Comparing the effect of romosozumab and denosumab on coronary artery damage in women with postmenopausal osteoporosis

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What is this study about?

This study focuses on women who have experienced menopause and are living with Osteoporosis, a condition where bones become weak and fragile. The research specifically examines how certain treatments might affect Coronary Atherosclerotic Damage, which refers to the buildup of plaque or hard materials in the arteries that supply blood to the heart. The purpose of the study is to compare the effects of two different medications on this buildup of plaque in the heart arteries.

The two medications being compared are romosozumab and denosumab. Participants will receive one of these treatments through a subcutaneous injection, which means the medicine is delivered into the fatty layer of tissue just under the skin. One group will receive romosozumab, while the other group will receive denosumab for comparison.

During the study, the condition of the heart arteries will be monitored. This is done using a computed tomography scan, a type of imaging that uses X-rays to create detailed pictures of the inside of the body. The researchers will look at changes in the heart’s arterial health over a period of 12 months of therapy to see how the two medications compare.

Who Can Join the Study?

You must be a female patient.
You must require treatment with either Romosozumab or Denosumab, which are specific types of medications, based on the official medical guidelines provided by the Italian Medicines Agency (AIFA).
You must be receiving secondary prophylaxis, which means you are taking medication to prevent a medical condition or a complication from happening again.
You must have postmenopausal osteoporosis, a condition where bones become weak and brittle after a woman has gone through menopause (the time in life when a woman no longer has monthly periods).
To confirm you are postmenopausal, you must have not had a period for at least 12 months without another medical reason. Doctors may also check your follicle-stimulating hormone (a hormone that helps control the menstrual cycle) to confirm this status.
You must sign the Informed Consent Form, which is a document you read and sign to show you understand the study and agree to participate.

Who Cannot Join the Study?

Having diabetes mellitus, which is a condition that affects how your body turns food into energy.
Having a history of any bone disease other than osteoporosis, such as Paget’s disease, which is a condition that causes bones to become weak or misshapen.
Having active neoplasms, which means having active cancer, including those who have been in remission (a period where cancer signs and symptoms have disappeared) for more than 5 years.
A history of acute myocardial infarction, commonly known as a heart attack, or a stroke, regardless of when they happened.
Drinking more than 2 units of alcohol per day.
Being an active smoker.
Having participated in another clinical study involving a new medicine within 30 days before this study starts or within a specific timeframe based on how long the previous medicine stays in your body.
Having hypocalcemia, which is a condition where the level of calcium (a mineral important for bones and muscles) in your blood is too low.
Having a previous allergic reaction to iodinated contrast media (a special dye used during certain medical scans) or an allergy to the medicines or ingredients used in this study.
Currently taking steroids, immunosuppressive therapy (medicines that lower your immune system), or other drugs known to affect bone metabolism (the process by which your body breaks down and builds bone).
For women aged 69 or younger: having a cardiovascular risk of 20% or higher over the next 10 years, which is the chance of having a heart-related problem.
For women aged 70 or older: having a specific heart risk score higher than 15% over the next 10 years.
Having uncontrolled hypercholesterolemia, which means having high levels of cholesterol (a fatty substance in the blood) that is not managed well by medication or lifestyle.
Having uncontrolled hypertension, which means having high blood pressure that is not properly managed by medication.
Having active endocrinopathies, which are disorders of the glands that produce hormones, except for subclinical hypothyroidism (a mild condition where the thyroid gland is slightly underactive).
Having chronic renal failure, which is long-term kidney damage, specifically in stages IIIb, IV, or V.
Having chronic liver disease, which is long-term damage to the liver, categorized as Child B or C.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto	Milan	Italy
Ospedale Galeazzi S.p.A.	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.12.2025

Trial locations

Investigated drugs:

Evenity is a medication administered through an injection under the skin. It is being tested in this study to see how it affects the buildup of plaque in the heart arteries in women with osteoporosis after menopause.

Prolia is a medication administered through an injection under the skin. In this study, it is used as a comparison treatment to evaluate how it affects coronary artery damage compared to the test medication.

Investigated diseases:

Osteoporosis postmenopausal

Coronary atherosclerotic status in women with postmenopausal osteoporosis – This condition involves the buildup of fatty deposits and plaque within the arteries that supply blood to the heart. In women who have gone through menopause, this process may occur alongside a decrease in bone density. The buildup can cause the arteries to narrow or harden over time. As the plaque accumulates, it may restrict the flow of oxygen-rich blood to the heart muscle. This progression is often characterized by changes in the structure of the vessel walls.

Trial ID:

2025-522592-29-00

Protocol code:

ATRIO (L4204)

Trial Phase:

Therapeutic confirmatory (Phase III)

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Comparing the effect of romosozumab and denosumab on coronary artery damage in women with postmenopausal osteoporosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?