Randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of the denosumab biosimilar MW031 in Chinese postmenopausal women with osteoporosis

ABSTRACT

Background

This study aimed to assess the efficacy and safety of MW031 in Chinese postmenopausal women with osteoporosis.

Patients and methods

In this randomized, double-blind, placebo-controlled, multicenter clinical trial, 448 postmenopausal women with osteoporosis were randomized 3:1 to receive MW031 and placebo for 12 months. The primary efficacy endpoint was the percentage change from baseline in BMD at lumbar spine in month 12. The safety and immunogenicity profiles were also included.

Results

Of 448 randomized patients, 421 completed the study (MW031, n = 322; placebo, n = 99).After 12 months of MW031 treatment, BMD increased by 5.80% at lumbar spine,3.65% at total hip, and 2.93% at femoral neck. The model-adjusted difference was 3.86% (P<0.0001), 2.34% (P<0.0001), and 1.05% (p = 0.08) compared with placebo group, respectively. For the bone turnover markers, serum CTX level in MW031 group decreased to the maximum difference in month 1 (−71.71%, 95% CI: −77.83%, −65.60%, P<0.0001) compared with the placebo group. The safety analysis showed no significant differences in the proportion of patients reporting any adverse events between the two groups.

Conclusion

This study demonstrated that MW031 safely and effectively increased BMD and rapidly decreased the level of bone resorption marker in Chinese postmenopausal women with osteoporosis.

Trial registration

NCT05215977 (ClinicalTrials.gov.)

KEYWORDS:

• Denosumab
• efficacy
• MW031
• postmenopausal women
• safety

Declaration of interest

Z Hu, Y Xiao, W Ma and Y Guo are employees of the study sponsor, Mabwell (Shanghai) Bioscience Co., Ltd., at the time of study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethics statement

The study was conducted in accordance with the Declaration of Helsinki, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, and the requirements of all the applicable local regulatory authorities. The study protocol was approved by the institutional review boards of all the study sites, and informed consent was obtained from all patients.

Author contributions

W Xia, Y Jiang, Y Guo and Z Hu conceived and designed research; W Xia, Y Jiang, Y Huo, Y Li, X Kong, B Wang, F Liu, X Zheng, Y Li, Y Yang, Y Xu, Q Xue, Z Mo and Y Xiao collected data and conducted research; W Yu reviewed the DXA results and analyzed BMD data as a director of independent review committee; Y Jiang, Y Guo and W Ma wrote the initial paper; W Ma and Y Jiang analyzed and interpreted data; Y Jiang, Y Guo and W Xia revised the paper; W Xia was primarily responsible for the final content. All authors read and approved the final paper.

Data availability statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Acknowledgments

We are grateful to the subjects who participated in this study.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

This study was sponsored by Mabwell (Shanghai) Bioscience Co., Ltd and funded by National Key R&D Program of China [2021YFC2501700], CAMS Innovation Fund for Medical Sciences (CIFMS) [2021-I2M-1-002], National High Level Hospital Clinical Research Funding [2022-PUMCH-D-006 and 2022-PUMCH-B-014].