<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/NCT02249741</url>
  </required_header>
  <id_info>
    <org_study_id>Gastro-2012-RB-1</org_study_id>
    <nct_id>NCT02249741</nct_id>
  </id_info>
  <brief_title>Prospective Study of Profile of Hepatic Osteodystrophy in Patients With Non-Choleastatic Liver Cirrhosis and Impact of Bisphosphonate Supplementation</brief_title>
  <official_title>PROSPECTIVE STUDY OF PROFILE OF HEPATIC OSTEODYSTROPHY IN PATIENTS WITH NON-CHOLEASTATIC LIVER CIRRHOSIS AND IMPACT OF BISPHOSPHONATE SUPPLEMENTATION</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Ashish Kumar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sir Ganga Ram Hospital</source>
  <brief_summary>
    <textblock>
      Background and Objectives: Patients with liver cirrhosis are more prone to develop reduced&#xD;
      bone mineral density i.e. hepatic osteodystrophy (HOD). It includes both osteopenia and&#xD;
      osteoporosis and may lead to increased fracture risks. There is scanty data on prevalence of&#xD;
      HOD in Indian population and its treatment outcome. The investigators aimed to determine&#xD;
      prevalence of HOD, factors associated with it and the impact of bisphosphonates on bone&#xD;
      mineral density in patients with liver cirrhosis.&#xD;
&#xD;
      Patients and Methods: Consecutive patients with liver cirrhosis admitted at Sir Ganga Ram&#xD;
      Hospital, New Delhi between August 2012 and July 2013 were enrolled. Patients with chronic&#xD;
      kidney disease, hyperparathyroidism and those on steroids were excluded. Bone mineral density&#xD;
      (BMD) was measured by dual-energy X-ray absorptiometry (DEXA) at the lumbar spine and femoral&#xD;
      neck. Osteopenia and osteoporosis were defined according to WHO criteria. All patients also&#xD;
      underwent 25-hydroxy-vitamin-D, sex hormone (testosterone in male and LH and Estradiol in&#xD;
      female) and parathyroid hormone (PTH) along with routine investigations. Transient&#xD;
      elastography was also done in all patients. Ibandronic acid 150 mg per day orally for six&#xD;
      months was given in patients with osteoporosis and DEXA scan repeated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>Phase 4</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>Improvement in Bone Mineral Density on DEXA scan</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of new fractures</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Cirrhosis</condition>
  <arm_group>
    <arm_group_label>Patients with osteoporosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treated with Ibandronic acid as per protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treated with Ibandronic acid as per protocol</intervention_name>
    <description>treated with Ibandronic acid at a dose of 150 mg once a month for six months</description>
    <arm_group_label>Patients with osteoporosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Liver Cirrhosis&#xD;
&#xD;
          2. Age 18-70 years&#xD;
&#xD;
          3. Informed and written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Chronic renal failure&#xD;
&#xD;
          2. Prolonged steroid use more than 3 months&#xD;
&#xD;
          3. Patients on immunosuppressive therapy&#xD;
&#xD;
          4. Primary hyperparathyroidism&#xD;
&#xD;
          5. Post menopausal women&#xD;
&#xD;
          6. Pregnancy&#xD;
&#xD;
          7. Cushing's syndrome&#xD;
&#xD;
          8. Malignancy&#xD;
&#xD;
          9. HIV Co-infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Gastroenterology &amp; Hepatology, Sir Ganga Ram Hospital</name>
      <address>
        <city>New Delhi</city>
        <zip>110060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 25, 2014</last_update_submitted>
  <last_update_submitted_qc>September 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sir Ganga Ram Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Ashish Kumar</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ibandronic Acid</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02249741
org study id: Gastro-2012-RB-1
nct id: NCT02249741
lead sponsor: 
Background and Objectives: Patients with liver cirrhosis are more prone to develop reduced
      bone mineral density i.e. hepatic osteodystrophy (HOD). It includes both osteopenia and
      osteoporosis and may lead to increased fracture risks. There is scanty data on prevalence of
      HOD in Indian population and its treatment outcome. The investigators aimed to determine
      prevalence of HOD, factors associated with it and the impact of bisphosphonates on bone
      mineral density in patients with liver cirrhosis.

      Patients and Methods: Consecutive patients with liver cirrhosis admitted at Sir Ganga Ram
      Hospital, New Delhi between August 2012 and July 2013 were enrolled. Patients with chronic
      kidney disease, hyperparathyroidism and those on steroids were excluded. Bone mineral density
      (BMD) was measured by dual-energy X-ray absorptiometry (DEXA) at the lumbar spine and femoral
      neck. Osteopenia and osteoporosis were defined according to WHO criteria. All patients also
      underwent 25-hydroxy-vitamin-D, sex hormone (testosterone in male and LH and Estradiol in
      female) and parathyroid hormone (PTH) along with routine investigations. Transient
      elastography was also done in all patients. Ibandronic acid 150 mg per day orally for six
      months was given in patients with osteoporosis and DEXA scan repeated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in Bone Mineral Density on DEXA scan
time frame: 6 months
measure: Incidence of new fractures
time frame: 6 months
arm group label: Patients with osteoporosis
arm group type: Experimental
description: Treated with Ibandronic acid as per protocol
intervention type: Drug
intervention name: Treated with Ibandronic acid as per protocol
description: treated with Ibandronic acid at a dose of 150 mg once a month for six months
arm group label: Patients with osteoporosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: India
responsible party type: Sponsor-Investigator
investigator affiliation: Sir Ganga Ram Hospital
investigator full name: Dr. Ashish Kumar
investigator title: Associate Professor
mesh term: Liver Cirrhosis
mesh term: Fibrosis
mesh term: Ibandronic Acid