Health TrialsbyHealthPanel

Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults

ConditionsCritical IllnessOsteoporosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorAustralian and New Zealand Intensive Care Research Centre

About this trial

The Bone Zone trial is a prospective, multi-centre, double-blind, phase II, randomised controlled trial evaluating the effect of denosumab or zoledronic acid compared to placebo on change in bone mineral density over one year in women aged 50 years or older and men aged 70 years or older requiring admission to intensive care for greater than 24 hours.

450 women aged 50 years or older and men aged 70 years or older, admitted to intensive care for greater than 24 hours will be recruited into the study from participating study centres.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female age ≥ 50 years or male age ≥ 70 years

Has been in the Intensive Care Unit for 2 or more calendar days and is not expected to be discharged from the Intensive Care Unit on the second day

Has required Intensive Care Unit level support (i.e. intravenous vasoactive drugs, or invasive mechanical ventilation, or non-invasive ventilation or high flow nasal oxygen at Fraction inspired Oxygen ≥0.4 and/or gas flows ≥40L/m) for a minimum cumulative duration of 6 hours

Expected to survive the current hospital admission

Disqualifiers

Cancer related metastatic bone disease or multiple myeloma

Paget's disease

Pregnancy

Current estimated Glomerular Filtration Rate <30ml/min or receiving renal replacement therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Denosumab 60 MG/ML

    Drug

    Patients allocated to the Denosumab arm will receive Denosumab 60mg in 1ml, administered via subcutaneous injection on Study Days 1 and 180.

  • Zoledronic Acid 5Mg/Bag 100Ml Inj

    Drug

    Patients allocated to the Zoledronic acid arm will receive Zoledronic acid 5mg in 100ml 0.9% Sodium Chloride or 5% Dextrose, administered via intravenous infusion over at least 15 minutes on Study Day 1.

  • Sodium Chloride 0.9% or 5% Dextrose Intravenous

    Drug

    Patients allocated to the placebo arm and Denosumab arm will receive 0.9% Sodium Chloride or 5% Dextrose 100ml administered via intravenous infusion over at least 15 minutes on Day 1.

  • Sodium Chloride 0.9% Injection

    Drug

    Patients allocated to the placebo arm and Zoledronic acid arm will receive 0.9% Sodium Chloride 1ml administered via subcutaneous injection on Days 1 and Day 180

Treatment groups

450 Participants
are divided into 3 treatment groups
Group A: DenosumabActive comparator 2 interventions
Group B: Zoledronic acidActive comparator 2 interventions
Group C: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Annualised change in femoral neck bone mineral density for the year after Intensive Care discharge

Change in femoral neck bone mineral density T-score between baseline and 12 months

Time frame
12 months

Secondary outcomes

1

Annualised change in lumbar spine bone mineral density for the year after Intensive Care discharge

Change in lumbar spine bone mineral densityT-score between baseline and 12 months

Time frame
12 months
2

Clinical fragility fracture

Self-reported incident clinical fractures obtained at follow-up visits. Information on the date, site, and circumstance of the fracture obtained by interview and X-ray report sought and confirmed by medical report.

Time frame
6 and 12 months
3

Vertebral fracture

Incident vertebral fracture obtained during lateral BMD study

Time frame
12 months
4

Falls

Self-reported falls incidence and frequency

Time frame
6 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Australian and New Zealand Intensive Care Research Centre

Lead sponsor

Source ClinicalTrials.gov
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