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Liver Transplantation: Skeletal Effects

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ClinicalTrials.gov Identifier: NCT03399227
Recruitment Status : Withdrawn (no funding)
First Posted : January 16, 2018
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Katharina Kerschan-Schindl, Medical University of Vienna

Brief Summary:
Fifty patients awaiting liver transplantation and 50 age and gender matched control subjects with normal liver function will be included in the study. The aim of this project is to compare liver transplantation recipients'bone microarchitecture with healthy controls and to evaluate patients' changes within one year after transplantation

Condition or disease
Liver Diseases Transplant-Related Disorder Osteoporosis

Detailed Description:

Background: Solid organ transplantation recipients have a high prevalence of osteoporosis and fragility fractures. Deteriorated bone architecture has been shown by high resolution computed tomography (HR-pQCT) in kidney and lung transplantation recipients. In liver transplantation (LeTx) recipients, bone microarchitecture has only been evaluated using the trabecular bone score in a retrospective cohort study; a degraded or partially degraded microarchitecture was detected in most of the patients.

Aim: The aim of this project is to compare LeTx recipients' bone microarchitecture with healthy controls and to evaluate patients' changes within one year after transplantation.

Methods: HR-pQCT scans of the distal radius and tibia as well as areal bone mineral density measurement of the lumbar spine and hip region will be performed before Tx, 1 and 12 months after Tx in 50 patients. Anabolic and catabolic markers of bone turnover (sclerostin, dickkopf 1, periostin) and traditional bone turnover markers will be evaluated preoperatively, on the day of surgery, and 4 times within the first year after LeTx. In healthy age- and sex-matched controls HR-pQCT, bone mineral density and laboratory parameters will be assessed once.

Hypotheses: Based on the HR-pQCT data of kidney and lung transplantation recipients and the trabecular bone score of LeTx recipients, the investigators hypothesize that LeTX recipients have deteriorated bone microarchitecture.

Expected outcome: Since bone fragility is not only determined by BMD but bone architecture as well, HR-pQCT data give important information on the patients' bone fragility. The knowledge of the course of bone microarchitecture after liver transplantation may help to develop strategies preventing fragility fractures in LeTx recipients.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Skeletal Effects of Liver Transplantation
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Liver transplantation recipients
Venipuncture (6x) Bone mineral density measurement: lumbar spine, hip region (3x) high resolution peripheral quantitative CT: radius, tibia (3x)
Control group
Venipuncture (1x) Bone mineral density measurement: lumbar spine, hip region (1x) high resolution peripheral quantitative CT: radius, tibia (1x)



Primary Outcome Measures :
  1. Bone microarchitecture of the distal radius [ Time Frame: 12 months to posttransplantation ]
    trabecular bone mineral density measurement (XCT)


Secondary Outcome Measures :
  1. Bone microarchitecture of the distal radius [ Time Frame: pretransplantation to 12 after transplantation ]
    bone volume fraction (%)

  2. Bone microarchitecture of the distal radius [ Time Frame: pretransplantation to 12 after transplantation ]
    trabecular homogeneity (mm)

  3. Bone microarchitecture of the distal radius [ Time Frame: pretransplantation to 12 after transplantation ]
    trabecular number (mm-1)

  4. Bone microarchitecture of the distal radius [ Time Frame: pretransplantation to 12 after transplantation ]
    trabecular thickness (mm)

  5. Bone microarchitecture of the distal radius [ Time Frame: pretransplantation to 12 months after transplantation ]
    trabecular separation (mm)


Other Outcome Measures:
  1. Bone mineral density [ Time Frame: pretransplantation to 12 after transplantation ]
    areal bone density measurement of the lumbar spine (T score)

  2. Bone mineral density [ Time Frame: pretransplantation to 12 after transplantation ]
    areal bone density measurement of the hip region (T score)

  3. Biochemical [ Time Frame: pretransplantation to 12 after transplantation ]
    Serum levels of osteocalcin

  4. Biochemical [ Time Frame: pretransplantation to 12 after transplantation ]
    Serum levels of bone-specific alkaline phosphatase

  5. Biochemical [ Time Frame: pretransplantation to 12 after transplantation ]
    Serum levels of procollagen type 1 amino-terminal propeptide

  6. Biochemical [ Time Frame: pretransplantation to 12 after transplantation ]
    Serum levels of tartrate resistant acid phosphatase

  7. Biochemical [ Time Frame: pretransplantation to 12 after transplantation ]
    Serum levels of carboxy-terminal collagen crosslinks

  8. Biochemical [ Time Frame: pretransplantation to 12 after transplantation ]
    Serum levels of dickkopf 1

  9. Biochemical [ Time Frame: pretransplantation to 12 after transplantation ]
    Serum levels of periostin

  10. Biochemical [ Time Frame: pretransplantation to 12 after transplantation ]
    Serum levels of sclerostin


Biospecimen Retention:   Samples Without DNA
venous blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
50 patients awaiting liver transplantation and 50 age and gender matched healthy controls
Criteria

Inclusion Criteria:

  • Women, men awaiting liver Transplantation
  • 20-70 years of age

Exclusion Criteria:

  • Subjects with a history of prior solid organ transplantation
  • Subjects awaiting a combined liver-kidney transplantation
  • Cancer within the previous 5 years - except for hepatocellular carcinoma, neuroendocrine tumors and hemangioendothelioma with indication for liver transplantation
  • Rheumatoid arthritis
  • Severe renal insufficiency (chronic kidney disease IV, V)
  • Immobilisation
  • Intake of drugs with potential effects on BMD like lithium, estrogen-replacement therapy, selective Estrogen-receptor modulators, oral bisphosphonates in the last three months, denosumab and parenteral bisphosphonates in the last year - except calcium, vitamin D and medication necessary for the underlying disease
  • Non-osteoporotic bone disease
  • Recent fragility fracture within 6 months

Control group:

Inclusion Criteria:

  • Women, men
  • 20-70 years of age
  • Normal liver function (defined as liver function parameters and transaminases, such as albumin, thromboplastin time, alanine-aminotransferase, aspartate-aminotransferase, and gamma-glutamyl-transferase within the normal range)

Additional exclusion Criteria:

  • Osteoporosis according to BMD measurement or osteopenia plus fragility fracture
  • Liver disease (defined as evidence of significant liver disease according to laboratory testing)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399227


Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Katharina Kerschan-Schindl, MD Medical University of Vienna
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Responsible Party: Katharina Kerschan-Schindl, MD, Assoc professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03399227    
Other Study ID Numbers: 1713/2017
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katharina Kerschan-Schindl, Medical University of Vienna:
Bone microarchitecture
Additional relevant MeSH terms:
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Osteoporosis
Liver Diseases
Digestive System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases