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

  • STATUS
    Recruiting
  • End date
    Apr 15, 2024
  • participants needed
    430
  • sponsor
    Shanghai Henlius Biotech
Updated on 29 July 2022

Summary

This is a randomized, double-blind, international multicentre, parallel-controlled phase III clinical study. The study plans to enroll 430 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 (Cycle 1 and Cycle 2, 52 weeks in total), and an end-of-study visit.

Details
Condition Postmenopausal
Treatment Prolia®, HLX14
Clinical Study IdentifierNCT05352516
SponsorShanghai Henlius Biotech
Last Modified on29 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Ambulatory postmenopausal women with osteoporosis aged 50-90 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

Exclusion Criteria

Diseases that may affect bone metabolism
With serious primary diseases in the cardiovascular, cerebrovascular, or hematopoietic system
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