The Effect of Zoledronate on the Prevention of Pneumonia in Hip Fracture Patients

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Nitrogen-containing bisphosphonates (N-BPs; such as alendronate and zoledronate) are commonly used in the treatment of osteoporosis and fracture prevention, in which zoledronate has a proven better efficacy than alendronate. In 2018, our real-world propensity score matched study showed that the use of N-BPs was significantly associated with reduced risk of myocardial infarction and stroke in hip fracture patients. In addition to cardiovascular diseases, both preclinical study and sensitivity analysis also suggest evidence for N-BPs in pneumonia prevention. Moreover, a pragmatic clinical trial is developed to evaluate effect of the tested intervention in real-life routine clinical practice since traditional explanatory radomised controlled trial (RCT) may have poor generalizability due to highly selected patients and controlled environments. This study aims to evaluate if zoledronate reduces risk of pneumonia in hip fracture patients using pragmatic clinical trial approach.

This is an open-label, multi-centre, pragmatic, randomised controlled trial. Patients will be recruited from 4 hospitals, namely Caritas Medical Centre, Prince of Wales Hospital, Queen Mary Hospital, and United Christian Hospital. Age, sex, body mass index, eGFR, history of fracture, chronic respiratory diseases, and other medical history, will be measured and recorded at recruitment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Collaborators: Caritas Medical Centre, Hong Kong; Prince of Wales Hospital, Shatin, Hong Kong; Queen Mary Hospital, Hong Kong; United Christian Hospital
• Treatments: Zoledronic Acid

Criteria

Inclusion Criteria:

• Male or female ≥ 60 years

• With recent fragility hip fracture at proximal femur

• Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and discloser of research-related health information, and comply with the study data collection procedures. Provide signed and dated informed consent form

Exclusion Criteria:

• Known to be hypersensitive to any N-BPs

• Estimated glomerular filtration rate (eGFR) < 30 ml per minute per 1.73 m2 of body surface area

• Regular user of anti-osteoporosis medications (including bisphosphonates, denosumab, teriparatides, and raloxifene) or oral or intravenous systemic glucocorticoids in the previous year.

• Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial