Supported Research

General Audience Summary

Preventing bone fractures in hemodialysis with denosumab: a pilot study for a large clinical trial (PREFERRED-1)

Background: One in 10 women and one in 20 men who receive hemodialysis (a treatment for kidney failure which filters waste and water from blood) will suffer a fracture due to brittle bones. “Fragility” fractures not only lead to pain and loss of quality of life, but admissions to hospitals, nursing homes, and even death. Fragility fractures are also extremely costly to our healthcare system.

Purpose: Despite the risk of fragility fracture in hemodialysis, there are no research studies on how to best prevent them in this population. Most "fracture-preventing" medications available for use in those with normal kidneys either can’t be used in hemodialysis, or have severe side effects (e.g heart attack). Although a medication called denosumab (Prolia) is approved for use in dialysis, there have been no large research studies to determine if it can safely and effectively prevent fracture.

Procedure: Our team of doctors, researchers and patients will conduct a clinical trial to learn whether denosumab prevents fractures and can be safely used in adults on hemodialysis. Our trial will be conducted in “real-world” dialysis units, using existing data to capture patient characteristics and outcomes, and will be conducted at a fraction of the cost of a traditional clinical trial. Before conducting our large trial of denosumab, we propose a small "pilot" study (PREFERRED-1) to ensure that a large trial is possible, and that enough patients will participate.

Outcomes: With completion of PREFERRED-1 we will understand how well we can conduct a larger trial examining fracture outcomes with denosumab, an outcome that matters most to patients and providers. We will also explore how safe this medication is in people using hemodialysis.

Relevance to patients: People using hemodialysis are routinely excluded from research studies. They are denied treatments that could improve their care, outcomes and quality of life. PREFERRED-1 will purposively include and study these individuals, and spark the creation of needed knowledge to better care for those with kidney disease. Where people with kidney disease have expressed the desire for healthcare providers to work together and coordinate their healthcare, PREFERRED-1 will also bring together doctors, researchers and patients to study a treatment that can be delivered in a patient-centered manner (i.e. dialysis unit). With patients included as full research partners in PREFERRED-1, they will feel valued, supported and listened to in their healthcare.