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

NCT05743179 | Recruiting Phase 4

• 1 other identifier: Zoo-P_001
• Study Type: interventional
• Target: 2,692
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Hip Fractures; Pneumonia

Keywords

Zoledronic Acid; Pneumonia; Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Pneumonia hospitalizations

  Diagnosis records of pneumonia from electronic medical records

  12 months

Secondary Outcomes (4)

• Cardiovascular events

  12 months

• Refracture events

  12 months

• Problems associated with fracture healing, including revision surgery

  12 months

• All-cause mortality

  12 months

Study Arms (2)

Zoledronate

EXPERIMENTAL

Zoledronate intravenous infusion (5mg) once and usual care will be provided to the patient and mark the start of 12-month follow-up period

Drug: Zoledronate

Control

NO INTERVENTION

Only usual care will be provided to the patient with 12-month follow-up period.

Interventions

Zoledronate DRUG

Aclasta Solution for Infusion 5mg/100ml (zoledronic acid)

Also known as: Zoledronic acid, Aclasta

Zoledronate

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator
• Caritas Medical Centre, Hong Kong: collaborator
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator
• United Christian Hospital: collaborator

Study Sites (5)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

United Christian Hospital

Kwun Tong, Hong Kong

RECRUITING

Caritas Medical Centre

Sham Shui Po, Hong Kong

RECRUITING

Prince of Wales Hospital

Shatin, Hong Kong

NOT YET RECRUITING

Tai Po Hospital

Tai Po, Hong Kong

RECRUITING

MeSH Terms

Conditions

Hip Fractures; Pneumonia

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kathryn Tan, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching-Lung Cheung, PhD

CONTACT

+852 2831-5080; lung1212@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 24, 2023
• Study Start: December 5, 2022
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (5)