Study on the Effectiveness and Safety of LY06006 and Denosumab for Postmenopausal Women with Osteoporosis

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What is this study about?

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.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, postmenopausal status, and bone density measurements.

Participants must be between 55 and 90 years old and have a body weight between 50 kg and 90 kg.

2 initial assessment

An initial assessment is conducted, including a physical and dental examination, vital signs check, and clinical laboratory tests.

A 12-lead ECG is performed to assess heart function.

3 medication administration

Participants receive either LY06006 or EU-Prolia, both containing the active substance denosumab, administered as a subcutaneous injection.

The medication is given as a 60 mg solution for injection in a pre-filled syringe.

4 follow-up assessments

Follow-up assessments occur at various intervals: Months 0.5, 1, 2, 3, 6, 9, and 12.

These assessments include bone density measurements, blood tests for bone markers, and monitoring for any adverse effects.

5 monitoring and evaluation

Participants are monitored for any injection site reactions and changes in serum drug concentrations.

The presence of antibodies against the medication is checked at baseline and during follow-up visits.

6 final evaluation

At the end of the study, a comprehensive evaluation is conducted to assess the efficacy and safety of the treatment.

The study aims to demonstrate equivalent efficacy between LY06006 and EU-Prolia in improving bone density in postmenopausal women with osteoporosis.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Krakowskie Centrum Medyczne Sp. z o.o.	Cracow	Poland
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Synexus Czech s.r.o.	Prague	Czechia
Pratia Brno s.r.o.	Brno-Stred	Czechia
Diagnostic Consultative Centre Ascendent OOD	Sofia	Bulgaria
Synexus Polska Sp. z o.o.	Poznan	Poland
Pratia S.A.	Skorzewo	Poland
Mdzibjt Cnkpfp Puxsrv Cfdgai Edxf	Lovech	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	27.04.2023
Czechia	Not recruiting	27.04.2023
Poland	Not recruiting	27.04.2023

Trial locations

Investigated drugs:

Denosumab

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.

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 ID:

2024-513591-18-00

Protocol code:

LY06006/MRCT-301

NCT ID:

NCT05853354

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of LY06006 and Denosumab for Postmenopausal Women with Osteoporosis

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