Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates

Transplant-Related Disorder Clinical Trial

— VFA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03811873
• Other study ID #: 18-004899
• Status: Completed
• Phase: N/A
• Start date: February 18, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: May 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 30, 2022
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• 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

Exclusion criteria

• 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

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Metabolic Bone Disease
• Osteoporosis
• Secondary Osteoporosis
• Spinal Fractures
• Transplant-Related Disorder

Intervention

Diagnostic Test:
• Dual x-ray absorptiometry
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.

Other:
• Vertebral Fracture Assessment
Lumbar/thoracic spine x-ray and labs assessed for bone turnover markers.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	24 months
Secondary	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	24 months
Secondary	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	24 months
Secondary	Changes in bone turnover markers in end stage liver disease	Bone turnover markers (Beta CTX, P1NP) percent changes from baseline to 12 months	24 months

External Links

•   Mayo Clinic Clinical Trials