A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture
A Randomized, Double-Blind, International Multicentre, Parallel-Controlled Phase III Clinical Study to Evaluate Recombinant Anti-RANKL Human Monoclonal Antibody Injection (HLX14) Versus Denosumab Injection (Prolia®) in Postmenopausal Women With Osteoporosis at High Risk of Fracture
1 other identifier
interventional
514
1 country
38
Brief Summary
This is a randomized, double-blind, international multicentre, parallel-controlled phase III clinical study. The study plans to enroll 478 postmenopausal women with osteoporosis at high risk of fracture, whom will be randomized at 1:1 to either the experiment group (HLX14) or the control group (Prolia®) based on stratification factors (BMI (\< 25, 25-30, \> 30) and geographic region (Asian or non-Asian)). The study includes screening period (28 days), treatment period (total 546 days, contain treatment period 1: D1-D364, treatment period 2: D365-D546), and an end-of-study visit (D547).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2022
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2022
CompletedFirst Posted
Study publicly available on registry
April 28, 2022
CompletedStudy Start
First participant enrolled
June 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2024
CompletedSeptember 20, 2024
July 1, 2024
1.5 years
April 23, 2022
September 17, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Primary efficacy endpoint
Percent change from baseline in BMD at the lumbar spine to Week 52 (D365) (assessed by the central imaging). Note: The percent change in BMD is calculated as: (Test value - Baseline value) / (Baseline Value) × 100%
52 Weeks
Primary pharmacodynamic endpoint
Area under the effect-time curve for percent change from baseline of serum type I collagen C-telopeptide (s-CTX) from 0 to Week 26 (D183) (AUEC0-26W)
26 Weeks
Secondary Outcomes (2)
Secondary efficacy endpoint
78 Weeks
Secondary pharmacodynamic endpoint
78 Weeks
Study Arms (2)
Treatment group
EXPERIMENTALControl group
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Ambulatory postmenopausal women with osteoporosis aged 60-90 years (both inclusive);
- Postmenopausal, defined as \> 2 years of menopause, i.e., \> 2 years of spontaneous amenorrhea or \> 2 years after bilateral oophorectomy;
- Bone mineral density (BMD) T-score between -2.5 and -4.0 at the lumbar spine or total hip, i.e., -4.0 \< T-score ≤ -2.5, as assessed by the central imaging vendor at the time of screening, based on dual-energy x-ray absorptiometry (DXA) scans;
- At least 2 vertebrae in the L1-L4 region of lumbar spine and at least one hip are evaluable by DXA, assessed by the central imaging
You may not qualify if:
- Diseases that may affect bone metabolism;
- Thyroid disorders;
- With serious primary diseases in the cardiovascular, cerebrovascular, or hematopoietic system;
- Subjects with rheumatoid arthritis or ankylosing spondylitis;
- Malabsorption syndrome or various gastrointestinal disorders associated with malabsorption;
- Severe renal impairment due to renal disease with a glomerular filtration rate \< 30 mL/min;
- Hepatic diseases;
- With serious primary diseases in the cardiovascular, cerebrovascular, or hematopoietic system judged by investigator;
- Positive for human immunodeficiency virus (HIV) antibody;
- Vitamin D deficiency;
- Abnormal serum calcium;
- Oral and dental diseases;
- Active or uncontrolled infection requiring systemic therapy within 2 weeks prior to first dose;
- Type 1 diabetic patients, or type 2 diabetic patients who have poor blood glucose control or are treated with insulin, glucagon-like peptide-1 (GLP-1), thiazolidinediones, SGLT2 inhibitors, etc;
- Participating in clinical trials of other medical devices or drugs or reaching less than 30 days or 5 half-lives after the last visit in the clinical trials of other medical devices or drugs (non-bone metabolism related drugs) (whichever is longer, calculated from the date of ICF signing). Bone metabolism related drugs should comply with the corresponding prohibition time limit, and anti-osteoporosis drugs should be excluded. Those who have failed in the screening period of other clinical trials but have not yet been treated with drugs/clinical devices can be included in this study;
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Inner Mongolia Baogang hospital
Baotou, Inner Mongolia, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Ruian People's Hospital
Rui'an, Jiangxi, China
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Beijing BOAI Hospital
Beijing, China
Beijing Hospital
Beijing, China
Beijing Jishuitan Hospital
Beijing, China
BeiJing PINGGU Hospital
Beijing, China
The Third Xiangya Hospital of Central South University
Changsha, China
Changzhou NO.2 People's Hospital
Changzhou, China
West China Hospital of Sichuan University
Chengdu, China
Chongqing University three Gorges Hospital
Chongqing, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Department of Geriatrics, Guangzhou First People's Hospital
Guangzhou, China
Guangzhou First People's Hospital
Guangzhou, China
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, China
Qilu Hospital of Shandong University
Jinan, China
Shandong Provincial Hospital
Jinan, China
Affiliated Hospital of Jining Medical University
Jining, China
The Third People's Hospital of Yunnan Province
Kunming, China
Henan Luoyang Orthopedic Hospital
Luoyang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Jiangxi Provincial People's Hospital
Nanchang, China
Nanchang Hongdu Hospital of traditional Chinese Medicine
Nanchang, China
Nanchang Third Hospital
Nanchang, China
Pingxiang Peoples's Hospital
Pingxiang, China
Suining Central Hospital
Suining, China
First Hospital of Shanxi Medical University
Taiyuan, China
Second hospital of Shanxi Medical University
Taiyuan, China
Tianjin First Central Hospital
Tianjin, China
Weifang People's Hospital
Weifang, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
Wuhan, China
Honghui Hospital,Xi'an Jiaotong University
Xi'an, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2022
First Posted
April 28, 2022
Study Start
June 17, 2022
Primary Completion
December 17, 2023
Study Completion
July 3, 2024
Last Updated
September 20, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share