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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. | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

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

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

NCT04231682•Albert Einstein Healthcare Network

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age \>=18 years old
•First-time Liver transplant Recipients
•All men, postmenopausal women and women with history of hysterectomy or tubal ligation
•Patients who have not been treated with medications for Osteoporosis within the past 12 months before the liver transplant
•Patients able and agreeable to follow up at out Institution for the duration of the study
•Patients hospitalized for less than 45 consecutive days after the liver transplant surgery
•Patients with GFR\>30ml/min (calculated by Cockcroft-Gault equation, see Table 3 for details)
•Patients with corrected Calcium \>= 8.5
•Patients with PTH intact levels WNL (as per lab values)
•Patients with vit D\>=20; NOTE: patients with vit D \<20 will be treated with high dose Ergocalciferol 50,000 units daily and rechecked in 2 weeks
+3 more criteria

Exclusion Criteria

•Patients with previous transplants
•Patients that are getting 2 simultaneous transplants, like combined kidney and liver transplants
•Age \< 18 year old
•Patients hospitalized for over 45 days after the liver transplant surgery
•Patients with GFR\< 30ml/min
•Patients with hypocalcemia defined as corrected calcium \< 8.5
•Patients with extensive dental problems, previous hx of Osteonecrosis of the jaw (ONJ) and/or high risk for developing ONJ
•Patients with current Hyperthyroidism
•Patients with current Primary Hyperparathyroidism defined by the combination of elevated calcium and PTH intact levels
•Patients with severe Osteoporosis as defined by t-score \<-3.5 at any site shown by DEXA scan
+4 more criteria

Key Dates

Start Date

July 1, 2020

Primary Completion Date

January 1, 2024

Completion Date

January 1, 2025

Last Updated

June 26, 2020

Conditions

Osteoporosis

Interventions

Denosumab Injection

DRUG

Placebos

DRUG

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

NCT06731608

OsteoporosisLower Limb Fracture

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RECRUITINGPHASE4

Step-down Therapy After Long-term Osteoporosis Treatment

NCT07281586

Osteoporosis

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RECRUITING

Smart Wearable Device (gaitQ): Walk Better Project

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 26, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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.

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

Step-down Therapy After Long-term Osteoporosis Treatment

Smart Wearable Device (gaitQ): Walk Better Project

Automated Bone Age Estimation From Noncontrast Abdominal CT Using Deep Learning

Effect of Mechanical Loading and Bone Loss on Motor Neuron Activity-H-Reflex Relationship

Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device