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PostmenopausalPhase 3NCT05352516

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

A Phase 3 study testing HLX14 and Prolia® in people with Postmenopausal, run by Shanghai Henlius Biotech at 38 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 90 years, women only
Conditions the study is for
Postmenopausal
What is being tested?
HLX14 and Prolia®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
514 participants
Where
38 sitesChina
Study dates
17 Jun 2022to 3 Jul 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
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  • 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;
  • Having received Denosumab and its biosimilars, or Romosozumab and its biosimilars, cathepsin K inhibitor therapy prior to randomization;
  • Having received the following osteoporosis treatments, or medications that affect bone metabolism or any herbal medications:
  • 1) Use of bisphosphonates(oral or intravenous) ,fluoride and strontium prior to randomization.
  • 2) Use of parathyroid hormone (PTH) or PTH analogues, such as teriparatide, within 12 months prior to randomization.
  • 3) Use of systemic hormone replacement therapy (HRT), selective estrogen receptor modulators, tibolone, anabolic hormones, testosterone, androgens, gonadotropin releasing hormone agonists, adrenocorticotropic hormone, within 12 months prior to randomization.
  • 4) Use of calcitonin, calcitriol, alfacalcidol and vitamin D analogues within 12 months prior to randomization: 5) Use of any of the following within 3 months prior to randomization: heparin, warfarin, anticonvulsants (except benzodiazepines), systemic use of ketoconazole, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and oral or parenteral glucocorticoids (≥ 5 mg/day prednisone daily or equivalent for > 10 days).
  • 6) Use of any herbal medications within 2 weeks (If the herbal medications contain the above components that affect bone metabolism, should follow the corresponding elution period of bone metabolism components);
  • 18. Subjects with a history or presence of hip fracture or .prevalent vertebral (any severe or more than 2 moderate prevalent vertebral fractures);
  • 19. Subjects in active healing fracture in the opinion of the investigator;
  • 20. Subjects at very high risk of fracture who must be treated immediately with an active drug in the opinion of the investigator;
  • 21. Known allergic to the drugs listed in the study protocol, including a history of allergy to denosumab, any recombinant protein drugs, or any ingredients used in HLX14 or Prolia®;
  • 22. With a history and presence of smoking, except for the following suituation:
  • non-smokers (A history of never smoking > 5 cigarettes/day and not smoking at all for at least the last 2 years prior to screening process)
  • light smokers (with smoking habit <5 cigarettes/day, smoking period <10 years. Light smokers should have not smoked more than 1 cigarette in the week before starting the medical screening process)
  • 23. With a history of drug or alcohol abuse, and with evidence of alcohol or drug abuse within 12 months;
  • 24. Various physical or psychiatric disorders or laboratory abnormalities which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of study results. Or the subjects presenting other factors not suitable for participation in the opinion of the investigator.

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

China38 sites

  • Inner Mongolia Baogang hospital

    Baotou, Inner Mongolia

  • 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

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • The First Affiliated Hospital of USTC Anhui Provincial Hospital

    Hefei

  • Huai'an First People's Hospital

    Huai'an, Jiangsu

  • 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

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

  • Pingxiang Peoples's Hospital

    Pingxiang

  • Ruian People's Hospital

    Rui'an, Jiangxi

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • 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

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

  • People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia

Other trials in China

About this study

Official title: 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

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).

Read the detailed description
  • Screening period: From Day -28 to -1, all female with postmenopausal osteoporosis subjects at high risk of fracture sign the informed consent form (ICF) and undergo relevant tests. Those who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned into either experiment group (HLX14) or control group (Prolia®) at 1:1 and then enter the treatment period. Vitamin D and calcium supplementation is allowed during the screening period.
  • Treatment period: 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 HLX14 or 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. Subjects in the HLX14 arm will be continue with a third dose of HLX14.

  • During the treatment period, subjects should taking at least 1000 mg of calcium daily and at least 400 IU of vitamin D daily until the end of study. (Dose will be adjusted by the investigator based on serum calcium)
  • End-of-study visit: The end-of-study visit will be conducted on D547 of the study or premature withdrawal. Only serious adverse events related to the investigational product will be recorded thereafter.
Conditions
Postmenopausal
Being tested
HLX14, Prolia®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX14Biological

    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.

  • Prolia®Biological

    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.

Study groups in NCT05352516
Study groupRoleWhat they receive
Treatment groupExperimentalNot described
Receives: Biological: HLX14
Control groupActive comparatorNot described
Receives: Biological: Prolia®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%

    Measured: 52 Weeks

  2. 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)

    Measured: 26 Weeks

Secondary outcomes (2)

  1. Secondary efficacy endpoint

    1. Percent change from baseline in BMD at the lumbar spine to Week 26 (D183), Week 52 (D365),Week78 (D547) (assessed by investigator).
    2. Fracture rate from baseline to Week 52 (D365), Week 78 (D547).
    3. Percent change in BMD at lumbar spine from baseline to Week 26 (D183), Week 78 (D547) (assessed by the central imaging).
    4. Percent change in BMD at total hip from baseline to Week 26 (D183), Week 52 (D365) and Week 78 (D547) (assessed by the central imaging and investigator).
    5. Percent change in BMD at the femoral neck from baseline to Week 26 (D183), Week 52 (D365) and Week 78 (D547) (assessed by the central imaging and investigator).

    Note: Fracture rate=(number of patients with new fractures/total number of patients)*100% The percent change in BMD is calculated as (test value - baseline value) ÷ (baseline value) × 100%

    Measured: 78 Weeks

  2. Secondary pharmacodynamic endpoint

    1. Relative percent change in serum type I collagen C-telopeptide (s-CTX) from baseline to D15, D29, D57, D92, D106, D134, D162, D183 (within 7 days prior to the second dose), D274, D365 (within 7 days prior to the third dose), and D547 (at the end-of-study visit).
    2. Relative percent changes in serum procollagen type I N propeptide (s-P1NP) from baseline to D15, D29, D57, D92, D106, D134, D162, D183 (within 7 days prior to the second dose), D274, D365 (within 7 days prior to the third dose) and D547 (at the end-of-study visit).

    The relative percent change is calculated as: (Test value at timepoints evaluated - Baseline value) / (Baseline value) × 100%

    Measured: 78 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2022
  2. Study start17 Jun 2022
  3. Primary completion17 Dec 2023
  4. Study completion3 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel-Controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
514 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05352516
Sponsor's protocol ID
HLX14-002-PMOP301
Status last verified
Jul 2024
First submitted
23 Apr 2022
Last updated
20 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xin L, Li Z, Zhang J, Xia Q, Jin P, Xue Q, Zheng X, Tang X, Yuan Z, Shen L, Duan P, Zhang Y, Huo Y, Wang B, Cheng Z, Cao Y, Li L, Zeng Y, Lan L, Lu Y, Mao L, Zhang Z, Chen C, Wang Q, Yu H, Li J, Zhu J. Denosumab biosimilar HLX14 versus EU-denosumab in postmenopausal women at high fracture risk: a randomized, double-blind, multicenter phase 3 trial. Osteoporos Int. 2026 Nov 4. doi: 10.1007/s00198-026-08262-5. Online ahead of print.

    PubMed 42980777

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HLX14 and Prolia® in people with Postmenopausal, run by Shanghai Henlius Biotech at 38 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary efficacy endpoint (time frame: 52 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05352516, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.

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