Using Zoledronate to Prevent Pneumonia in Hip Fracture Patients
The Effect of Zoledronate on the Prevention of Pneumonia in Hip Fracture Patients (Zoo-P): An Open-label, Pragmatic, Randomised Controlled Trial
This study is testing if giving hip fracture patients a yearly infusion of zoledronate can help prevent pneumonia.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2692 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Drugs / interventions | denosumab |
| Locations | 5 sites (Hong Kong and 4 other locations) |
| Trial ID | NCT05743179 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of zoledronate, a nitrogen-containing bisphosphonate, in reducing the risk of pneumonia among patients who have recently suffered a hip fracture. The study employs a pragmatic clinical trial approach to assess the intervention in real-world clinical settings, addressing the limitations of traditional randomized controlled trials. Participants will receive an annual intravenous infusion of zoledronate, which is known for its efficacy in fracture prevention and potential extra-skeletal benefits. The trial aims to provide insights into the broader health impacts of zoledronate beyond its primary use in osteoporosis treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 60 and older who have recently experienced a fragility hip fracture.
Not a fit: Patients who are hypersensitive to nitrogen-containing bisphosphonates or have severely impaired kidney function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of pneumonia in hip fracture patients, improving their overall health outcomes.
How similar studies have performed: Previous studies have indicated potential benefits of nitrogen-containing bisphosphonates in reducing risks of other health complications, suggesting a promising avenue for this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong and 4 other locations
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
- United Christian Hospital — Kwun Tong, Hong Kong (Recruiting)
- Prince of Wales Hospital — Sha Tin, Hong Kong (Not_yet_recruiting)
- Caritas Medical Centre — Sham Shui Po, Hong Kong (Recruiting)
- Tai Po Hospital — Tai Po, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Kathryn Tan, MD — The University of Hong Kong
- Study coordinator: Ching-Lung Cheung, PhD
- Email: lung1212@hku.hk
- Phone: +852 2831-5080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.