Active not recruitingPHASE3INTERVENTIONAL

Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks

This research study is about Denosumab, a medication used to help prevent bone problems in people whose breast or prostate cancer has spread to their bones. Currently, Denosumab is given every four weeks. This study wants to find out if giving it less often – every 12 weeks instead – is just as effective. Giving Denosumab less frequently could mean fewer trips to the hospital, potentially fewer side effects, and lower costs. Researchers will be carefully checking if the benefits of preventing bone breaks or pain are still there, while also looking at safety, quality of life, and how this new schedule might affect health resources. This is an important step to see if we can improve care while keeping patients safe and comfortable.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Swiss Cancer Institute

Enrolment target

1,380

Start

16 Jul 2014

Estimated completion

31 Dec 2028

Metastatic Breast Cancer Metastatic Prostate Cancer Bone Metastases

What is this study about?

When breast or prostate cancer spreads to the bones, it can cause problems like pain, weakness, and even bone breaks. Denosumab is a medicine that helps to make bones stronger and prevent these issues. It works by stopping certain cells called osteoclasts, which break down bone, from doing their job too much.

Right now, Denosumab is usually given by injection every four weeks. While it's good at what it does, some people might experience side effects, such as issues with their jawbone (though this is rare) or low calcium levels. Also, coming to the clinic every four weeks can be a lot for patients, and the medicine itself is quite expensive. This study is exploring a new way of giving the medicine, to see if it can be given less often – specifically, every 12 weeks instead of every 4 weeks – and still provide the same important benefits.

The main goal is to see if giving Denosumab every 12 weeks is just as good at preventing serious bone problems like fractures or the need for bone treatment, compared to the usual every four weeks schedule. The study will also be carefully watching for any side effects, looking at how it affects patients' quality of life, and checking the costs, to make sure any changes keep patients safe and healthy.

Key takeaways

This study evaluates if Denosumab can be given less often (every 12 weeks) but still be effective.
It's for people with advanced breast or prostate cancer that has spread to their bones.
The goal is to prevent bone problems like fractures and reduce potential side effects.
Participants will be closely monitored for safety and quality of life.
The study hopes to find a way to improve treatment convenience and efficiency.

Who may be eligible?

To join this study, you would need to have breast or prostate cancer that has spread to your bones. For prostate cancer, your disease must be progressing even with ongoing hormone treatment. You also need to have at least three areas of cancer spread in your bones that have been recently confirmed with scans.

You should be aged 18 or over and generally well enough to take part, meaning you can mostly look after yourself. Your blood test results, including calcium, liver function, and kidney function, need to be within a certain healthy range. Women who could become pregnant must not be pregnant, agree to use effective birth control, and not breastfeed. Men should also agree not to father a child during the study and for 12 months afterwards.

However, you cannot join if you have certain conditions, like a very low calcium level that cannot be easily fixed, or if you have a history of jawbone problems (osteonecrosis of the jaw) or unhealed sores in your mouth. These are important checks to make sure the study is safe for everyone involved.

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.

Do you have breast or prostate cancer that has spread to your bones?
Are you 18 years old or older?
Do you generally feel well and able to perform daily activities?
Do you have at least three areas of cancer in your bones confirmed by recent scans?
Are your blood test results for calcium and liver/kidney function within a healthy range?
Do you not have a history of jawbone problems or unhealed mouth sores?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to receive Denosumab either every 4 weeks (standard dosing) or every 12 weeks (reduced dosing). This means a computer will choose which group you are in, like flipping a coin. You will receive Denosumab, a medicine given as an injection, for the duration of the study.

The study will involve regular visits to the clinic for your injections and check-ups. During these visits, the study team will monitor your health closely, perform blood tests, and ask questions about how you are feeling and your quality of life. They will also keep track of any bone-related events you experience. The total length of your participation would depend on how your treatment progresses, but the study continues until a certain number of bone events are observed across all patients.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as receiving Denosumab at a reduced frequency, which might lead to fewer clinic visits and potentially fewer side effects over time. You will also be closely monitored by a medical team. However, there are potential risks, including side effects from Denosumab such as low calcium levels or, rarely, jawbone problems. There's also a chance that giving the medicine less often might not be as effective in preventing bone problems, which is exactly what the study is trying to find out. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (50)

Landeskrankenhaus Feldkirch
Verified postcode
Feldkirch, Austria
Klinikum Wels-Grieskrichen GmbH
Verified postcode
Wels, Austria
Uniklinik Düsseldorf, Urologische Klinik
Verified postcode
Düsseldorf, Germany
Universitätsklinikum Düsseldorf, Frauenheilkunde/Geburtshilfe
Verified postcode
Düsseldorf, Germany
Universitätsmedizin Göttingen
Verified postcode
Göttingen, Germany
Universitätsklinikum Schleswig-Holstein
Verified postcode
Lübeck, Germany
Universitäts-Frauenklinik Ulm
Verified postcode
Ulm, Germany
Hirslanden Klinik Aarau
Verified postcode
Aarau, Switzerland
Kantonspital Aarau
Verified postcode
Aarau, Switzerland
Kantonsspital Baden
Verified postcode
Baden, Switzerland
Universitaetsspital Basel
Verified postcode
Basel, Switzerland
Brustzentrum Basel - Praxis für ambulante Tumortherapie
Verified postcode
Basel, Switzerland

Common questions

What is Denosumab and why is it used?

Denosumab is a medicine that helps strengthen bones and reduce bone problems like fractures in people whose cancer has spread to their bones. It works by slowing down the process that breaks down bone.

What's the main question this study wants to answer?

The study wants to see if giving Denosumab every 12 weeks is just as good at preventing bone problems as giving it every 4 weeks. This could mean fewer injections and potentially fewer side effects for patients.

Will I know which treatment group I'm in?

Yes, this is an 'open-label' study, which means both you and your doctor will know whether you are receiving Denosumab every 4 weeks or every 12 weeks.

What exactly do they mean by 'bone problems'?

In this study, 'bone problems' refers to things like needing radiation treatment or surgery for your bones, having a bone break due to cancer, or pressure on your spinal cord because of cancer in your bones.

How long will I be involved in the study?

Your involvement will continue as long as your treatment progresses and the study is gathering information about bone events. The total duration will vary for each person.