Metabolic Bone DiseaseVFANCT03811873
Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates
A study testing Dual x-ray absorptiometry and Vertebral Fracture Assessment in people with Metabolic Bone Disease and Transplant-Related Disorder, run by Mayo Clinic at 1 site in United States.
Trial summary
The researchers are trying to compare the effectiveness of Vertebral Fracture Assessment (VFA) in addition to the current standard of care spine x-ray in evaluation pre-liver transplant patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Bone Disease, Transplant-Related Disorder, Secondary Osteoporosis
- What is being tested?
- Dual x-ray absorptiometry and Vertebral Fracture Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2019to 30 Aug 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First time liver transplant candidates deemed too early for liver transplant
- 24 hour urine Creatinine clearance of > 40 mg/dl. However bone turnover markers (beta CTx and P1NP) will be measured only in those with creatinine clearance >60mg/dl
Who cannot join
- Patients with prior solid organ transplantation
- Liver/kidney combination will be excluded
- Patients with 24 hr. urine creatinine clearance < 40mL/minute
- Patients who have been on osteoporosis medications - Bisphosphonates [Fosamax (Alendronate), Actonel (Risedronate), Boniva (Ibandronate), or Reclast (Zoledronic acid)] Teriparatide (Forteo), Abaloparatide (Tymlos), Denosumab (Prolia), within the past 5 years
- Use of other systemic medications that can effect bone remodeling including sex hormone replacement therapy (estrogen or testosterone), calcitonin, androgen deprivation therapy, aromatase inhibitors, or SERMS in the past 6 months
- Underlying disease that significantly impacts bone metabolism such as primary hyperparathyroidism, hyperthyroidism, Paget's disease of bone, fibrous dysplasia, or malignancies with skeletal metastases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Vertebral Fracture Risk Using VFA and Vertebral Strength Assessment With DXA-Finite Element Analysis in Liver Transplant Recipients in Pretransplant Period
The researchers are trying to compare the effectiveness of Vertebral Fracture Assessment (VFA) in addition to the current standard of care spine x-ray in evaluation pre-liver transplant patients.
- Being tested
- Dual x-ray absorptiometry, Vertebral Fracture Assessment
- Keywords
- transplant related disorders, liver transplant, transplant related bone disease
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual x-ray absorptiometryDiagnostic test
Also called DEXA, Bone mineral density
DEXA is a means of measuring bone mineral density (BMD) using spectral imaging. Two X-ray beams, with different energy levels, are aimed at the bones. Soft tissue absorption is subtracted out, then the bone mineral density (BMD) can be determined from the absorption of each beam by bone.
Vertebral Fracture AssessmentOther
Lumbar/thoracic spine x-ray and labs assessed for bone turnover markers.
| Study group | Role | What they receive |
|---|---|---|
| Vertebral fracture assessment | Other | Study participants undergoing evaluation for liver transplant and deemed to early for transplant will receive standard of care bone mineral density and vertebral fracture assessment.. Receives: Diagnostic Test: Dual x-ray absorptiometry; Other: Vertebral Fracture Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident of clinical fractures validated by spine x-ray or other imaging (vertebral fracture assessment -VFA)
Proportion of participants experiencing a clinical fracture validated by x-ray or other imaging (VFA) as compared to standard of care ( Spine X-ray)
Measured: 24 months
Secondary outcomes (3)
Changes in bone mineral density by dual x-ray absorptiometry
Bone mineral density changes seen in end stage liver disease in (grams/cm2) at baseline and 12 months
Measured: 24 months
Percent changes from baseline to 12 months estimation of bone strength derived from finite element analysis
Bone strength measurements derived from finite element assessment changes from baseline to 12 months and correlation with clinical and radiographic risk of fracture
Measured: 24 months
Changes in bone turnover markers in end stage liver disease
Bone turnover markers (Beta CTX, P1NP) percent changes from baseline to 12 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start18 Feb 2019
- Primary completion27 Jul 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Bone DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Testing a single group of participants who are first time liver transplant candidates.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ejigayehu G. Abate, Mayo Clinic
- Investigators
- Ejigayehu G Abate, M.D, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811873
- Sponsor's protocol ID
- 18-004899
- Acronym
- VFA
- Status last verified
- May 2023
- First submitted
- 4 Jan 2019
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vertebral Fracture Risk Using VFA and Vertebral Strength Assessment With DXA-Finite Element Analysis in Liver Transplant Recipients in Pretransplant Period
- ClinicalTrials.gov ID
- NCT03811873
- Acronym / sponsor ID
- VFA / 18-004899
- Keywords
- transplant related disorders, liver transplant, transplant related bone disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 22 Jan 2019 (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.
The researchers are trying to compare the effectiveness of Vertebral Fracture Assessment (VFA) in addition to the current standard of care spine x-ray in evaluation pre-liver transplant patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Testing a single group of participants who are first time liver transplant candidates.
| Arm | Type | Receives |
|---|---|---|
| Vertebral fracture assessment | Other | Diagnostic Test: Dual x-ray absorptiometry, Other: Vertebral Fracture AssessmentStudy participants undergoing evaluation for liver transplant and deemed to early for transplant will receive standard of care bone mineral density and vertebral fracture assessment.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- First time liver transplant candidates deemed too early for liver transplant
- 24 hour urine Creatinine clearance of > 40 mg/dl. However bone turnover markers (beta CTx and P1NP) will be measured only in those with creatinine clearance >60mg/dl
Key exclusion criteria (6 listed)
- Patients with prior solid organ transplantation
- Liver/kidney combination will be excluded
- Patients with 24 hr. urine creatinine clearance < 40mL/minute
- Patients who have been on osteoporosis medications - Bisphosphonates [Fosamax (Alendronate), Actonel (Risedronate), Boniva (Ibandronate), or Reclast (Zoledronic acid)] Teriparatide (Forteo), Abaloparatide (Tymlos), Denosumab (Prolia), within the past 5 years
- Use of other systemic medications that can effect bone remodeling including sex hormone replacement therapy (estrogen or testosterone), calcitonin, androgen deprivation therapy, aromatase inhibitors, or SERMS in the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual x-ray absorptiometryAlso: DEXA, Bone mineral densityDEXA is a means of measuring bone mineral density (BMD) using spectral imaging. Two X-ray beams, with different energy levels, are aimed at the bones. Soft tissue absorption is subtracted out, then the bone mineral density (BMD) can be determined from the absorption of each beam by bone. | Diagnostic test | Vertebral fracture assessment |
| Vertebral Fracture AssessmentLumbar/thoracic spine x-ray and labs assessed for bone turnover markers. | Other | Vertebral fracture assessment |
Primary outcome
Incident of clinical fractures validated by spine x-ray or other imaging (vertebral fracture assessment -VFA)
Time frame: 24 months
Proportion of participants experiencing a clinical fracture validated by x-ray or other imaging (VFA) as compared to standard of care ( Spine X-ray)
3 secondary outcomes
Changes in bone mineral density by dual x-ray absorptiometry
Time frame: 24 months
Percent changes from baseline to 12 months estimation of bone strength derived from finite element analysis
Time frame: 24 months
Changes in bone turnover markers in end stage liver disease
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Ejigayehu G Abate, M.D principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual x-ray absorptiometry and Vertebral Fracture Assessment in people with Metabolic Bone Disease and Transplant-Related Disorder, run by Mayo Clinic at 1 site in United States.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incident of clinical fractures validated by spine x-ray or other imaging (vertebral fracture assessment -VFA) (time frame: 24 months). 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 6 May 2023.