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A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture

NCT05060406 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2021-09-29

No results posted yet for this study

Summary

A multicenter, randomized, double-blind, placebo-controlled phase III clinical study will be conducted to evaluate the efficacy and safety of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for fracture, as well as an exploratory population pharmacokinetic analysis of LY06006.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

LY06006

60 mg/1 ml, once every 6 months administered subcutaneously, two injections in total

Sponsors & Collaborators

  • Shang Dong Boan Biotechnology Co., Ltd (Co-sponsor)

    collaborator UNKNOWN

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhenlin Zhang, doctor · Shanghai 6th People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2021-09-30
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05060406 on ClinicalTrials.gov