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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive one of two different medications through a subcutaneous injection, which means the medicine is injected into the fatty tissue just under the skin.
One group receives romosozumab (evenity) at a dose of 210 mg.
The other group receives denosumab (prolia) at a dose of 60 mg.
Step 2
Treatment period
The medication administration continues for a duration of 12 months.
During this time, the impact of the therapy on coronary atherosclerotic damage, which is the buildup of plaque in the heart arteries, is monitored.
Measurements are taken to track changes in coronary CT scores, a method used to evaluate the condition of the heart arteries through imaging.
Step 3
Follow-up and measurement
Changes in specific heart artery scores, known as the segment involvement score and the segment stenosis score, are measured to evaluate the progression of the condition.
biomarkers, which are measurable substances in the body, are evaluated to see how they relate to the changes in the heart artery scores. these include sclerostin, lipoprotein-associated phospholipase a2, myeloid-related protein 8 and 14, and monocyte chemoattractant protein 1 (mcp-1).

Who can join the trial?

6 criteria

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 trial?

17 criteria

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.

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Verified sites

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Verified
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
Milan, Italy
Responsive
Ospedale Galeazzi S.p.A.
Milan, Italy

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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.

What is already known about the treatment

ROMOSOZUMAB
This medication is an injectable solution administered under the skin to treat bone loss. It is currently used in medicine to help increase bone density in people with severe osteoporosis. The drug works by targeting and blocking a specific protein in the body that regulates bone formation and breakdown, effectively helping to build new bone while slowing its loss. It belongs to a class of drugs known as sclerostin inhibitors.
DENOSUMAB
This medication is an injectable solution administered under the skin to treat bone-related conditions. It is an established treatment used to increase bone mass and reduce the risk of fractures in patients with osteoporosis. At a molecular level, it works by blocking a protein called RANKL, which prevents the cells that break down bone from becoming too active. It is classified as a bone resorption inhibitor.

Investigated diseases

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.