Liver DiseasesNCT03399227
Liver Transplantation: Skeletal Effects
An observational study of Liver Diseases and Transplant-Related Disorder, run by Medical University of Vienna.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases, Transplant-Related Disorder, Osteoporosis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 patients awaiting liver transplantation and 50 age and gender matched healthy controls
Who may be able to join
- Women, men awaiting liver Transplantation
- 20-70 years of age
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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:
About this study
Official title: Skeletal Effects of Liver Transplantation
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
Read the 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.
- Conditions
- Liver Diseases, Transplant-Related Disorder, Osteoporosis
- Keywords
- Bone microarchitecture
- Medical subject headings
- Liver Diseases, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone microarchitecture of the distal radius
trabecular bone mineral density measurement (XCT)
Measured: 12 months to posttransplantation
Secondary outcomes (5)
Bone microarchitecture of the distal radius
bone volume fraction (%)
Measured: pretransplantation to 12 after transplantation
Bone microarchitecture of the distal radius
trabecular homogeneity (mm)
Measured: pretransplantation to 12 after transplantation
Bone microarchitecture of the distal radius
trabecular number (mm-1)
Measured: pretransplantation to 12 after transplantation
Bone microarchitecture of the distal radius
trabecular thickness (mm)
Measured: pretransplantation to 12 after transplantation
Bone microarchitecture of the distal radius
trabecular separation (mm)
Measured: pretransplantation to 12 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start1 Jun 2020 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katharina Kerschan-Schindl, Medical University of Vienna
- Investigators
- Katharina Kerschan-Schindl, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399227
- Sponsor's protocol ID
- 1713/2017
- Status last verified
- Sep 2020
- First submitted
- 5 Jan 2018
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Effects of Liver Transplantation
- ClinicalTrials.gov ID
- NCT03399227
- Acronym / sponsor ID
- 1713/2017
- Conditions
- Liver Diseases, Transplant-Related Disorder, Osteoporosis
- Keywords
- Bone microarchitecture
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients awaiting liver transplantation and 50 age and gender matched healthy controls
Key inclusion criteria (8 listed)
- Women, men awaiting liver Transplantation
- 20-70 years of age
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone microarchitecture of the distal radius
Time frame: 12 months to posttransplantation
trabecular bone mineral density measurement (XCT)
5 secondary outcomes
Bone microarchitecture of the distal radius
Time frame: pretransplantation to 12 after transplantation
Bone microarchitecture of the distal radius
Time frame: pretransplantation to 12 after transplantation
Bone microarchitecture of the distal radius
Time frame: pretransplantation to 12 after transplantation
Bone microarchitecture of the distal radius
Time frame: pretransplantation to 12 after transplantation
Bone microarchitecture of the distal radius
Time frame: pretransplantation to 12 months after transplantation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharina Kerschan-Schindl, MD principal investigator
Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Transplant-Related Disorder, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone microarchitecture of the distal radius (time frame: 12 months to posttransplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020; AzTrials last refreshed its copy on 29 Oct 2026.