NCT03399227

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2020

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
2.4 years until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

2.8 years

First QC Date

January 5, 2018

Last Update Submit

September 9, 2020

Conditions

Liver DiseasesTransplant-Related DisorderOsteoporosis

Keywords

Bone microarchitecture

Outcome Measures

Primary Outcomes (1)

  • Bone microarchitecture of the distal radius

    trabecular bone mineral density measurement (XCT)

    12 months to posttransplantation

Secondary Outcomes (5)

  • Bone microarchitecture of the distal radius

    pretransplantation to 12 after transplantation

  • Bone microarchitecture of the distal radius

    pretransplantation to 12 after transplantation

  • Bone microarchitecture of the distal radius

    pretransplantation to 12 after transplantation

  • Bone microarchitecture of the distal radius

    pretransplantation to 12 after transplantation

  • Bone microarchitecture of the distal radius

    pretransplantation to 12 months after transplantation

Other Outcomes (10)

  • Bone mineral density

    pretransplantation to 12 after transplantation

  • Bone mineral density

    pretransplantation to 12 after transplantation

  • Biochemical

    pretransplantation to 12 after transplantation

  • +7 more other outcomes

Study Arms (2)

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)

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50 patients awaiting liver transplantation and 50 age and gender matched healthy controls

You may qualify if:

  • Women, men awaiting liver Transplantation
  • years of age

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood samples

MeSH Terms

Conditions

Liver DiseasesOsteoporosis

Condition Hierarchy (Ancestors)

Digestive System DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Katharina Kerschan-Schindl, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assoc professor

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 16, 2018

Study Start

June 1, 2020

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

September 11, 2020

Record last verified: 2020-09