Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates

Not Applicable

Completed

• Conditions: Metabolic Bone Disease; Secondary Osteoporosis; Transplant-Related Disorder
• Interventions: Diagnostic Test: Dual x-ray absorptiometry; Other: Vertebral Fracture Assessment

• Registration Number: NCT03811873
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-04
• Study First Submitted QC: 2019-01-18
• Study First Posted: 2019-01-22
• Study Start: 2019-02-18
• Primary Completion: 2022-07-27
• Study Completion: 2022-08-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vertebral fracture assessment	Vertebral Fracture Assessment	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..
Vertebral fracture assessment	Dual x-ray absorptiometry	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..

Primary Outcome Measures

Name	Time	Method
Incident of clinical fractures validated by spine x-ray or other imaging (vertebral fracture assessment -VFA)	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)

Secondary Outcome Measures

Name	Time	Method
Changes in bone mineral density by dual x-ray absorptiometry	24 months	Bone mineral density changes seen in end stage liver disease in (grams/cm2) at baseline and 12 months
Changes in bone turnover markers in end stage liver disease	24 months	Bone turnover markers (Beta CTX, P1NP) percent changes from baseline to 12 months
Percent changes from baseline to 12 months estimation of bone strength derived from finite element analysis	24 months	Bone strength measurements derived from finite element assessment changes from baseline to 12 months and correlation with clinical and radiographic risk of fracture

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States