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Monoclonal Antibodies

LY06006 for Osteoporosis

Phase 3

Waitlist Available

Research Sponsored by Luye Pharma Group Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is an ambulatory postmenopausal woman

Participant is ≥ 60 to ≤ 90 years of age inclusive, at the time of signing the informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-12 months

Awards & highlights

Study Summary

"This trial aims to show that two different medications, LY06006 and EU-Prolia, are equally effective and safe for treating osteoporosis in postmenopausal women."

Who is the study for?

This trial is for ambulatory postmenopausal women aged 60-90 with osteoporosis, having a T-score of ≤ -2.5 and ≥ -4.0 at the lumbar spine. Participants must weigh between 50 kg and 90 kg, have had no menstrual period for at least 12 months or undergone bilateral oophorectomy, and be able to give informed consent.Check my eligibility

What is being tested?

The study tests whether LY06006 has similar effects as EU-Prolia in treating osteoporosis in postmenopausal women by comparing their efficacy, safety, pharmacokinetics (PK), and immune response.See study design

What are the potential side effects?

Denosumab may cause side effects such as low calcium levels in the blood, skin infections around the injection site, back pain, joint pain, muscle pain or bladder infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman who has gone through menopause and can walk.

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I am between 60 and 90 years old.

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My weight is between 50 kg and 90 kg.

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My bone density scan shows I have osteoporosis with a specific severity.

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I can have bone density tests on my lower spine and one hip.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

EU Marketing Authorization only: To demonstrate similar PD between LY06006 and EU-Prolia, in terms of the bone resorption marker sCTX in female participants with postmenopausal osteoporosis

To demonstrate equivalent efficacy between LY06006 and EU-Prolia, in terms of BMD in female participants with postmenopausal osteoporosis;

Secondary outcome measures

To provide additional comparative efficacy data of LY06006 with EU-Prolia in female participants with postmenopausal osteoporosis

Side effects data

From 2022 Phase 4 trial • 37 Patients • NCT04026256

44%

joint pain

22%

nausea

22%

propagation of fracture at biopsy site

11%

dizziness

11%

rhinorrhea

100%

80%

60%

40%

20%

Study treatment Arm

Denosumab Only

Teriparatide Only

Denosumab and Teriparatide

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LY06006Experimental Treatment1 Intervention

to be administered 2 doses to the patients at the main treatment period and 1 dose at the transition period.

Group II: EU ProliaActive Control1 Intervention

to be administered 2 doses to the patients at the main treatment period and 1 dose at the transition period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Denosumab

2013

Completed Phase 4

~12010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Luye Pharma Group Ltd.Lead Sponsor

59 Previous Clinical Trials

8,219 Total Patients Enrolled

1 Trials studying Osteoporosis

448 Patients Enrolled for Osteoporosis

Joe TaiStudy ChairLuye Pharma Group Ltd.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which specific criteria must be met for individuals to be eligible for participation in this medical investigation?

"Individuals aged between 60 and 90 years diagnosed with osteoporosis are encouraged to participate in this research study. A total of 392 participants will be enrolled in the trial."

Answered by AI

Are new participants currently being accepted for enrollment in this ongoing medical study?

"As per clinicaltrials.gov, this investigation is presently not in the recruitment phase. Its initial posting date was 4/5/2023 with the latest update noted on 4/24/2024. While inactive at present, there are currently 121 alternative studies actively seeking participants."

Answered by AI

Is this trial enrolling individuals aged 80 and above?

"Patients aged between 60 and 90 are sought for enrollment in this particular research study. Notably, there are a dozen trials designated for participants under 18 years old and an additional 106 studies targeting individuals over the age of 65."

Answered by AI

In how many healthcare facilities is this clinical study currently being conducted?

"This clinical study is being conducted at Asakawa Orthopedic Clinic in Chikugo, Saitama, Pratia MCM Krakow in Krakow, Wielkopolskie, and Nemoto Geka SeikeiGeka in Fujimi, California alongside an additional 39 sites."

Answered by AI

Has the medication LY06006 received approval from the Food and Drug Administration (FDA)?

"Our team at Power has evaluated the safety of LY06006 to be a 3 on our scale, based on the Phase 3 trial status. This indicates that there is substantial evidence supporting both its efficacy and safety profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparative Efficacy, Safety, PK, and Immunogenicity Study

2023. "Comparative Efficacy, Safety, PK, and Immunogenicity Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05853354.

All > Osteoporosis