Effect of Romosozumab vs. Denosumab on Coronary Atherosclerotic Damage in Postmenopausal Osteoporotic Women: A Phase IV, Low-Risk, Pharmacological Intervention Study. ATRIO Study.
This research, called the ATRIO study, is for postmenopausal women who have osteoporosis. We're investigating how two widely used osteoporosis treatments, Evenity and Prolia, might affect the health of your heart's blood vessels. Specifically, the study will compare how these medicines influence the build-up of fatty deposits (atherosclerosis) in the coronary arteries over a year. Using special CT scans of the heart, we aim to understand if one treatment is different from the other in this regard. This is an important step to ensure that while we treat bone health, we also understand the broader effects on women's cardiovascular health.
At a glance
What is this study about?
The ATRIO study is looking into an important question: how do common treatments for weak bones (osteoporosis) in women after menopause affect their heart and blood vessels? Many women take medicines like Evenity (Romosozumab) and Prolia (Denosumab) to strengthen their bones and prevent fractures. This study wants to see if these medicines have any impact on the health of the arteries that supply blood to the heart.
Specifically, researchers will be looking for changes in something called 'coronary atherosclerotic damage.' This is a medical way of saying a build-up of fatty materials and hardening in the arteries around the heart. This build-up can sometimes lead to heart problems. By comparing women taking Evenity with those taking Prolia, the study hopes to find out if one treatment shows different effects on these heart arteries after a year.
To do this, participants will have special scans of their heart called CT scans. These scans will help the doctors measure any changes in the heart's arteries. They will also look at certain markers in the blood that are linked to heart health. This research is important because it helps doctors understand the full picture of how these osteoporosis medicines affect a woman's health, not just their bones but also their heart.
Key takeaways
- Compares two common osteoporosis medicines: Evenity and Prolia.
- Focuses on heart artery health in postmenopausal women.
- Uses heart CT scans and blood tests to measure changes.
- Study duration is 12 months.
- Aims to improve understanding of long-term treatment effects.
Who may be eligible?
This study is specifically looking for women who have gone through menopause and have been diagnosed with osteoporosis. You'll need to be at least 18 years old to take part. There isn't an upper age limit mentioned, so older women are welcome to consider participating.
The main focus is on comparing the effects of two existing and commonly used medications for osteoporosis on heart health. If you meet these general criteria, the research team will check other specific health details to make sure the study is a good fit for you and that taking part would be safe and appropriate.
- Are you a woman?
- Have you gone through menopause?
- Do you have a diagnosis of osteoporosis?
- Are you aged 18 or over?
- Are you willing to potentially receive either Evenity or Prolia treatment?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive either Evenity or Prolia, depending on which group you are assigned to (this is usually decided randomly, like flipping a coin). Both medicines are given as an injection, either with a pre-filled pen or syringe. You might have several visits over 12 months to receive your medication and for check-ups.
Throughout the study, you would have CT scans of your heart at the beginning and again after 12 months. These scans help doctors see if there are any changes in your heart's blood vessels. You would also have blood tests at the start and potentially at other points to check various health markers. The total duration of the active treatment and observation period for this study is 12 months.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What is osteoporosis?
Osteoporosis is a condition that causes bones to become weak and brittle, making them more likely to break. It's common in women after menopause.
What are Evenity and Prolia?
Evenity (romosozumab) and Prolia (denosumab) are both approved medicines used to treat osteoporosis and help strengthen bones.
What does a 'coronary CT score' mean?
It's a measurement taken from a special X-ray scan of your heart (CT scan) that helps doctors see if there is any build-up or hardening in the blood vessels around your heart.
Will I know which medicine I'm getting?
Often in studies like this, participants are assigned to one treatment or another by chance, without knowing which one they are receiving, to make the comparison fair. The study team will explain this fully.
Why is this study important for women?
This study is important because it will help doctors understand more about how common osteoporosis treatments might also affect women's heart health, providing a more complete picture of their overall well-being.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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