A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture

PHASE3CompletedINTERVENTIONAL
Enrollment

514

Participants

Timeline

Start Date

June 17, 2022

Primary Completion Date

December 17, 2023

Study Completion Date

July 3, 2024

Conditions
Postmenopausal
Interventions
BIOLOGICAL

HLX14

"Subjects will receive a total of 3 doses of subcutaneous injection of HLX14 (once every 6 months (Q6M)).~Treatment period 1: D1-D364, subjects will receive subcutaneous injection of HLX14 60mg on D1 and D183.~Treatment period 2: D365-D546, on D365, subjects will be continue with a third dose of HLX14."

BIOLOGICAL

Prolia®

"Subjects will receive a total of 3 doses of subcutaneous injection of HLX14 or Prolia® (once every 6 months (Q6M)).~Treatment period 1: D1-D364, subjects will receive subcutaneous injection of Prolia® 60mg on D1 and D183.~Treatment period 2: D365-D546, on D365, subjects in the Prolia® arm will be re-randomized 1:1 to either continue with a third dose of Prolia® or transition to HLX14 and receive a single dose of HLX14."

Trial Locations (38)

Unknown

The First Hospital of Hebei Medical University, Shijiazhuang

The Fourth Affiliated Hospital of Harbin Medical University, Harbin

Inner Mongolia Baogang hospital, Baotou

Huai'an First People's Hospital, Huai'an

The Second Affiliated Hospital of Nanjing Medical University, Nanjing

Affiliated Hospital of Xuzhou Medical University, Xuzhou

Ruian People's Hospital, Rui'an

People's Hospital of Ningxia Hui Autonomous Region, Yinchuan

Zhejiang Provincial People's Hospital, Hangzhou

Beijing BOAI Hospital, Beijing

Beijing Hospital, Beijing

Beijing Jishuitan Hospital, Beijing

BeiJing PINGGU Hospital, Beijing

The Third Xiangya Hospital of Central South University, Changsha

Changzhou NO.2 People's Hospital, Changzhou

West China Hospital of Sichuan University, Chengdu

Chongqing University three Gorges Hospital, Chongqing

The Second Affiliated Hospital of Chongqing Medical University, Chongqing

Department of Geriatrics, Guangzhou First People's Hospital, Guangzhou

Guangzhou First People's Hospital, Guangzhou

The First Affiliated Hospital of USTC Anhui Provincial Hospital, Hefei

Qilu Hospital of Shandong University, Jinan

Shandong Provincial Hospital, Jinan

Affiliated Hospital of Jining Medical University, Jining

The Third People's Hospital of Yunnan Province, Kunming

Henan Luoyang Orthopedic Hospital, Luoyang

The First Affiliated Hospital of Henan University of Science and Technology, Luoyang

Jiangxi Provincial People's Hospital, Nanchang

Nanchang Hongdu Hospital of traditional Chinese Medicine, Nanchang

Nanchang Third Hospital, Nanchang

Pingxiang Peoples's Hospital, Pingxiang

Suining Central Hospital, Suining

First Hospital of Shanxi Medical University, Taiyuan

Second hospital of Shanxi Medical University, Taiyuan

Tianjin First Central Hospital, Tianjin

Weifang People's Hospital, Weifang

Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology, Wuhan

Honghui Hospital,Xi'an Jiaotong University, Xi'an

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY