A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Wome… (NCT05352516) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture
China514 participantsStarted 2022-06-17
Plain-language 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).
Who can participate
Age range
60 Years – 90 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Diseases that may affect bone metabolism;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.