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

NCT05352516 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 514

Last updated 2024-09-20

No results posted yet for this study

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).

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-17
Primary Completion
2023-12-17
Completion
2024-07-03
FDA Drug
Yes

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 NCT05352516 on ClinicalTrials.gov