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Zoledronate Early to Hip Fracture Patients - Safe and Effective?

NCT05025293 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-04-02

No results posted yet for this study

Summary

To prevent hip fracture patients for having another fracture, secondary fracture preventing medication should be given as soon as possible. Zoledronate is the most efficient bisphosphonate and is given as an intravenous infusion once yearly. However, the appropriate time to initiate zoledronate treatment after a hip fracture has not yet been established. To clarify the optimal timing of zoledronate to hip fracture patients we have designed a double-blinded, placebo-controlled randomized non-inferiority trial to compare if zoledronate administered early (within 5 days) after hip fracture surgery is as good as zoledronate given late (3 months) after hip fracture surgery.

Conditions

Interventions

DRUG

Zoledronic Acid 5Mg/Bag 100Ml Inj

100ml Zoledronic acid (5mg/100ml) administered intravenously

DRUG

sodium chloride

100ml NaCl 9mg/ml administered intravenously

Sponsors & Collaborators

  • Vestre Viken Hospital Trust

    collaborator OTHER

  • Roche Diagnostics GmbH

    collaborator INDUSTRY

  • Diakonhjemmet Hospital

    collaborator OTHER

  • Lene Bergendal Solberg

    lead OTHER

Principal Investigators

  • Solberg B Lene, PhD MD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05025293 on ClinicalTrials.gov