The Effect of Zoledronate on the Prevention of Pneumonia in Hip Fracture Patients (Zoo-P): An Open-label, Pragmatic, Randomised Controlled Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Hong Kong Special Administrative Region
Queen Mary Hospital
RECRUITING
Hong Kong
United Christian Hospital
RECRUITING
Kwun Tong
Caritas Medical Centre
RECRUITING
Sham Shui Po
Prince of Wales Hospital
NOT_YET_RECRUITING
Shatin
Tai Po Hospital
RECRUITING
Tai Po
Contact Information
Primary
Ching-Lung Cheung, PhD
lung1212@hku.hk
+852 2831-5080
Time Frame
Start Date: 2022-12-05
Estimated Completion Date: 2025-06
Participants
Target number of participants: 2692
Treatments
Experimental: Zoledronate
Zoledronate intravenous infusion (5mg) once and usual care will be provided to the patient and mark the start of 12-month follow-up period
No_intervention: Control
Only usual care will be provided to the patient with 12-month follow-up period.
Sponsors
Collaborators: Prince of Wales Hospital, Shatin, Hong Kong, Queen Mary Hospital, Hong Kong, Caritas Medical Centre, Hong Kong, United Christian Hospital
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov