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NCT04231682WITHDRAWNanonymous

A Prospective Randomized Double-Blind, Placebo-Controlled Phase 2 Study Evaluating the Efficacy and Safety of Early Administration of Denosumab 60mg for Prevention and Treatment of Osteoporosis in First-time Liver Transplant Recipients

Sponsor

Source record

Albert Einstein Healthcare Network

Phase

Source record

PHASE2

Modality

AI-normalized

small molecule

Target

AI-normalized

Denosumab Injection, Placebos

Indication / condition

AI-normalized

Osteoporosis

Intervention

Source record

Denosumab Injection, Placebos

Source & freshness

Source record

NCT ID

NCT04231682

Original source

ClinicalTrials.gov

Source last updated

Jun 26, 2020

Ingested at

Jun 19, 2026

Internal sync

Jun 19, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT04231682

Title

A Prospective Randomized Double-Blind, Placebo-Controlled Phase 2 Study Evaluating the Efficacy and Safety of Early Administration of Denosumab 60mg for Prevention and Treatment of Osteoporosis in First-time Liver Transplant Recipients

Sponsor

Albert Einstein Healthcare Network

Status

WITHDRAWN

Phase

PHASE2

Condition raw

Osteoporosis

Condition normalized

Osteoporosis

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Denosumab Injection, Placebos

Target normalized

Denosumab Injection, Placebos

Interventions

Denosumab Injection, Placebos

Public preview

Source record

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.

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