD;
&#xD;
      This study will also investigate 1) if alendronate therapy will increase bone strength in&#xD;
      people with chronic SCI, 2) the number of participants with adverse events from alendronate,&#xD;
      and 3) the effects of alendronate on serum markers of bone metabolism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This extension study will enroll individuals who have completed treatment in the parent&#xD;
      protocol &quot;Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone&#xD;
      Architecture in Chronic Spinal Cord Injury&quot; or in the teriparatide extension protocol. This&#xD;
      study will allow those individuals who previously received teriparatide to be treated for a&#xD;
      year with alendronate to maintain any bone they may have gained and to possibly increase bone&#xD;
      mass further. Termination of teriparatide is followed by bone loss if anti-resorptive therapy&#xD;
      is not initiated, so this approach is optimal for continued treatment of the current group of&#xD;
      participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Actual">August 5, 2016</completion_date>
  <primary_completion_date type="Actual">August 5, 2016</primary_completion_date>
  <phase>Phase 2</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>BMD of Total Hip by DXA</measure>
    <time_frame>12 months</time_frame>
    <description>The mean percent change in bone mineral density (BMD) of the hip after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>C-terminal Telopeptide (CTX)</measure>
    <time_frame>12 months</time_frame>
    <description>The mean percent change in C-terminal telopeptide (CTX) from baseline after 12 months of treatment. CTX is a bone marker found in blood serum and measures the rate of bone breakdown.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMD by DXA at the Lumbar Spine</measure>
    <time_frame>12 months</time_frame>
    <description>The mean percent change in bone mineral density (BMD) in the lumbar spine after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amino-terminal Propeptide of Type 1 Collagen (P1NP)</measure>
    <time_frame>12 months</time_frame>
    <description>The mean percent change in amino-terminal of type 1 collagen (P1NP) from baseline after 12 months of treatment. P1NP is a bone marker found in blood serum and provides information about how fast the body is making new bone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone-specific Alkaline Phosphatase (BSAP)</measure>
    <time_frame>12 months</time_frame>
    <description>The mean percent change in bone-specific alkaline phosphatase (BSAP) after 12 months of treatment. BSAP is a bone marker found in blood serum and measures the rate of bone breakdown.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Spinal Cord Injury</condition>
  <condition>Bone Loss</condition>
  <condition>Osteoporosis</condition>
  <arm_group>
    <arm_group_label>Alendronate, Calcium, Vitamin D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Weekly oral alendronate 70 mg for 12 months&#xD;
Supplements: 1000 mg Calcium and 1000 IU Vitamin D daily for 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alendronate</intervention_name>
    <description>Weekly oral alendronate 70 mg for 12 months</description>
    <arm_group_label>Alendronate, Calcium, Vitamin D</arm_group_label>
    <other_name>Alendronic acid</other_name>
    <other_name>Fosamax</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Calcium</intervention_name>
    <description>Daily oral 1000 mg Calcium</description>
    <arm_group_label>Alendronate, Calcium, Vitamin D</arm_group_label>
    <other_name>Calcium carbonate</other_name>
    <other_name>Antacid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>Daily oral 1000 IU</description>
    <arm_group_label>Alendronate, Calcium, Vitamin D</arm_group_label>
    <other_name>Vitamin D3</other_name>
    <other_name>Cholecalciferol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prior enrollment in protocol &quot;Effect of Teriparatide, Vibration and the Combination on&#xD;
             Bone Mass and Bone Architecture in Chronic Spinal Cord Injury&quot;, (NCT01225055).&#xD;
&#xD;
          -  Women of child-bearing potential and men must agree to use adequate contraception&#xD;
             (hormonal or barrier method of birth control; abstinence) prior to study entry, for&#xD;
             the duration of study participation, and for 90 days following completion of therapy.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individual with renal insufficiency (calculated creatinine clearance &lt; 30 ml/min).&#xD;
&#xD;
          -  Individuals who are not able to sit or stand upright for at least 30 minutes after&#xD;
             taking their medication.&#xD;
&#xD;
          -  Individuals with poor dental hygiene.&#xD;
&#xD;
          -  Individuals with esophageal abnormalities.&#xD;
&#xD;
          -  Individuals who are not able to tolerate alendronate treatment.&#xD;
&#xD;
          -  Individuals who will not be able to return for all study visits.&#xD;
&#xD;
          -  Patients may not be receiving any other investigational agents.&#xD;
&#xD;
          -  Other medical conditions that in the opinion of the investigator would preclude the&#xD;
             subject from completing the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas J Schnitzer, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University Feinberg School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</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>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <results_first_submitted>May 10, 2018</results_first_submitted>
  <results_first_submitted_qc>August 28, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 26, 2018</results_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Thomas J. Schnitzer</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Teriparatide</keyword>
  <keyword>Alendronate</keyword>
  <keyword>Alendronic Acid</keyword>
  <keyword>Osteoporosis</keyword>
  <keyword>Bone Fracture</keyword>
  <keyword>Bone Loss</keyword>
  <keyword>Spinal Cord Injury</keyword>
  <keyword>Bone Diseases</keyword>
  <keyword>Metabolic Bone Diseases</keyword>
  <keyword>Musculoskeletal Diseases</keyword>
  <keyword>Spinal Cord Diseases</keyword>
  <keyword>Central Nervous System Diseases</keyword>
  <keyword>Nervous System Diseases</keyword>
  <keyword>Nervous System</keyword>
  <keyword>Wounds and Injuries</keyword>
  <keyword>Bone Density Conservation Agents</keyword>
  <keyword>Physiological Effects of Drugs</keyword>
  <keyword>Pharmacologic Actions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</mesh_term>
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Ergocalciferols</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Alendronate</mesh_term>
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Calcium Carbonate</mesh_term>
    <mesh_term>Antacids</mesh_term>
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Alendronate, Calcium, Vitamin D</title>
          <description>Drug: Weekly oral alendronate 70 mg for 12 months&#xD;
Supplements: Calcium and Vitamin D daily for 12 months&#xD;
Alendronate: Weekly oral alendronate 70 mg for 12 months&#xD;
Calcium: Daily Oral 1000 mg&#xD;
Vitamin D: Daily Oral 1000 IU</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Alendronate, Calcium, Vitamin D</title>
          <description>Drug: Weekly oral alendronate 70 mg for 12 months&#xD;
Supplements: Calcium and Vitamin D daily for 12 months&#xD;
Alendronate: Weekly oral alendronate 70 mg for 12 months&#xD;
Calcium: Daily Oral 1000 mg&#xD;
Vitamin D: Daily Oral 1000 IU</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.89" lower_limit="23.13" upper_limit="68.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>American Spinal Injury Association (ASIA) Impairment Scale</title>
          <description>ASIA impairment scale describes a person's functional impairment as a result of their spinal cord injury.&#xD;
A = Complete. No motor or sensory function in the lowest sacral spine segment (S4-5).&#xD;
B = Sensory Incomplete. Sensory function below the neurological level of injury (NLI) and in S4-S5, no motor function below NLI.&#xD;
C = Motor Incomplete. Motor function is preserved below NLI and more than half of the key muscle groups below NLI have a muscle grade &lt; 3.&#xD;
D = Motor Incomplete. Motor function is preserved below NLI and at least half of the key muscle groups below NLI have a muscle grade 3.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>ASIA A (Complete Injury)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ASIA B (Sensory Incomplete Injury)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ASIA C (Motor Incomplete Injury)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ASIA D (Motor Incomplete Injury)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>BMD of Total Hip by DXA</title>
        <description>The mean percent change in bone mineral density (BMD) of the hip after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Alendronate, Calcium, Vitamin D</title>
            <description>Drug: Weekly oral alendronate 70 mg for 12 months&#xD;
Supplements: Calcium and Vitamin D daily for 12 months&#xD;
Alendronate: Weekly oral alendronate 70 mg for 12 months&#xD;
Calcium: Daily Oral 1000 mg&#xD;
Vitamin D: Daily Oral 1000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>BMD of Total Hip by DXA</title>
          <description>The mean percent change in bone mineral density (BMD) of the hip after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams.</description>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.32" lower_limit="-1.1" upper_limit="3.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>C-terminal Telopeptide (CTX)</title>
        <description>The mean percent change in C-terminal telopeptide (CTX) from baseline after 12 months of treatment. CTX is a bone marker found in blood serum and measures the rate of bone breakdown.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Alendronate, Calcium, Vitamin D</title>
            <description>Drug: Weekly oral alendronate 70 mg for 12 months&#xD;
Supplements: Calcium and Vitamin D daily for 12 months&#xD;
Alendronate: Weekly oral alendronate 70 mg for 12 months&#xD;
Calcium: Daily Oral 1000 mg&#xD;
Vitamin D: Daily Oral 1000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>C-terminal Telopeptide (CTX)</title>
          <description>The mean percent change in C-terminal telopeptide (CTX) from baseline after 12 months of treatment. CTX is a bone marker found in blood serum and measures the rate of bone breakdown.</description>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-61.8" lower_limit="-99.8" upper_limit="-23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>BMD by DXA at the Lumbar Spine</title>
        <description>The mean percent change in bone mineral density (BMD) in the lumbar spine after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Alendronate, Calcium, Vitamin D</title>
            <description>Drug: Weekly oral alendronate 70 mg for 12 months&#xD;
Supplements: Calcium and Vitamin D daily for 12 months&#xD;
Alendronate: Weekly oral alendronate 70 mg for 12 months&#xD;
Calcium: Daily Oral 1000 mg&#xD;
Vitamin D: Daily Oral 1000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>BMD by DXA at the Lumbar Spine</title>
          <description>The mean percent change in bone mineral density (BMD) in the lumbar spine after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams.</description>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.54" lower_limit="0.17" upper_limit="4.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amino-terminal Propeptide of Type 1 Collagen (P1NP)</title>
        <description>The mean percent change in amino-terminal of type 1 collagen (P1NP) from baseline after 12 months of treatment. P1NP is a bone marker found in blood serum and provides information about how fast the body is making new bone.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Alendronate, Calcium, Vitamin D</title>
            <description>Drug: Weekly oral alendronate 70 mg for 12 months&#xD;
Supplements: Calcium and Vitamin D daily for 12 months&#xD;
Alendronate: Weekly oral alendronate 70 mg for 12 months&#xD;
Calcium: Daily Oral 1000 mg&#xD;
Vitamin D: Daily Oral 1000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>Amino-terminal Propeptide of Type 1 Collagen (P1NP)</title>
          <description>The mean percent change in amino-terminal of type 1 collagen (P1NP) from baseline after 12 months of treatment. P1NP is a bone marker found in blood serum and provides information about how fast the body is making new bone.</description>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-51.5" lower_limit="-93.8" upper_limit="-9.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bone-specific Alkaline Phosphatase (BSAP)</title>
        <description>The mean percent change in bone-specific alkaline phosphatase (BSAP) after 12 months of treatment. BSAP is a bone marker found in blood serum and measures the rate of bone breakdown.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Alendronate, Calcium, Vitamin D</title>
            <description>Drug: Weekly oral alendronate 70 mg for 12 months&#xD;
Supplements: Calcium and Vitamin D daily for 12 months&#xD;
Alendronate: Weekly oral alendronate 70 mg for 12 months&#xD;
Calcium: Daily Oral 1000 mg&#xD;
Vitamin D: Daily Oral 1000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>Bone-specific Alkaline Phosphatase (BSAP)</title>
          <description>The mean percent change in bone-specific alkaline phosphatase (BSAP) after 12 months of treatment. BSAP is a bone marker found in blood serum and measures the rate of bone breakdown.</description>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.5" lower_limit="-50.6" upper_limit="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Alendronate, Calcium, Vitamin D</title>
          <description>Drug: Weekly oral alendronate 70 mg for 12 months&#xD;
Supplements: Calcium and Vitamin D daily for 12 months&#xD;
Alendronate: Weekly oral alendronate 70 mg for 12 months&#xD;
Calcium: Daily Oral 1000 mg&#xD;
Vitamin D: Daily Oral 1000 IU</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Inferior Vena Cava (IVC) filter shifted</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Spinal cord cysts</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Infection (UTI)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Kidney stone</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <description>Secondary to Urinary Tract Infection</description>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pressure sore</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Bacteremia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Blood clot</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hypercholesterolemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye stye</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Worsened vision</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Loose tooth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cold</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Infection (MRSA)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <description>Lightheaded during blood draw</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Lower extremity fracture</sub_title>
                <description>Distal femoral fracture</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Ruptured stitches</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Heterotopic Ossification</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Soreness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Decrease sensation</sub_title>
                <description>Loss of sensation in left hand</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection (UTI)</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Abscess (perineal)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Cyst</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pressure sore</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Benign mass removal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Tooth extraction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Thomas Schnitzer</name_or_title>
      <organization>Northwestern University</organization>
      <phone>312-503-2315</phone>
      <email>tjs@northwestern.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02195895
org study id: STU00083759
nct id: NCT02195895
lead sponsor: 
has dmc: No
The purpose of this study is to determine if a year of alendronate treatment will maintain or
      increase bone mass density (BMD) compared to baseline BMD values in people with chronic
      spinal cord injury (SCI).

      This study will also investigate 1) if alendronate therapy will increase bone strength in
      people with chronic SCI, 2) the number of participants with adverse events from alendronate,
      and 3) the effects of alendronate on serum markers of bone metabolism.
This extension study will enroll individuals who have completed treatment in the parent
      protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone
      Architecture in Chronic Spinal Cord Injury" or in the teriparatide extension protocol. This
      study will allow those individuals who previously received teriparatide to be treated for a
      year with alendronate to maintain any bone they may have gained and to possibly increase bone
      mass further. Termination of teriparatide is followed by bone loss if anti-resorptive therapy
      is not initiated, so this approach is optimal for continued treatment of the current group of
      participants.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: BMD of Total Hip by DXA
time frame: 12 months
description: The mean percent change in bone mineral density (BMD) of the hip after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams.
measure: C-terminal Telopeptide (CTX)
time frame: 12 months
description: The mean percent change in C-terminal telopeptide (CTX) from baseline after 12 months of treatment. CTX is a bone marker found in blood serum and measures the rate of bone breakdown.
measure: BMD by DXA at the Lumbar Spine
time frame: 12 months
description: The mean percent change in bone mineral density (BMD) in the lumbar spine after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams.
measure: Amino-terminal Propeptide of Type 1 Collagen (P1NP)
time frame: 12 months
description: The mean percent change in amino-terminal of type 1 collagen (P1NP) from baseline after 12 months of treatment. P1NP is a bone marker found in blood serum and provides information about how fast the body is making new bone.
measure: Bone-specific Alkaline Phosphatase (BSAP)
time frame: 12 months
description: The mean percent change in bone-specific alkaline phosphatase (BSAP) after 12 months of treatment. BSAP is a bone marker found in blood serum and measures the rate of bone breakdown.
arm group label: Alendronate, Calcium, Vitamin D
arm group type: Experimental
description: Drug: Weekly oral alendronate 70 mg for 12 months
Supplements: 1000 mg Calcium and 1000 IU Vitamin D daily for 12 months
intervention type: Drug
intervention name: Alendronate
description: Weekly oral alendronate 70 mg for 12 months
arm group label: Alendronate, Calcium, Vitamin D
other name: Alendronic acid
other name: Fosamax
intervention type: Dietary Supplement
intervention name: Calcium
description: Daily oral 1000 mg Calcium
arm group label: Alendronate, Calcium, Vitamin D
other name: Calcium carbonate
other name: Antacid
intervention type: Dietary Supplement
intervention name: Vitamin D
description: Daily oral 1000 IU
arm group label: Alendronate, Calcium, Vitamin D
other name: Vitamin D3
other name: Cholecalciferol
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas J Schnitzer, MD, PhD
role: Principal Investigator
affiliation: Northwestern University Feinberg School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Thomas J. Schnitzer
investigator title: Professor
mesh term: Osteoporosis
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
mesh term: Calcium, Dietary
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Alendronate
mesh term: Vitamins
mesh term: Calcium Carbonate
mesh term: Antacids
mesh term: Calcium
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 