Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A randomized, double-blind, parallel-group, active-controlled comparative study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of LY06006 compared with EU-Prolia in postmenopausal women with osteoporosis

This research study is for women who have gone through menopause and have osteoporosis. Osteoporosis is a condition that makes bones weak and more likely to break. The study wants to find out if a new medicine, LY06006, is just as good, or possibly better, than a current medicine called Prolia for making bones stronger. Both medicines are given as injections. Researchers will carefully check how well the new medicine works, if it's safe, and how it behaves in the body. They will also look at any side effects. This is a large study (Phase III) to confirm its effectiveness and safety before it can be widely used by patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Shandong Boan Biotechnology Co. Ltd., Shandong Boan Biotechnology Co. Ltd.

Enrolment target

460

Start

14 Nov 2024

Postmenopausal osteoporosis

What is this study about?

This study is designed for women who have gone through menopause and have osteoporosis. Osteoporosis is a common condition that causes bones to become thin and brittle, meaning they can break more easily. The main goal of this research is to see if a new medicine, called LY06006, can help strengthen bones just as effectively and safely as a medicine that is already available, called Prolia. Both medicines are given as an injection.

Researchers will be looking at several things. They will measure changes in bone strength, particularly in areas like the spine and hip, to see if the medicines are working. They will also carefully monitor for any side effects and check how the body reacts to the medicines. This comparison is important because it helps doctors understand which treatments are best for patients with osteoporosis.

This kind of study, known as a Phase III trial, is a crucial step in developing new medicines. It involves a larger number of people and provides a lot of important information about a medicine's benefits and risks before it can be approved for general use. By taking part, volunteers help us learn more about potential new ways to treat osteoporosis.

Key takeaways

This study is for postmenopausal women with osteoporosis.
It compares a new medicine (LY06006) to an existing one (Prolia) for bone strengthening.
Both medicines are given by injection.
Participation involves regular clinic visits, physical exams, blood tests, and bone scans.
It's a long-term study to gather full information on safety and effectiveness.
You can withdraw from the study at any time.

Who may be eligible?

This study is specifically looking for women who have already gone through menopause – meaning their menstrual periods have stopped for a while. You also need to have been diagnosed with osteoporosis, which means your bones are weaker than they should be, making them more prone to breaks.

To be considered for this study, you must be female and at least 18 years old. There isn't an upper age limit mentioned, so older women are also welcome to inquire.

Beyond these basic requirements, there will be other health checks and medical history questions to ensure the study is safe and appropriate for you. For example, the study team will need to make sure you don't have any other conditions that might interfere with the results or put your health at risk during the trial.

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?
Have you gone through menopause?
Have you been diagnosed with osteoporosis?
Are you at least 18 years old?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the new medicine (LY06006) or the existing medicine (Prolia) as an injection. This will be decided randomly, like flipping a coin, and neither you nor your study doctor will know which one you are getting. This is to make the comparison fair.

You will have several appointments at the study clinic over a period of time. During these visits, doctors and nurses will check your overall health, including taking your blood pressure and checking your teeth. You’ll have blood and urine tests, and an ECG (a test that checks your heart). They will also look carefully at your injection sites and ask about any side effects you might experience. Bone scans will be done to see how your bone strength is changing. The study will continue for a substantial period, with follow-up appointments extending beyond a year to fully understand the long-term effects of the medicines. The full duration of your involvement will be clearly explained to you.

Potential risks and benefits

Participating in a clinical trial may offer certain benefits, such as receiving close medical care and access to a new medicine that isn't widely available yet, which might help improve your bone health. However, like all medicines, both the study medicine and the comparison medicine can have side effects, which could range from mild to serious. There's also no guarantee that the study medicine will be effective for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care. All potential risks and benefits will be fully explained to you before you decide whether to take part.

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 more likely to break, even from a minor fall or bump.

What is menopause?

Menopause is when a woman's menstrual periods stop permanently, usually around the age of 45-55. This change can sometimes lead to weaker bones.

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

No, this is a 'blinded' study, meaning neither you nor your doctor will know which treatment you are receiving until the study concludes. This helps ensure fair results.

How will the medicine be given?

Both the new medicine (LY06006) and the existing medicine (Prolia) are given as an injection.

Can I stop participating in the study if I want to?

Yes, absolutely. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.