Preventing bone loss in critically ill adults using medications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of denosumab and zoledronic acid in preventing bone loss in critically ill adults aged 50 and older for women and 70 and older for men, who have been in the Intensive Care Unit (ICU) for more than 24 hours. Participants will be randomly assigned to receive either one of the medications or a placebo, and their bone mineral density will be measured over the course of one year. The study aims to address the significant bone loss that occurs during and after critical illness, which can lead to increased fracture risk. By understanding the impact of these treatments, the trial seeks to improve long-term outcomes for ICU survivors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Cancer related metastatic bone disease or multiple myeloma
* Paget's disease
* Pregnancy
* Current estimated Glomerular Filtration Rate \<30ml/min or receiving renal replacement therapy
* Known contraindication to denosumab or zoledronic acid
* Obvious holes in teeth or broken teeth or dental or gum infection
* Known untreated hypoparathyroidism
* Current treatment with anti-fracture agent (bisphosphonate, strontium or teriparatide within previous 2 years, or menopausal hormone therapy or romosozumab within previous 12-months or denosumab within previous 6 months)
* Current fragility fracture of hip, spine, femur or forearm
* Exceeds weight limit for BMD scan at site or unable to undertake Bone Mineral Density for any reason
* International Normalised Ratio \> 3.0 or Platelet count \< 30 10\^9/L

Where it's running

• St Vincent's Health Sydney
  Sydney, New South Wales, Australia Recruiting
• Prince of Wales Hospital
  Sydney, New South Wales, Australia Recruiting
• Blacktown Hospital
  Sydney, New South Wales, Australia Recruiting
• Royal Prince Alfred Hospital
  Sydney, New South Wales, Australia Recruiting
• Wollongong Hospital, Illawarra Shoalhaven Health
  Wollongong, New South Wales, Australia Recruiting
• Sunshine Coast University Hospital
  Birtinya, Queensland, Australia Recruiting

Study contacts

• Study coordinator: Allison Bone
• Email: allison.bone@monash.edu
• Phone: +61 3 9903 0343

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ibandronate vs. Zoledronic Acid After Denosumab: Is Either Equal for Postmenopausal Osteoporosis?

  In postmenopausal osteoporosis, this study tests whether intravenous ibandronate given after stopping denosumab works as well as zoledronic acid over a year.

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• Romosozumab and denosumab alone or together for postmenopausal osteoporosis

  This 6-month pilot tests whether cyclic romosozumab combined with denosumab improves bone density more than denosumab alone in postmenopausal women with osteoporosis.

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• Denosumab effects on muscle strength and insulin sensitivity

  This trial will test whether denosumab improves muscle strength and insulin sensitivity in postmenopausal women with osteoporosis and type 2 diabetes who are taking metformin.

  Recruiting Phase 4 Aarhus University Hospital · Aarhus · NCT07271771

• Comparing two treatment regimens for osteoporosis in postmenopausal women

  This study is testing two different treatment plans for osteoporosis in postmenopausal women to see which one helps improve bone strength and reduce the risk of fractures better.

  Recruiting Phase 4 National Taiwan University Hospital · Taipei · NCT06938152

• Evaluating new treatments for osteoporosis after denosumab therapy in Japanese patients

  This study tests different treatment options for Japanese patients with osteoporosis who have been on denosumab for two years to see which one works best and is safe to use for another two years.

  Recruiting Phase 2 Shinshu University · Matsumoto, Nagano · NCT03755193

• Predicting Extubation Problems With Machine Learning

  This study tests whether computer models can predict extubation failure in adults on ventilators in the ICU.

  Recruiting Universitas Indonesia · Jakarta, DKI Jakarta and 1 other locations · NCT07918924

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.