Sign inCreate account

Report workspace

Add to folder
NCT05096195ACTIVE_NOT_RECRUITINGanonymous

Denosumab for the Prevention of Fragility Fractures in Hemodialysis: a Pilot Study for an Innovative, Randomized-controlled Trial, Embedded in Routine Care

Sponsor

Source record

Western University, Canada

Phase

Source record

PHASE4

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Denosumab 60 mg/ml, Calcium and vitamin D prophylaxis, Monitoring of post-injection calcium and phosphate

Indication / condition

AI-normalized

Kidney Diseases

Intervention

Source record

Denosumab 60 mg/ml, Calcium and vitamin D prophylaxis, Monitoring of post-injection calcium and phosphate

Related intelligence directories

Indication directory: Kidney DiseasesModality directory: monoclonal antibodyTarget directory: Denosumab 60 mg/ml

Source & freshness

Source record

NCT ID

NCT05096195

Original source

ClinicalTrials.gov

Source last updated

May 31, 2025

Ingested at

Jun 19, 2026

Internal sync

Jun 19, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT05096195

Title

Denosumab for the Prevention of Fragility Fractures in Hemodialysis: a Pilot Study for an Innovative, Randomized-controlled Trial, Embedded in Routine Care

Sponsor

Western University, Canada

Status

ACTIVE_NOT_RECRUITING

Phase

PHASE4

Condition raw

Kidney Diseases, Dialysis; Complications, Fragility Fracture, Chronic Kidney Disease-Mineral and Bone Disorder

Condition normalized

Kidney Diseases, Dialysis; Complications, Fragility Fracture, Chronic Kidney Disease-Mineral and Bone Disorder

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

Denosumab 60 mg/ml, Calcium and vitamin D prophylaxis, Monitoring of post-injection calcium and phosphate

Target normalized

Denosumab 60 mg/ml, Calcium and vitamin D prophylaxis, Monitoring of post-injection calcium and phosphate

Interventions

Denosumab 60 mg/ml, Calcium and vitamin D prophylaxis, Monitoring of post-injection calcium and phosphate

Public preview

Source record

PREFERRED-1 is a pilot study designed to determine the feasibility of a large randomized, pragmatic, open-label, comparative-effectiveness trial of denosumab for the prevention of fragility fractures in people receiving hemodialysis. The pilot study will enroll at least 60 patients from across at least 6 different hemodialysis centres in Ontario, Canada. Patients on outpatient maintenance hemodialysis at high risk of fragility fracture, will be randomized 1:1 to a denosumab care pathway vs. usual care.

Primary outcomes include recruitment feasibility and treatment adherence. Secondary outcomes include safety and participant satisfaction with our protocol and processes.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

Report access

Create an account to unlock this report

Choose the access model that matches the job: one urgent report, reusable credits for project work, or unlimited monthly access with AI and folders.

Early access offer

Subscribe with code FOUNDERS5 for a 5-day premium trial.

Full protocol, outcomes, eligibility, contacts and results sections
Patent/IP landscape with verified records when available
Board-ready PDF export with source provenance
Save to folders and synthesize multiple assets in premium workspace
Create account
Sign in

Create a free account first, then unlock a single report, buy credits or subscribe.

TrialSignal

Clinical trial intelligence report

Denosumab for the Prevention of Fragility Fractures in Hemodialysis: a Pilot Study for an Innovative, Randomized-controlled Trial, Embedded in Routine Care

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 19, 2026

NCT ID

NCT05096195

Status

ACTIVE_NOT_RECRUITING

Phase

PHASE4

Sponsor

Western University, Canada

Executive brief

Investment-Ready Snapshot

PREFERRED-1 is a pilot study designed to determine the feasibility of a large randomized, pragmatic, open-label, comparative-effectiveness trial of denosumab for the prevention of fragility fractures in people receiving hemodialysis. The pilot study will enroll at least 60 patients from across at least 6 different hemodialysis centres in Ontario, Canada. Patients on outpatient maintenance hemodialysis at high risk of fragility fracture, will be randomized 1:1 to a denosumab care pathway vs. usual care. Primary outcomes include recruitment feasibility and treatment adherence. Secondary outcomes include safety and participant satisfaction with our protocol and processes.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedMay 31, 2025
Internal syncJun 19, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT05096195

Indication

Kidney Diseases

Modality

monoclonal antibody

Target

Denosumab 60 mg/ml, Calcium and vitamin D prophylaxis, Monitoring of post-injection calcium and phosphate

Intervention

Denosumab 60 mg/ml, Calcium and vitamin D prophylaxis, Monitoring of post-injection calcium and phosphate

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.