xml: <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/NCT06022237</url>
    </required_header>
    <id_info>
      <org_study_id>ILBS-Cirrhosis-61</org_study_id>
      <nct_id>NCT06022237</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Oral Ibandronate in Patients of Liver Cirrhosis With Hepatic Osteodystrophy.</brief_title>
    <official_title>Efficacy and Safety of Oral Ibandronate in Patients of Liver Cirrhosis With Hepatic Osteodystrophy: A Randomized, Double Blind, Placebo Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute of Liver and Biliary Sciences, India</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institute of Liver and Biliary Sciences, India</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>
        Hepatic osteodystrophy(HOD) is a common but frequently overlooked complication of liver&#xD;
        cirrhosis with a prevalence rate ranging from 13-70%. Bisphosphonates acting by inhibiting&#xD;
        bone resorption are frequently used. Intravenous infusions of bisphosphonates may cause&#xD;
        prolonged arthralgia and myalgia whereas oral bisphosphonates may cause digestive mucosal&#xD;
        damage causing dysphagia, esophagitis and ulcer. Such side effects have discouraged the&#xD;
        prescription of oral bisphosphonates for patients of cirrhosis mainly due to risk of upper GI&#xD;
        hemorrhage arising from esophageal variceal rupture.&#xD;
  &#xD;
        All studies done in past with bisphosphonates are either open labelled RCT/ non- randomized&#xD;
        control trial or have enrolled patients of primary biliary cirrhosis only.&#xD;
  &#xD;
        So, there is a need to have double blind RCT assessing efficacy and safety of oral&#xD;
        bisphosphonates in non-cholestatic liver cirrhosis.&#xD;
  &#xD;
        In this study, we hypothesize that oral ibandronate significantly improves BMD in patients of&#xD;
        liver cirrhosis &amp; is safe in patients with low risk esophageal varices. With this study, we&#xD;
        aim to assess the efficacy and safety of oral ibandronate in patients of liver cirrhosis with&#xD;
        hepatic osteodystrophy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hypothesis : Oral ibandronate 150 mg once monthly significantly improves BMD in patients of&#xD;
        liver cirrhosis with hepatic osteodystrophy by decreasing bone resorption &amp; is safe in&#xD;
        patients with low risk esophageal varices.&#xD;
  &#xD;
        Methodology:&#xD;
  &#xD;
        Study population: All the consecutive patients with liver cirrhosis attending department of&#xD;
        Hepatology will be evaluated for inclusion criteria. The diagnosis of cirrhosis will be&#xD;
        confirmed either by liver biopsy or associated clinical, radiological and endoscopic findings&#xD;
        compatible with cirrhosis and PH.&#xD;
  &#xD;
        All enrolled patients will undergo detailed evaluation by thorough history ,clinical&#xD;
        examination and relevant laboratory investigations.&#xD;
  &#xD;
        All cirrhotic patients will be subjected to upper GI endoscopy. Patients with low risk&#xD;
        esophageal varices(grade I and II without red-color signs) and low risk GOV-1/GOV2 will be&#xD;
        subjected to DEXA scan to measure BMD at femur neck and lumbar spine. Patient with grade II&#xD;
        and III varices with RCS will be enrolled only after EVL after 6-8 weeks until varices&#xD;
        achieve a low risk status described as eradicated/grade I &amp; II varices without RCS&#xD;
  &#xD;
        Patients with HOD (osteoporosis according to WHO criteria :BMD T score&lt; -2.5) or with&#xD;
        osteopenia(BMD T score between -1 and -2.5) will be enrolled in our study&#xD;
  &#xD;
        Informed consent will be taken from all patients.&#xD;
  &#xD;
        Study design: Prospective double blind randomized control trial&#xD;
  &#xD;
        Study period: 1 year Sample size: 80&#xD;
  &#xD;
        Our primary objective is to compare changes in BMD (delta T) at lumbar spine in DEXA scan&#xD;
        after 1 year of oral ibandronate therapy. As shown by Guanabens N et al. Hepatology 2013&#xD;
        Dec;58(6):2070-8) that assuming baseline T score in both groups(Ibandronate &amp; placebo) were&#xD;
        comparable &amp; after 1 year the mean T score increased by 0.393 i.e delta T of 0.393 in&#xD;
        bisphosphonate group &amp; delta T of 0.1 in placebo group, we need to enroll 68 cases i.e 34 in&#xD;
        each group with alpha error of 5% &amp; power 95%. Further assuming defaulter rate of 20%, it is&#xD;
        decided to enroll 80 cases i.e 40 in each group randomly allocated into 2 groups by block&#xD;
        randomization method taking block size of 8.&#xD;
  &#xD;
        Intervention: All enrolled patients will be randomly allocated into 2 groups by block&#xD;
        randomization method taking block size of 8.&#xD;
  &#xD;
        Group A will receive Ibandronate 150 mg once monthly in a supervised manner in front of&#xD;
        student investigator and will be observed for 2 hours following ingestion. Group A will also&#xD;
        receive Calcium and Vitamin D3. Group B will receive placebo once monthly along with Calcium&#xD;
        and Vitamin D3&#xD;
  &#xD;
        Monitoring and assessment:&#xD;
  &#xD;
        Group A will receive Ibandronate 150 mg once monthly in fasting state with a glass of water&#xD;
        in sitting posture and the patient will be instructed to not to lie down or eat for at least&#xD;
        30 minutes. Contact number of student investigator will be given to the patient to report&#xD;
        symptoms in the next 48 hours. .Patient will be asked to maintain diary to report and monitor&#xD;
        symptoms and inform student investigator&#xD;
  &#xD;
        CBC ,KFT, LFT, PT/INR, HBsAg, HCV, ANA, ASMA, Anti-LKM, Ceruloplasmin and iron studies will&#xD;
        be carried out in all enrolled patients at the time of enrollment. USG abdomen will be&#xD;
        performed in all cases and triple phase CT of abdomen when there will be suspicion of HCC.&#xD;
        Serum calcium, phosphate,25(OH)D, Fasting thyroid profile and PTH level will also be&#xD;
        estimated.&#xD;
  &#xD;
        Following four biochemical markers of bone turnover will be tested at entry and end of study:&#xD;
  &#xD;
          -  Serum osteocalcin,&#xD;
  &#xD;
          -  PICP( procollagen type 1 C propeptide)&#xD;
  &#xD;
          -  NTX (aminoterminal cross-linking telopeptide of type I collagen)&#xD;
  &#xD;
          -  CTX (carboxyterminal cross-linking telopeptide of type I collagen)&#xD;
  &#xD;
        Lateral radiograph of thoracic and lumbar spine will be obtained at entry and after 1 year in&#xD;
        all patients to disclose fracture rates in both groups. Vertebral fracture will be defined as&#xD;
        reduction of &gt;20 % in the anterior, middle or posterior height of vertebral body. Fracture&#xD;
        attributable to major trauma will not be recorded. Development of new peripheral fracture due&#xD;
        to trivial trauma will also be monitored All patients will be followed every month and oral&#xD;
        ibandronate will be given in a supervised manner under observation of student investigator&#xD;
        for 2 hours.&#xD;
  &#xD;
        Biochemical bone turnover marker and DEXA scan will be repeated after 1 year of follow up.&#xD;
        LFT and Liver fraility index will be assessed every 3 month. Upper GI endoscopy will be&#xD;
        repeated at the end of study and as when required.&#xD;
  &#xD;
        Adverse effects: Patients may be made aware of the possible side effects of the study drug.&#xD;
        During each follow up visit, patient will be thoroughly evaluated for any side effects of&#xD;
        ibandronate: UGI bleed, dyspeptic symptoms, and musculoskeletal symptoms&#xD;
        (myalgia/arthralgia).Only complaints within 48 hours of taking medicine that limit daily&#xD;
        activities will be documented.&#xD;
  &#xD;
        Stopping rule: Patient experiencing UGI bleed, dyspeptic symptoms, and musculoskeletal&#xD;
        symptoms (myalgia/arthralgia) within 48 hours of oral ibandronate, intractable dyspeptic&#xD;
        symptoms.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</primary_completion_date>
    <phase>N/A</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, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in BMD at lumbar spine</measure>
      <time_frame>1 year</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in BMD at femur neck</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of UGI bleed in both arms</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in bone turnover marker after 1 year of ibandronate</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Association between T-score of DEXA scan at lumbar spine and femur neck with (Child-Turcotte-Pugh (CTP) score.</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Association between T-score of DEXA scan at lumbar spine and femur neck with Model for End Stage Liver Disease score.</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fracture rate after 1 year of ibandronate therapy</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in liver fraility index after 1 year of ibandronate therapy</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Hepatic Osteodystrophy</condition>
    <condition>Liver Cirrhosis</condition>
    <arm_group>
      <arm_group_label>Ibandronate</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Ibandronate 150 mg once monthly in a supervised manner in front of student investigator and will be observed for 2 hours following ingestion. Patients will also receive Calcium 500mg BD and Vitamin D3 1000 mg OD</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group B will receive placebo once monthly along with Calcium 500mg BD and Vitamin D3 1000 mg OD</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ibandronate</intervention_name>
      <description>Ibandronate 150 mg once monthly.</description>
      <arm_group_label>Ibandronate</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Calcium</intervention_name>
      <description>Calcium 500 mg twice daily</description>
      <arm_group_label>Ibandronate</arm_group_label>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Vitamin D3</intervention_name>
      <description>Vitamin D3 - 1000 IU daily</description>
      <arm_group_label>Ibandronate</arm_group_label>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Liver cirrhosis patients between 18 to 70 yrs with low risk esophageal varices and HOD&#xD;
               (osteoporosis/osteopenia will be enrolled).&#xD;
  &#xD;
            2. Patient and attendants willing to give informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Age &lt;18 years and &gt; 70 years&#xD;
  &#xD;
            2. Patients with prior history of fracture&#xD;
  &#xD;
            3. History of upper GI bleed in last 2 months&#xD;
  &#xD;
            4. Patients with post EVL ulcers&#xD;
  &#xD;
            5. High risk esophageal varices or gastric varices without endoscopic treatment.&#xD;
  &#xD;
            6. Active peptic ulcer&#xD;
  &#xD;
            7. Severe vascular ectasia&#xD;
  &#xD;
            8. Esophageal stricture&#xD;
  &#xD;
            9. Achalasia&#xD;
  &#xD;
           10. Creatinine clearance below 30ml/min&#xD;
  &#xD;
           11. Malignancy(except HCC)&#xD;
  &#xD;
           12. Hyperparathyroidism&#xD;
  &#xD;
           13. Patients using NSAIDs, corticosteroids ,anticoagulants or ongoing alcohol beverages&#xD;
  &#xD;
           14. Bisphosphonate hypersensitivity/Oral bisphosphonate within 12 months&#xD;
  &#xD;
           15. Grade 2/3 ascites&#xD;
  &#xD;
           16. Hepatic encephalopathy(Grade 3 &amp;4)&#xD;
  &#xD;
           17. Critically ill patients&#xD;
  &#xD;
           18. Post LT patients&#xD;
  &#xD;
           19. HRT within 6 mths&#xD;
  &#xD;
           20. Pregnant and lactating women&#xD;
  &#xD;
           21. Patient with bleeding disorders&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dr Sudhir Kumar Verma, MD</last_name>
      <phone>01146300000</phone>
      <email>sudhirkgmu@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Institute of Liver &amp; Biliary Sciences (ILBS)</name>
        <address>
          <city>New Delhi</city>
          <state>Delhi</state>
          <zip>110070</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr Sudhir Kumar Verma, MD</last_name>
        <phone>01146300000</phone>
        <email>sudhirkgmu@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</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>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>Vitamin D</mesh_term>
      <mesh_term>Cholecalciferol</mesh_term>
      <mesh_term>Ibandronic Acid</mesh_term>
      <mesh_term>Calcium</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06022237
  org study id: ILBS-Cirrhosis-61
  nct id: NCT06022237
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Hepatic osteodystrophy(HOD) is a common but frequently overlooked complication of liver
        cirrhosis with a prevalence rate ranging from 13-70%. Bisphosphonates acting by inhibiting
        bone resorption are frequently used. Intravenous infusions of bisphosphonates may cause
        prolonged arthralgia and myalgia whereas oral bisphosphonates may cause digestive mucosal
        damage causing dysphagia, esophagitis and ulcer. Such side effects have discouraged the
        prescription of oral bisphosphonates for patients of cirrhosis mainly due to risk of upper GI
        hemorrhage arising from esophageal variceal rupture.
  
        All studies done in past with bisphosphonates are either open labelled RCT/ non- randomized
        control trial or have enrolled patients of primary biliary cirrhosis only.
  
        So, there is a need to have double blind RCT assessing efficacy and safety of oral
        bisphosphonates in non-cholestatic liver cirrhosis.
  
        In this study, we hypothesize that oral ibandronate significantly improves BMD in patients of
        liver cirrhosis & is safe in patients with low risk esophageal varices. With this study, we
        aim to assess the efficacy and safety of oral ibandronate in patients of liver cirrhosis with
        hepatic osteodystrophy
  Hypothesis : Oral ibandronate 150 mg once monthly significantly improves BMD in patients of
        liver cirrhosis with hepatic osteodystrophy by decreasing bone resorption & is safe in
        patients with low risk esophageal varices.
  
        Methodology:
  
        Study population: All the consecutive patients with liver cirrhosis attending department of
        Hepatology will be evaluated for inclusion criteria. The diagnosis of cirrhosis will be
        confirmed either by liver biopsy or associated clinical, radiological and endoscopic findings
        compatible with cirrhosis and PH.
  
        All enrolled patients will undergo detailed evaluation by thorough history ,clinical
        examination and relevant laboratory investigations.
  
        All cirrhotic patients will be subjected to upper GI endoscopy. Patients with low risk
        esophageal varices(grade I and II without red-color signs) and low risk GOV-1/GOV2 will be
        subjected to DEXA scan to measure BMD at femur neck and lumbar spine. Patient with grade II
        and III varices with RCS will be enrolled only after EVL after 6-8 weeks until varices
        achieve a low risk status described as eradicated/grade I & II varices without RCS
  
        Patients with HOD (osteoporosis according to WHO criteria :BMD T score< -2.5) or with
        osteopenia(BMD T score between -1 and -2.5) will be enrolled in our study
  
        Informed consent will be taken from all patients.
  
        Study design: Prospective double blind randomized control trial
  
        Study period: 1 year Sample size: 80
  
        Our primary objective is to compare changes in BMD (delta T) at lumbar spine in DEXA scan
        after 1 year of oral ibandronate therapy. As shown by Guanabens N et al. Hepatology 2013
        Dec;58(6):2070-8) that assuming baseline T score in both groups(Ibandronate & placebo) were
        comparable & after 1 year the mean T score increased by 0.393 i.e delta T of 0.393 in
        bisphosphonate group & delta T of 0.1 in placebo group, we need to enroll 68 cases i.e 34 in
        each group with alpha error of 5% & power 95%. Further assuming defaulter rate of 20%, it is
        decided to enroll 80 cases i.e 40 in each group randomly allocated into 2 groups by block
        randomization method taking block size of 8.
  
        Intervention: All enrolled patients will be randomly allocated into 2 groups by block
        randomization method taking block size of 8.
  
        Group A will receive Ibandronate 150 mg once monthly in a supervised manner in front of
        student investigator and will be observed for 2 hours following ingestion. Group A will also
        receive Calcium and Vitamin D3. Group B will receive placebo once monthly along with Calcium
        and Vitamin D3
  
        Monitoring and assessment:
  
        Group A will receive Ibandronate 150 mg once monthly in fasting state with a glass of water
        in sitting posture and the patient will be instructed to not to lie down or eat for at least
        30 minutes. Contact number of student investigator will be given to the patient to report
        symptoms in the next 48 hours. .Patient will be asked to maintain diary to report and monitor
        symptoms and inform student investigator
  
        CBC ,KFT, LFT, PT/INR, HBsAg, HCV, ANA, ASMA, Anti-LKM, Ceruloplasmin and iron studies will
        be carried out in all enrolled patients at the time of enrollment. USG abdomen will be
        performed in all cases and triple phase CT of abdomen when there will be suspicion of HCC.
        Serum calcium, phosphate,25(OH)D, Fasting thyroid profile and PTH level will also be
        estimated.
  
        Following four biochemical markers of bone turnover will be tested at entry and end of study:
  
          -  Serum osteocalcin,
  
          -  PICP( procollagen type 1 C propeptide)
  
          -  NTX (aminoterminal cross-linking telopeptide of type I collagen)
  
          -  CTX (carboxyterminal cross-linking telopeptide of type I collagen)
  
        Lateral radiograph of thoracic and lumbar spine will be obtained at entry and after 1 year in
        all patients to disclose fracture rates in both groups. Vertebral fracture will be defined as
        reduction of >20 % in the anterior, middle or posterior height of vertebral body. Fracture
        attributable to major trauma will not be recorded. Development of new peripheral fracture due
        to trivial trauma will also be monitored All patients will be followed every month and oral
        ibandronate will be given in a supervised manner under observation of student investigator
        for 2 hours.
  
        Biochemical bone turnover marker and DEXA scan will be repeated after 1 year of follow up.
        LFT and Liver fraility index will be assessed every 3 month. Upper GI endoscopy will be
        repeated at the end of study and as when required.
  
        Adverse effects: Patients may be made aware of the possible side effects of the study drug.
        During each follow up visit, patient will be thoroughly evaluated for any side effects of
        ibandronate: UGI bleed, dyspeptic symptoms, and musculoskeletal symptoms
        (myalgia/arthralgia).Only complaints within 48 hours of taking medicine that limit daily
        activities will be documented.
  
        Stopping rule: Patient experiencing UGI bleed, dyspeptic symptoms, and musculoskeletal
        symptoms (myalgia/arthralgia) within 48 hours of oral ibandronate, intractable dyspeptic
        symptoms.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Change in BMD at lumbar spine
  time frame: 1 year
  measure: Change in BMD at femur neck
  time frame: 1 year
  measure: Incidence of UGI bleed in both arms
  time frame: 1 year
  measure: Change in bone turnover marker after 1 year of ibandronate
  time frame: 1 year
  measure: Association between T-score of DEXA scan at lumbar spine and femur neck with (Child-Turcotte-Pugh (CTP) score.
  time frame: 1 year
  measure: Association between T-score of DEXA scan at lumbar spine and femur neck with Model for End Stage Liver Disease score.
  time frame: 1 year
  measure: Fracture rate after 1 year of ibandronate therapy
  time frame: 1 year
  measure: Change in liver fraility index after 1 year of ibandronate therapy
  time frame: 1 year
  arm group label: Ibandronate
  arm group type: Experimental
  description: Ibandronate 150 mg once monthly in a supervised manner in front of student investigator and will be observed for 2 hours following ingestion. Patients will also receive Calcium 500mg BD and Vitamin D3 1000 mg OD
  arm group label: Placebo
  arm group type: Active Comparator
  description: Group B will receive placebo once monthly along with Calcium 500mg BD and Vitamin D3 1000 mg OD
  intervention type: Drug
  intervention name: Ibandronate
  description: Ibandronate 150 mg once monthly.
  arm group label: Ibandronate
  intervention type: Drug
  intervention name: Calcium
  description: Calcium 500 mg twice daily
  arm group label: Ibandronate
  arm group label: Placebo
  intervention type: Drug
  intervention name: Vitamin D3
  description: Vitamin D3 - 1000 IU daily
  arm group label: Ibandronate
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Dr Sudhir Kumar Verma, MD
  phone: 01146300000
  email: sudhirkgmu@gmail.com
  facility: 
  contact: 
  country: India
  responsible party type: Sponsor
  mesh term: Liver Cirrhosis
  mesh term: Fibrosis
  mesh term: Vitamin D
  mesh term: Cholecalciferol
  mesh term: Ibandronic Acid
  mesh term: Calcium
  sharing ipd: No