A trial comparing denosumab and zoledronic acid for advanced cancer that has spread to the bones (20050244)

Cancer type:

Cancer spread to the bone

Secondary cancers

Status:

Results

Phase:

Phase 3

This trial compared denosumab with zoledronic acid to see which was better at treating advanced cancer that had spread to the bones (bone secondaries).

When cancer spreads to the bone it can make the bone weaker and cause pain. Drugs called bisphosphonates can slow down the damage and reduce pain. Zoledronic acid (Zometa or zoledronate) is a bisphosphonate.

Doctors usually prescribe zoledronic acid for secondary cancer in the bones. But researchers thought that a new drug called denosumab may also slow down bone damage, helping to reduce complications, such as cracked or broken bones (fractures) and spinal cord compression Open a glossary item , and the need for radiotherapy and surgery . Denosumab is a type of biological therapy called a monoclonal antibody.

The aim of this trial was to find out whether denosumab worked as well as zoledronic acid for cancer that had spread to the bones. The researchers also wanted to compare the side effects of these 2 treatments.

Summary of results

The trial team found that there was not much difference between denosumab and zoledronic acid for treating advanced cancer that had spread to the bones.

This trial recruited 1,776 people. They were put into 1 of 2 groups by a computer. This is called randomisation. Neither the people nor their doctor knew which group they were in. This is called a double blind trial.

Half the people had denosumab as an injection under their skin and a dummy drug (placebo) as a drip into their vein every 4 weeks.

The other half had zoledronic acid as a drip into their vein and a dummy drug as an injection under their skin every 4 weeks.

The research team looked at when people developed problems with their bones that required medical attention. These are called skeletal related events and include

A broken or cracked bone - fracture
Radiotherapy to the bone
Surgery to the bone
Pressure on your spinal cord from the cancer (spinal cord compression)

The average time it took for people having denosumab to develop skeletal related events was just over 20 and a half months.

The average time it took for people having zoledronic acid to develop skeletal related events was just under 16 and a half months.

There was little difference between the side effects of denosumab and zoledronic acid.

The trial team concluded that for people with advanced cancer, denosumab works just as well as zoledronic acid in slowing down development of bone problems related to cancer.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves