Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia® Sourced from the European Union in Postmenopausal Women with Osteoporosis

This important study is looking at a new medicine, MAB-22, and comparing it to a widely used treatment called Prolia. Both are for women who have gone through menopause and have osteoporosis – a condition that makes bones weak and more likely to break. The main goal is to see if MAB-22 is just as good as Prolia at strengthening bones, specifically in the spine. Researchers will also be checking how the body reacts to MAB-22, how safe it is, and if there are any unwanted side effects. This is a "Phase III" study, which means it's a large, final stage of testing before a new medicine might become available. It's a crucial step to make sure MAB-22 is both effective and safe for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Xentria Inc.

Enrolment target

440

Start

25 Sep 2024

Osteoporosis

What is this study about?

This study is a research project focusing on a condition called osteoporosis in women who have gone through menopause. Osteoporosis makes bones fragile and more likely to break. The goal of the study is to compare a new medicine, called MAB-22, with a well-known existing treatment, Prolia. Both of these medicines aim to help strengthen bones.

Researchers want to see if MAB-22 works as well as Prolia in terms of strengthening bone, especially in the spine. They will also be closely watching to see how the body handles MAB-22 – this includes how it moves through the body, how it affects bone health at a chemical level, and crucially, if it's safe and doesn't cause too many unwanted reactions. Because medicines can sometimes cause the body to make anti-drug antibodies, which might reduce how well the medicine works, the study will also be checking for these.

This is a 'Phase III' study, which is a major step in developing new medicines. It means researchers are trying to confirm if MAB-22 is a successful and safe treatment option compared to what's currently available. The results of this study will help doctors and patients understand if MAB-22 could be another good choice for managing osteoporosis.

Key takeaways

This study compares a new osteoporosis medicine (MAB-22) with a current one (Prolia).
It's for women who have gone through menopause and have osteoporosis.
The main goal is to see how well MAB-22 strengthens bones in the spine.
Researchers will also check for safety, side effects, and how the body uses the medicine.
Taking part involves regular clinic visits, blood tests, and bone density scans.
You won't know if you're getting the new medicine or the standard one (double-blind study).

Who may be eligible?

This study is specifically looking for women who have already gone through menopause and have been diagnosed with osteoporosis. You'll need to be at least 18 years old to take part.

There might be other health conditions or medicines that would prevent you from joining, as the researchers need to make sure everyone in the study meets very specific health criteria. This helps them get clear results about the new medicine. Your doctor will be able to check if you meet all the requirements.

Essentially, if you're a postmenopausal woman with osteoporosis, you could potentially be eligible for this study.

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.

Are you a woman who has gone through menopause?
Have you been diagnosed with osteoporosis?
Are you 18 years old or older?
Are you able to attend regular clinic appointments for about 18 months?
Do you have any other serious health conditions or are you taking other specific medications that might exclude you? (Speak to your doctor)

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be randomly assigned to receive either the new medicine, MAB-22, or the existing medicine, Prolia. Neither you nor your study doctor would know which one you are receiving – this is called 'double-blind' and helps ensure the results are unbiased. Both medicines are given as an injection.

You would have regular visits to the clinic over a period of about 18 months (78 weeks). During these visits, the study team would take measurements of your bone density, especially in your spine and hip, to see how the treatment is working. They would also take blood and urine samples to check your general health, how the medicine is affecting your body, and if there are any signs of your body reacting to the medicine.

Throughout the study, vital signs like your blood pressure and heart rate would be checked, and you would have physical examinations and ECGs (heart tracings). You would also be asked about any side effects or changes in your health. The study team would continue to monitor your safety until the end of the study period.

Potential risks and benefits

Taking part in this study could offer you access to a new potential treatment for osteoporosis that might be beneficial. You'll receive regular health checks and monitoring from a dedicated medical team. However, as with any medicine, there's a chance of side effects, which might be mild or more serious, and the new medicine might not work for everyone. The study team will closely monitor you for any potential issues. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Czechia
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Unverified
Bulgaria
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Unverified
Poland

Common questions

What is osteoporosis?

Osteoporosis is a condition that makes your bones weak and brittle, meaning they can break more easily, even from minor bumps or falls.

What does a 'Phase III' study mean?

Phase III means it's a large study, usually one of the final steps, to confirm if a new medicine is safe and works better than or as well as existing treatments, before it can be made available to everyone.

Will I know if I'm getting the new medicine or the existing one?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is complete. This helps keep the results unbiased.

How long will I be in the study?

The study involves regular check-ups over approximately 18 months (78 weeks) to monitor your progress and safety.

What if I experience side effects?

The study team will closely monitor you for any side effects, and it's important to report any changes in your health to them immediately.