Futuremeds Sp. z o.o.
Wroclaw, Poland
Not recruiting
Study on the Effectiveness and Safety of LY06006 and Denosumab for Postmenopausal Women with Osteoporosis
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of two treatments for postmenopausal osteoporosis, a condition where bones become weak and are more likely to break in women who have gone through menopause. The treatments being compared are called LY06006 and EU-Prolia. Both treatments contain the active substance denosumab, which is a type of protein used to help strengthen bones.
The purpose of the study is to compare the effectiveness and safety of LY06006 and EU-Prolia in women with postmenopausal osteoporosis. Participants in the study will receive either LY06006 or EU-Prolia through an injection under the skin. The study will last for about 18 months, during which participants will have regular check-ups to monitor their bone health and overall well-being.
Throughout the study, various health assessments will be conducted, including blood tests and bone density scans, to ensure the treatments are working as intended and to check for any side effects. The study aims to determine if LY06006 is as effective and safe as EU-Prolia in treating postmenopausal osteoporosis.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- The participant must be between 55 and 90 years old. In the Czech Republic, the age limit is up to 75 years.
- The participant must be a postmenopausal woman, meaning she hasn't had a menstrual period for at least 12 months for reasons not related to other health issues. If there's uncertainty, a blood test called **serum FSH** can be done to confirm menopause. In Bulgaria, this test is required.
- The participant must have been diagnosed with **osteoporosis**, a condition where bones become weak. This is confirmed by a bone density test showing a **T-score** between -2.5 and -4.0 at the lower spine.
- The participant must have at least two lower spine bones and one hip that can be measured for bone density during the screening.
- The participant's body weight must be between 50 kg and 90 kg at the time of screening.
- The participant must be able to read, understand, and agree to sign a consent form, which includes following the study's rules and requirements.
Who cannot join the trial?
4 criteria
- Patients who are not female cannot participate.
- Patients who are not in the age range specified for the study cannot participate. The study is for certain age groups only.
- Patients who do not have **postmenopausal osteoporosis** cannot participate. This condition refers to a weakening of the bones that occurs after menopause.
- Patients who are part of a vulnerable population cannot participate. This means groups of people who might need special protection or care.
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Verified sites
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Responsive Responsive Krakowskie Centrum Medyczne Sp. z o.o.
Cracow, PolandVerified Synexus Polska Sp. z o.o.
Poznan, Poland
Trial locations
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Investigated drugs
LY06006
is a medication being studied for its effectiveness in treating postmenopausal osteoporosis. It is designed to help increase bone mineral density (BMD) in women who have gone through menopause and are experiencing bone loss. The study aims to show that LY06006 works as well as another treatment in improving bone health.
EU-Prolia
is an existing medication used to treat osteoporosis in postmenopausal women. It helps to strengthen bones and reduce the risk of fractures by increasing bone mineral density. In this study, EU-Prolia is used as a comparison to evaluate the effectiveness of LY06006.
What is already known about the treatment
LY06006
This medication is administered via injection and is currently being studied in clinical trials for its effectiveness in treating postmenopausal osteoporosis. It is designed to be equivalent in efficacy to an existing medication, EU-Prolia, and is being evaluated for its impact on bone mineral density. LY06006 works by targeting specific pathways involved in bone resorption, helping to maintain bone strength. It falls under the pharmacological classification of bone density conservation agents.
EU-Prolia
This medication is also administered through injection and is well-established in the treatment of postmenopausal osteoporosis. It is used to increase bone mineral density and reduce the risk of fractures. EU-Prolia functions by inhibiting the activity of cells that break down bone tissue, thereby preserving bone mass. It is classified as a bone density conservation agent and is widely recognized in medical literature for its role in osteoporosis management.
Investigated diseases
Postmenopausal Osteoporosis – This condition occurs in women after menopause, characterized by weakened bones and an increased risk of fractures. It results from a decrease in estrogen levels, which affects bone density and strength. Over time, bones become more porous and fragile, making them more susceptible to breaks even from minor falls or injuries. The disease progresses gradually, often without symptoms until a fracture occurs. Common fracture sites include the hip, spine, and wrist. Regular monitoring of bone mineral density can help track the progression of this condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513591-18-00Protocol codeLY06006/MRCT-301Estimated enrolment530 patientsSponsorShandong Boan Biotechnology Co. Ltd.
sourced from the EU Clinical Trials Register and site verification
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