Comparative Efficacy, Safety, PK, and Immunogenicity Study

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

392

Participants

Timeline

Start Date

April 5, 2023

Primary Completion Date

July 30, 2025

Study Completion Date

December 30, 2025

Conditions
Osteoporosis, Postmenopausal
Interventions
BIOLOGICAL

Denosumab

Sterile, preservative-free, solution of denosumab packed in 1-mL pre-filled glass syringes for subcutaneous administration.Each syringe contains 60 mg denosumab (60 mg/mL solution) and is intended for single administration once every 6 months.

Trial Locations (39)

1202

Diagnostic-consultative center Ascendent EOOD, Sofia

4003

Medical Centre Leo Clinic EOOD, Plovdiv

6600

MHAT Dr. Atanas Dafovski AD, Kardzhali

9000

Medical Center Leo Clinic EOOD, Varna

12000

Synexus Prague, Prague

33012

Indago Research and Health Center, Inc., Hialeah

60200

CCR Brno s.r.o., Brno

76164

Valley Institute of Research, Fort Worth

91360

Clinical Trials Management Services, LLC, Thousand Oaks

500-8717

Gifu Prefectural General Med C., Gifu

833-0031

Asakawa Orthopedic Clinic, Chikugo

800-0344

Obase Hospital - Orthopedics, Miyako-gun

834-0115

Himeno Hospital, Yame-gun

390-8601

Marunouchi Hospital, Matsumoto-shi

354-0021

Nemoto Geka SeikeiGeka, Fujimi

437-0061

Kobayakawa Orthopedic Rheumatologic, Fukuroi

140-0014

Med Teda Ooimachi Orthopaedic, Shinagawa-ku

166-0003

Koenji Orthopedic Surgery, Shinagawa-ku

750-8520

Shimonoseki City Hospital, Shimonoseki

874-0937

Nakamura Hospital, Beppu

60-185

Centrum Medyczne Pratia Poznan, Skórzewo

60-535

Centrum Medyczne Pratia Poznan, Skórzewo

40-040

Synexus Polska Sp. z o.o., Katowice

42-200

Centrum Medyczne Pratia Czestochowa, Częstochowa

42-202

Synexus Polska Sp. z o.o., Częstochowa

80-382

Synexus Polska Sp. z o.o., Gdansk

81-338

Centrum Medyczne Pratia Gdynia, Gdynia

58-506

Pratia Jelenia Gora, Jelenia Góra

40-081

Centrum Medyczne Pratia Katowice, Katowice

30-727

Pratia MCM Krakow, Krakow

31-501

Krakowskie Centrum Medyczne Sp.z o.o., Krakow

90-127

Synexus Polska Sp. z. o.o., Lodz

91-363

Centrum Medyczne AMED Oddzial w Lodzi, Lodz

60-702

Synexus Polska Sp. z o.o., Poznan

00-215

FutureMeds Warszawa Centrum, Warsaw

02-672

Synexus Polska Sp. z o.o., Warsaw

7 03-291

Centrum Medyczne AMED, Warsaw

50-381

Synexus Polska Sp. z o.o., Wroclaw

53-673

FutureMeds Sp. z o.o., Wroclaw

All Listed Sponsors
lead

Luye Pharma Group Ltd.

INDUSTRY