Evidence map›Paper›PMID 38267490›Full record

Trial reportScientific reports2024

A pilot feasibility randomised controlled trial of bone antiresorptive agents on bone turnover markers in critically ill women.

Neil R Orford, Allison Bone, Mark A Kotowicz, Michael Bailey, Julie A Pasco, Matthew Maiden, Nima Kakho, Claire Cattigan, Martina Nichonghaile, Claire Jones and 4 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.4field-weighted citation impact, top 24% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Protocol summary and statistical analysis plan for the bone loss prevention with zoledronic acid or denosumab in critically ill adults (BONE ZONE) trial.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2026
    Article
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

14 authors at 5 institutions in 1 country.

Neil R OrfordIntensive Care Unit, University Hospital Geelong, Barwon Health, Geelong, Australia. n.orford@deakin.edu.au.ORCID 0000-0002-2285-9233
Allison BoneIntensive Care Unit, University Hospital Geelong, Barwon Health, Geelong, Australia.
Mark A KotowiczIMPACT-Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Deakin University, Geelong, Australia.
Michael BaileyAustralian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine (SPPHPM), Monash University, Melbourne, Australia.
Julie A PascoIMPACT-Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Deakin University, Geelong, Australia.
Matthew MaidenIntensive Care Unit, University Hospital Geelong, Barwon Health, Geelong, Australia.
Nima KakhoIntensive Care Unit, University Hospital Geelong, Barwon Health, Geelong, Australia.
Claire CattiganIntensive Care Unit, University Hospital Geelong, Barwon Health, Geelong, Australia.
Martina NichonghaileIntensive Care Unit, University Hospital Geelong, Barwon Health, Geelong, Australia.
Claire JonesIntensive Care Unit, University Hospital Geelong, Barwon Health, Geelong, Australia.
Carol HodgsonAustralian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine (SPPHPM), Monash University, Melbourne, Australia.
Priya NairIntensive Care Unit, St Vincent's Hospital Sydney, Sydney, Australia.
Jacqueline CenterIntensive Care Unit, St Vincent's Hospital Sydney, Sydney, Australia.
Rinaldo BellomoAustralian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine (SPPHPM), Monash University, Melbourne, Australia.
Barwon Health · AUAustralian and New Zealand Intensive Care Society · AUDeakin University · AUGarvan Institute of Medical Research · AUThe University of Melbourne · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Critical illness is associated with increased bone turnover, loss of bone density, and increased risk of fragility fractures. The impact of bone antiresorptive agents in this population is not established. This trial examined the efficacy, feasibility, and safety of antiresorptive agents administered to critically ill women aged fifty years or greater. Women aged 50 years or greater admitted to an intensive care unit for at least 24 h were randomised to receive an antiresorptive agent (zoledronic acid or denosumab) or placebo, during critical illness and six months later (denosumab only). Bone turnover markers and bone mineral density (BMD) were monitored for 1 year. We studied 18 patients over 35 months before stopping the study due to the COVID-19 pandemic. Antiresorptive medications decreased the bone turnover marker type 1 cross-linked c-telopeptide (CTX) from day 0 to 28 by 43% (± 40%), compared to an increase of 26% (± 55%) observed with placebo (absolute difference - 69%, 95% CI - 127% to - 11%), p = 0.03). Mixed linear modelling revealed differences in the month after trial drug administration between the groups in serum CTX, alkaline phosphatase, parathyroid hormone, and phosphate. Change in BMD between antiresorptive and placebo groups was not statistically analysed due to small numbers. No serious adverse events were recorded. In critically ill women aged 50-years and over, antiresorptive agents suppressed bone resorption markers without serious adverse events. However, recruitment was slow. Further phase 2 trials examining the efficacy of these agents are warranted and should address barriers to enrolment.Trial registration: ACTRN12617000545369, registered 18th April 2017.

Indexed as

Bone Density Conservation AgentsBone RemodelingCritical IllnessDenosumabFeasibility StudiesFemaleHumansPandemicsBone Density Conservation AgentsDenosumab

Identifiers

PMID38267490
PMCPMC10810087
OpenAlexW4391175456

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.