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Zoledronate Early to Hip Fractures Patients – safe and effective? A Randomized controlled double-blinded treatment strategy trial on Zoledronate in hip fracture patients: The ZEBRA trial

A hip fracture is a serious injury that can make bones weaker and increase the chance of future breaks. Zoledronate is an approved medicine given through a drip to help strengthen bones. Doctors usually wait a few weeks or months after an injury before giving it. The ZEBRA study is investigating whether giving zoledronate earlier, while a person is still in hospital for their hip fracture, is safe and works well. Patients are randomly chosen to receive either zoledronate or a standard fluid drip. Over the following 12 months, researchers will check bone health using blood tests and scans. They will also track how quickly patients can stand and walk, how long they stay in hospital, and whether they experience fewer future fractures or complications like confusion and infections. The findings will help doctors decide the best time to treat broken hips in the future.

At a glance

Status
Recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Oslo University Hospital HF
Enrolment target
300
Start
19 Jun 2024

What is this study about?

A broken hip is a painful and life-changing injury that usually needs surgery and time in hospital to recover. After a hip fracture, bones are often fragile, which raises the risk of breaking another bone. To help protect against this, doctors frequently use bone-strengthening drugs known as bisphosphonates. One common option is zoledronate (also called zoledronic acid), a medicine given once a year through a quick drip into a vein.

At the moment, doctors are not completely certain about the ideal time to start this treatment. Some prefer to wait several weeks after surgery so the body has time to heal from the operation. Others believe that giving the medicine early, while a patient is still in hospital, provides quicker protection and makes sure people do not miss out on vital bone therapy once they return home. The ZEBRA study was designed to compare these approaches and find the safest, most effective routine.

Throughout the study, the research team closely tracks your bone healing and recovery for a full year. They will test your blood to see how actively your bones are rebuilding, measure your bone density with scans, and check how easily and quickly you can get back on your feet. They will also look at safety, recording any fevers, memory confusion, or need for readmission to hospital. The ultimate aim is to improve standard NHS care so that people recovering from hip fractures can regain their independence safely.

Key takeaways

  • The ZEBRA trial tests whether giving zoledronate early after a hip fracture is safe and helps bones recover.
  • Participants receive either the active bone medicine or a standard fluid drip via a vein while in hospital.
  • Researchers will track bone healing, mobility, and recovery for 12 months using blood tests and walking checks.
  • The study checks for side effects such as fever, temporary confusion, or hospital readmissions.
  • Joining is completely voluntary, and leaving the trial will not affect your ongoing NHS care.

Who may be eligible?

This study is designed for adults aged 18 and older who have been admitted to hospital with a hip fracture. It is open to both men and women from all backgrounds.

Because the study investigates early treatment right after surgery, you would normally be invited to take part while you are already staying on the hospital ward for your broken hip.

Before taking part, the hospital doctors will check your general medical history. They will make sure your kidneys are working well enough and that you are healthy enough to receive bone-strengthening medication safely.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am aged 18 or older.
  2. I have recently suffered a broken hip (hip fracture).
  3. I am currently staying in hospital or scheduled for hip fracture surgery.
  4. My doctors consider me medically stable enough to take part in clinical research.
Answer every question to see your result.

What does participation involve?

If you take part, you will be placed into one of two groups by chance (like flipping a coin). One group receives zoledronate through a drip into a vein, while the other group receives a drip containing standard fluids (electrolytes). Neither you nor your doctors will know which drip you received, ensuring the study results are fair.

While you are in hospital, staff will check your temperature, your recovery, and your thinking using simple questions to check for temporary confusion. They will also see how well you can move around using gentle mobility checks.

After leaving hospital, you will have follow-up reviews over the course of 12 months. This includes a walking and mobility check at around 3 months, routine blood tests to look at bone markers, and a bone density scan (DEXA scan) at 12 months. You will not need to pay for any study medicine, and taking part lasts about one year in total.

Potential risks and benefits

Taking part may help improve your bone strength and reduce the chance of future broken bones, although this cannot be guaranteed. You will also receive extra monitoring from the hospital team during your recovery. Like all medicines, zoledronate can cause mild, short-term side effects such as flu-like symptoms, mild fever, or headache, which usually pass in a few days. You are free to leave the study at any time without giving a reason, and deciding to withdraw will never affect your standard NHS medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Norway

Common questions

What is zoledronate?

Zoledronate is a well-known medicine that slows down bone loss and helps rebuild bone strength. It is given through a needle into a vein, usually taking around 15 minutes.

Will I definitely receive the study medicine?

No. You will have an equal chance of receiving either zoledronate or an electrolyte fluid drip. This comparison helps researchers see if early treatment is truly effective.

Will taking part delay my hip surgery?

No. Your normal surgery and essential hospital care will always take priority and will not be delayed by taking part in this trial.

What happens if I feel unwell after the drip?

Hospital staff will monitor you closely. Some people get mild flu-like symptoms or a slight fever, which can usually be treated easily with simple painkillers like paracetamol.

Can I leave the study if I change my mind?

Yes, you can withdraw at any point. Your decision will be fully respected and will not change the quality of your regular NHS treatment in any way.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Zoledronate Early to Hip Fractures Patients – safe and effec…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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