Evidence map›Paper›PMID 40935429›Full record

ArticleBMJ open2025

PRevEnting FracturEs in REnal Disease-1 (PREFERRED-1): protocol for a pilot study of a pragmatic, randomised controlled trial of denosumab for the prevention of fragility fractures in haemodialysis.

Kristin K Clemens, Andrea Cowan, Stephanie Dixon, Kyla Naylor, Matthew A Weir, Jenny Thain, Tayyab Khan, Sam Silver, Amber O Molnar, Nabil Sultan and 7 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05096195 (Denosumab for the Prevention of Fragility Fractures in Hemodialysis), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05096195 phase4active not recruitingnot on this map

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

TypeinterventionalSponsorWestern University, CanadaRan2022 to 2025Enrolled60ConditionsKidney Diseases, Dialysis, Complications, Fragility FractureArmsDenosumab 60 mg/ml, Calcium and vitamin D prophylaxis, Monitoring of post-injection calcium and phosphate
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Kristin K ClemensMedicine, Western University, London, Ontario, Canada kristin.clemens@sjhc.london.on.ca.ORCID http://orcid.org/0000-0001-9636-5597
Andrea CowanMedicine, Western University, London, Ontario, Canada.
Stephanie DixonMedicine, Western University, London, Ontario, Canada.
Kyla NaylorMedicine, Western University, London, Ontario, Canada.
Matthew A WeirMedicine, Western University, London, Ontario, Canada.
Jenny ThainMedicine, Western University, London, Ontario, Canada.
Tayyab KhanMedicine, Western University, London, Ontario, Canada.
Sam SilverICES Western, London, Ontario, Canada.
Amber O MolnarICES Western, London, Ontario, Canada.
Nabil SultanMedicine, Western University, London, Ontario, Canada.
Rachel M HoldenNephrology, Kingston Health Sciences Centre, Kingston, Ontario, Canada.
Swapnil HiremathDepartment of Medicine, University of Ottawa, Ottawa, Ontario, Canada.ORCID http://orcid.org/0000-0003-0010-3416
Ron WaldNephrology, St Michael's Hospital, Toronto, Ontario, Canada.
Abhijat KitchluUniversity of Toronto, Toronto, Ontario, Canada.
Jennifer ArnoldLawson Health Sciences Centre Research Institute, London, Ontario, Canada.
Bonnie FieldLawson Health Sciences Centre Research Institute, London, Ontario, Canada.
Amit X GargMedicine, Western University, London, Ontario, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivePatients receiving haemodialysis are at very high risk of fragility fracture, yet there are no proven treatments for fracture prevention. We will advance a pilot study on the feasibility of a large, pragmatic, randomised controlled trial (RCT) of denosumab for fragility fracture prevention in haemodialysis. TRIAL

designPRevEnting FracturEs in REnal Disease-1 is a pragmatic, open-label, pilot study of an RCT of a denosumab care pathway embedded in routine care haemodialysis centres.

methodsWe will recruit at least 60 participants at high risk of fracture from at least 6 haemodialysis centres in Ontario, Canada. They must be aged 40 years or older, have access to provincial drug coverage, have appropriate baseline calcium and parathyroid hormone levels and be deemed suitable for denosumab by their kidney care provider. Participants will be randomised 1:1 to denosumab (with supports to mitigate hypocalcaemia) versus usual care using block randomisation by a central statistician (computer-generated sequence). Primary outcomes include recruitment feasibility and adherence. Secondary outcomes include safety (hypocalcaemia) and participant satisfaction with our protocol and processes. Study investigators and data analysts will be blind to treatment allocation.We will present results descriptively. The trial was approved by Clinical Trials Ontario and local research ethics boards across study sites.

resultsPrimary and secondary outcomes will be published on trial completion.

conclusionsThis pilot will inform the feasibility of conducting a large-scale, efficiently run, pragmatic RCT to test whether a denosumab care pathway safely reduces the risk of fragility fracture in patients receiving haemodialysis. Results have the potential to transform fracture care in real-world patients with kidney and metabolic bone disease. TRIAL REGISTRATION NUMBER: NCT05096195.

Indexed as

Bone Density Conservation AgentsDenosumabOsteoporotic FracturesRenal DialysisAdultFemaleHumansMaleOntarioPilot ProjectsPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicBone Density Conservation AgentsDenosumabDialysisDrug TherapyFeasibility StudiesFractures, BonePragmatic Clinical Trial

Identifiers

PMID40935429
PMCPMC12519385

What Socratic holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.