← Back to Search

Monoclonal Antibodies

Denosumab 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

Must not have

Participant requires ongoing use of any osteoporosis treatment

Participant has a history of bone disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-12 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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

Select...

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

Select...

I am between 60 and 90 years old.

Select...

My weight is between 50 kg and 90 kg.

Select...

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

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently on treatment for osteoporosis.

Select...

I have a history of bone disease.

Select...

I currently have a fracture that is healing.

Select...

I have had both of my hips replaced.

Select...

My thyroid condition is not currently under control.

Select...

I have a condition affecting my bones or joints.

Select...

I have a history of hepatitis B, C, or HIV.

Select...

I have had a hip fracture.

Select...

I cannot take denosumab or supplements for calcium or vitamin D due to health reasons.

Select...

I have severe kidney problems.

Select...

My liver isn't working properly.

Select...

I have had or currently have an unusual fracture in my thigh bone.

Select...

I have had cancer in the last 5 years.

Select...

I have had or currently have bone damage in my ear canal.

Select...

I have a long-term inflammatory disease.

Select...

I have a history of abnormal parathyroid gland activity.

Select...

I have a known history of liver cirrhosis.

Select...

I have not had major surgery in the last 8 weeks or planned soon.

Select...

I have a history of heart disease or abnormal heart tests.

Select...

I have had severe or more than two moderate spine fractures.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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