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A Study to Evaluate Efficacy and Safety of Denosumab for Prevention and Treatment of Osteoporosis in 1st Time Liver Transplant Recipients.

NCT04231682 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-06-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Denosumab Injection

Use of denosumab in post liver transplant patient for prevention and management of osteoporosis and bone loss.

DRUG

Placebos

Use of placebo in post liver transplant patient for prevention and management of osteoporosis and bone loss.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Albert Einstein Healthcare Network

    lead OTHER

Principal Investigators

  • Catherine Anastasopoulou, MD, PhD · Einstein Medical Center Philadelphia.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2024-01-01
Completion
2025-01-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04231682 on ClinicalTrials.gov