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

Phase 4

Recruiting

• Conditions: Hip Fractures; Pneumonia
• Interventions: Drug: Zoledronate

• Registration Number: NCT05743179
• Lead Sponsor: The University of Hong Kong

Brief 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 m...

Detailed Description

N-BPs are widely used in the treatment of osteoporosis and fracture prevention. Although alendronate is the first-line antiosteoporosis medication in many countries, it is associated with esophageal and gastrointestinal irritation. In addition, the regimen for alendronate is one tablet per week and careful use of alendronate is required to avoid gastrointest...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-12-05
• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2692

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zoledronate	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

Primary Outcome Measures

Name	Time	Method
Pneumonia hospitalizations	12 months	Diagnosis records of pneumonia from electronic medical records

Secondary Outcome Measures

Name	Time	Method
Refracture events	12 months	Diagnosis records of refracture from electronic medical records
Cardiovascular events	12 months	Diagnosis records of cardiovascular events from electronic medical records
Problems associated with fracture healing, including revision surgery	12 months	Diagnosis and operation records from electronic medical records
All-cause mortality	12 months	Date of death and cause of death information from electronic medical records

Trial Locations

Locations (5)

Caritas Medical Centre; 🇭🇰 Sham Shui Po, Hong Kong

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

United Christian Hospital; 🇭🇰 Kwun Tong, Hong Kong

Prince of Wales Hospital; 🇭🇰 Sha Tin, Hong Kong

Tai Po Hospital; 🇭🇰 Tai Po, Hong Kong