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NCT05853354 · ClinicalTrials.gov registry record · Phase 3
Comparative Efficacy, Safety, PK, and Immunogenicity Study
A Phase 3 study of Osteoporosis, Postmenopausal, sponsored by Luye Pharma Group.
- Active
- Registry status
- Phase 3
- Development phase
- 392
- Enrollment target
- 20
- Study locations
NCT05853354 is a Phase 3 study of Osteoporosis, Postmenopausal that is active but no longer recruiting, run by Luye Pharma Group. The registered enrollment target is 392 participants, below the 3,220-participant average among 10 other Osteoporosis, Postmenopausal trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT05853354, a Phase 3 study of Osteoporosis, Postmenopausal, is active but no longer recruiting, sponsored by Luye Pharma Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 392 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Denosumab
Study Locations (20)
Other
- MHAT Dr. Atanas Dafovski AD - Kardzhali
- Medical Centre Leo Clinic EOOD - Plovdiv
- Diagnostic-consultative center Ascendent EOOD - Sofia
- Medical Center Leo Clinic EOOD - Varna
- CCR Brno s.r.o. - Brno
- Synexus Prague - Prague
Hukuoka
- Asakawa Orthopedic Clinic - Chikugo
- Obase Hospital - Orthopedics - Miyako-gun
- Himeno Hospital - Yame-gun
Tôkyô
- Med Teda Ooimachi Orthopaedic - Shinagawa-ku
- Koenji Orthopedic Surgery - Shinagawa-ku
California
- Clinical Trials Management Services, LLC - Thousand Oaks
Florida
- Indago Research and Health Center, Inc. - Hialeah
Texas
- Valley Institute of Research - Fort Worth
Gihu
- Gifu Prefectural General Med C. - Gifu
Nagano
- Marunouchi Hospital - Matsumoto-shi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 392 participants |
| Start Date | 2023-04-05 |
| Est. Completion | 2025-12-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05853354
The ClinicalTrials.gov registry entry for NCT05853354 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 392 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,220-participant average among 10 other Osteoporosis, Postmenopausal trials with a reported enrollment target (88% lower). The listed sponsor is Luye Pharma Group, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Osteoporosis, Postmenopausal appearing as the primary indexed condition, and to 1 intervention - of which Denosumab is the first listed.
NCT05853354 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Hukuoka, Tôkyô.
Frequently Asked Questions
What is clinical trial NCT05853354 about?
NCT05853354 is a clinical study titled "Comparative Efficacy, Safety, PK, and Immunogenicity Study". 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.
What is the current status of trial NCT05853354?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 392 participants. The study started on 2023-04-05. Estimated completion is 2025-12-30.
What conditions does trial NCT05853354 study?
This clinical trial studies the following conditions: Osteoporosis, Postmenopausal.
What interventions are being tested in trial NCT05853354?
The interventions under investigation include: Denosumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05853354?
This trial is sponsored by Luye Pharma Group, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05853354 being conducted?
This trial has 20 study locations across California, Florida, Texas, Gihu, Hukuoka. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.