Status:
WITHDRAWN
Liver Transplantation: Skeletal Effects
Lead Sponsor:
Medical University of Vienna
Conditions:
Liver Diseases
Transplant-Related Disorder
Eligibility:
All Genders
20-70 years
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 trans...
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 ...
Eligibility Criteria
Inclusion
- Women, men awaiting liver Transplantation
- 20-70 years of age
Exclusion
- 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)
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03399227
Start Date
June 1 2020
End Date
March 31 2023
Last Update
September 11 2020
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