A study looking at the bone health in women who took part in the AZURE trial

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Other

This study is looking at possible side effects of zoledronic acid, in women who took part in the AZURE trial. The AZURE trial is trying to find out if zoledronic acid helps to stop breast cancer coming back.

More about this trial

Zoledronic acid is a type of drug called a bisphosphonate. It is used to treat osteoporosis Open a glossary item . If you have breast cancer that has spread to your bones, you may have it to prevent or reduce bone damage.

If the AZURE trial finds that zoledronic acid lowers the risk of the cancer coming back, it is likely that the drug will become part of standard treatment Open a glossary item .

It is likely that zoledronic acid will strengthen the bones and prevent fractures. However, researchers in this study need to check that this is the case and find out how long the treatment works for. Also, because the drug has been given more often than usually recommended to treat osteoporosis, they want to find out more about the effects on bone health in the five years after treatment is completed. This study is looking at women who took part in the AZURE trial, comparing those who did and didn’t have zoledronic acid as part of their treatment. The main aims of this study are to

See if zoledronic acid given in the AZURE trial has a positive effect on how strong and thick (dense) the bones are, and how long this lasts
See how quickly the bone repairs and renews itself

Who can enter

You can enter this study if you

Have taken part in the AZURE trial in the UK, and are in the first 3 months of the 5 year follow up period
Would be able to have the study scan to measure the thickness and strength of your bones (a DXA scan) within the first 3 months of this follow up period

You cannot enter this study if

You have breast cancer that has spread to another part of your body, or has come back after treatment
You have had treatment with bisphosphonates apart from in the AZURE trial
Your medical history means that the DXA scan may give misleading results, for example you have had surgery to an area being scanned – you can check this with your doctor
You are pregnant or breastfeeding
You have any other condition that would make you unwell if you took part, or affect the results of the study – you can check this with your doctor

Trial design

This study will recruit 224 women.

Everyone will have 4 bone density (DXA) scans, a series of blood and urine tests and complete a questionnaire about their bone health over the next 5 years.

The bone scan in this study is a simple procedure, and you will not need to have any injections. It is a bit like having an X-ray. You do not usually have to get undressed. For the scan, you lie on the scanning table so that measurements can be made of your spine and hips. The person operating the scan will stay with you for the length of the scan, which is about 20 minutes.

For each blood sample you give, the team will collect about 2 dessert spoons of blood. The team will also give you a special container to collect a urine sample at these appointments.

The questionnaire will ask you about your bone health, for example any fractures you may have had, and should not take long to complete.

The team will also ask about 20 people who had zoledronic acid in the AZURE trial, and 20 people who didn’t, to take part in an extra scan study. This second scan is called a ‘quantitative bone scan’. Healthy bones are constantly remodelling themselves, with specialised cells forming and absorbing bone. These processes are balanced to keep the bones healthy and strong. A quantitative bone scan can check to see if zoledronic acid stops the bone breaking down when the body needs it to break down.

For the quantitative bone scan, you will have an injection of a small amount of radioactive dye to show up your bones under a special camera. You then lie on a bed and the camera will move over your body from head to foot. You have 4 of these scans, which last about 5 minutes each. Four hours after your dye injection you then have a normal bone scan, which will last about half an hour.

As well as these scans, the team will put a small plastic tube into a vein in your arm so they can take 7 blood samples at different times during your appointment. The team will look at these samples to measure the amount of new bone formed in your skeleton. After your study scans and blood tests, you then go home.

You will also give further blood and urine samples for this part of the study.

For both the main study, and this quantitative study, you have the scans
when you start the study, and at 1, 2 and 5 years.

Although looking for cancer is not the aim of the study, it is possible that the quantitative bone scan could tell doctors if your breast cancer has spread to your bones. While this would be unlikely, if this happened you would not be able to carry on with the study. Instead, you would see your breast cancer specialist, who would arrange more tests for you and talk to you about further treatment.

Hospital visits

Because you are already taking part in the AZURE trial, you have agreed to come to clinic every year for the 5 years after you finished the treatment part of the study. You will have your scans and most of your blood and urine tests at these visits.

You will need to make one extra visit at 6 months for some blood and urine tests.

As far as possible, the team will make sure that, if you do have to come for any other visits, these will be as few as possible.

Side effects

The amount of radiation you would get from the DXA scans is very small. We are all exposed to a very small amount of radiation during the course of a normal day (background radiation). The total amount of radiation you would have from the DXA scans is about the same as a few weeks of background radiation.

The amount of radiation you would have from the quantitative bone scans would be the same as about 6 years background radiation.