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Study on Zoledronic Acid for Patients with Hip Fractures: Evaluating Early Treatment Safety and Effectiveness

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication Zoledronic Acid in patients who have experienced a hip fracture. The trial is known as the ZEBRA trial. Zoledronic Acid is a type of medication called a bisphosphonate, which is used to help strengthen bones. In this study, the medication will be given to patients through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to determine if giving Zoledronic Acid early, within 5 days after hip fracture surgery, is as effective as giving it later, 3 months after surgery. The study will monitor the effects of the medication on bone health over a period of 12 months. Participants will be randomly assigned to receive either the early or late treatment, and some may receive a placebo. The study will also involve monitoring various health outcomes, such as the ability to move around, the occurrence of delirium, and any changes in bone density.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how the treatment affects their recovery from a hip fracture. The trial aims to provide valuable insights into the best timing for administering Zoledronic Acid to improve bone health and recovery in patients with hip fractures. The study is expected to continue until June 2026.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, eligibility is confirmed based on criteria such as age, hip fracture type, and kidney function.

    Informed consent is required, either from the patient or a next of kin.

  2. Step 2

    Surgery and initial treatment

    Surgery for the hip fracture is performed within 72 hours of the fracture.

    Post-surgery, the patient is monitored for early mobilization and any signs of delirium.

  3. Step 3

    Administration of zoledronic acid

    Zoledronic acid is administered through an intravenous infusion.

    The timing of the infusion is randomized: either within 5 days after surgery or 3 months post-surgery.

  4. Step 4

    Monitoring and follow-up

    The patient's bone health is assessed by measuring bone turnover markers, such as P1NP, 12 months after treatment.

    Secondary assessments include mobilization scores, incidence of fever, antibiotic use, and any new fractures or hospital readmissions.

  5. Step 5

    Completion of the trial

    The trial is expected to conclude by June 2026.

    Final evaluations will determine the effectiveness and safety of early versus late administration of zoledronic acid.

Who can join the trial?

6 criteria

  • The patient must have had one **low energy hip fracture**. This means the fracture happened from a minor fall or accident, not a major trauma.
  • The patient must have had **surgery within 72 hours** after the hip fracture.
  • The patient must be **over 50 years old**. If the patient is a woman aged 50-60, she must be **postmenopausal** (no longer having menstrual periods) or not pregnant.
  • The patient must have **acceptable kidney function**. This is measured by something called **estimated GFR**, which should be greater than 35. The patient should also have normal **calcium levels** in the blood.
  • The patient must be considered **fit to complete the follow-up** by the doctor in charge of recruiting for the study. This means the patient is healthy enough to participate in all parts of the study.
  • The patient or their next of kin must have **signed informed consent**. This means they agree to participate in the study after understanding what it involves.

Who cannot join the trial?

4 criteria

  • Patients who have had a hip fracture cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Both male and female patients are considered, but specific criteria may exclude some based on gender-related factors.
  • Patients who are part of a vulnerable population are not eligible. This means people who might need special protection or care.
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Investigated drugs

Zoledronate is a medication used in this trial to help patients who have had hip fractures. It is given to see if it can effectively reduce bone turnover, which is a process where old bone is replaced by new bone. The trial is testing whether giving zoledronate early, within 5 days after hip fracture surgery, is as effective as giving it later, 3 months after surgery. The goal is to see if early treatment can help maintain bone strength and prevent further fractures.

What is already known about the treatment

Zoledronate – Zoledronate is administered intravenously, typically as an infusion. It is currently being studied in clinical trials for its effectiveness and safety in patients with hip fractures. The main therapeutic indication for zoledronate is to strengthen bones and reduce the risk of fractures, particularly in conditions like osteoporosis. At the molecular level, zoledronate works by inhibiting the activity of osteoclasts, the cells responsible for bone resorption, thereby reducing bone turnover. It is classified pharmacologically as a bisphosphonate, a group of drugs known for their role in managing bone density disorders.

Investigated diseases

Hip Fracture – A hip fracture is a break in the upper part of the thigh bone (femur) near the hip joint. It often occurs in older adults, especially those with weakened bones due to osteoporosis. The fracture typically results from a fall or direct impact to the hip area. Symptoms include severe pain in the hip or groin, inability to put weight on the leg, and stiffness or bruising around the hip. The condition can lead to complications such as reduced mobility and increased risk of further fractures. Recovery often involves surgery followed by rehabilitation to restore movement and strength.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510198-32-00Estimated enrolment300 patientsSponsorOslo University Hospital HF

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