Organ transplant recipients are known to suffer from bone loss and subsequent fractures after the transplant operation with the most rapid bone loss occurring within the first 3-12 months. Guidelines for prevention and treatment of this serious complication are only written by individual medical societies interested in each organ (separate kidney from liver or heart transplants management) and they are based on studies done with limited medications choices. The majority of studies are done with the use of bisphosphonates, and there are very limited, or no data, on the effect of other medications used for Osteoporosis, including the use of denosumab. This study will focus on the evaluation of the efficacy and safety of denosumab 60mg use early (within first 3 months) after Liver Transplantation in the management of bone loss and prevention of fragility fractures. Different tests will be used to study the effect of the medication on the skeleton, including imaging studies as well as specific labwork.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Use of denosumab in post liver transplant patient for prevention and management of osteoporosis and bone loss.
Use of placebo in post liver transplant patient for prevention and management of osteoporosis and bone loss.
The percentage changes in bone mass calculated by DEXA scan t-score of Lumbar Spine in the intervention and control groups at 12 months.
Time frame: 12 months
The percentage changes in bone mass calculated by DEXA scan t-score of Femoral Neck, Total Hip and Wrist in the intervention and control groups at 12 months.
Time frame: 12 months
The percentage changes in bone mass calculated by DEXA scan t-score of Lumbar Spine, Femoral Neck, Total Hip and Wrist in the intervention and control groups at 24 months.
Time frame: 24 months
The vertebral and non-vertebral fracture incidence at 12 and 24 months.
Time frame: 12 and 24 months
The percentage changes of biochemical markers of variables of bone turnover (BSAP, CTX and PINP) from baseline to 6, 12, 18 and 24 months after 1st medication administration.
Time frame: 6, 12, 18 and 24 months
The percentage changes of creatinine, Calcium, Magnesium, Phosphorus, PTH intact and 25-Vit D levels from baseline to 6, 12, 18 and 24 months after the 1st medication administration.
Time frame: 6, 12, 18 and 24 months
The percentage of patients developing infections, rejection episodes, hospitalizations or ED visits during the study period.
Time frame: 24 months
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