Denosumab for Osteoporosis

Recruiting in Palo Alto (17 mi)

+38 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Luye Pharma Group Ltd.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

this comparative clinical study is designed to demonstrate that LY06006 and EU-Prolia have no clinically meaningful differences in clinical efficacy, pharmacodynamic (PD), safety, PK, and immunogenicity in postmenopausal women with osteoporosis.

Research Team

Joe Tai

Principal Investigator

Luye Pharma Group Ltd.

Eligibility Criteria

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.

Inclusion Criteria

Serum FSH test can be done at the Screening Visit in case of uncertainty

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

My weight is between 50 kg and 90 kg.

See 5 more

Exclusion Criteria

I am currently on treatment for osteoporosis.

I have a history of bone disease.

I currently have a fracture that is healing.

See 32 more

Treatment Details

Interventions

Denosumab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.

Denosumab is already approved in Canada, Japan for the following indications:

Approved in Canada as Prolia for:

Treatment of osteoporosis in postmenopausal women at high risk for fracture
Treatment to increase bone mass in men with osteoporosis at high risk for fracture