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NCT05743179
The Effect of Zoledronate on the Prevention of Pneumonia in Hip Fracture Patients
Conditions: Hip Fractures, Pneumonia
Sex: All
Ages: 60 Years – N/A
Phase: PHASE4
Enrollment: 2692
Sponsor: The University of Hong Kong
Location: Hong Kong
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.
Eligibility Criteria
Inclusion Criteria:Male or female ≥ 60 yearsWith recent fragility hip fracture at proximal femurHave 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 formExclusion Criteria:Known to be hypersensitive to any N-BPsEstimated glomerular filtration rate (eGFR) < 30 ml per minute per 1.73 m2 of body surface areaRegular 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
Source: ClinicalTrials.gov (NCT05743179). StuddyBuddy aggregates publicly available trial information.