Preventing Bone Loss in Critically Ill Adults Using Denosumab or Zoledronic Acid A Phase II Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the effect of denosumab and zoledronic acid compared to a placebo on bone mineral density in adults who have been critically ill. The trial focuses on women aged 50 years or older and men aged 70 years or older who have been admitted to intensive care for more than 24 hours. This study addresses the problem of accelerated bone loss and increased fracture risk after critical illness, particularly in older adults. Participants will be randomly assigned to one of three groups the denosumab group, which receives 60mg via subcutaneous injection on days 1 and 180 the zoledronic acid group, which receives a 5mg intravenous infusion on day 1 or the placebo group, which receives matching placebo injections and infusions on the same schedule. These treatments are administered during the year following intensive care admission to assess their impact on preventing bone loss. During the study, participants will have their bone mineral density measured at the femoral neck and lumbar spine over 12 months. Researchers will also monitor fractures, falls, hospital readmissions, mortality, and quality of life at various points up to one year. Additional bone turnover markers will be evaluated in a sub-study. The total participation period lasts one year with safety and outcome assessments throughout.

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