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Efficacy and safety of odanacatib for osteoporosis treatment: a systematic review and meta-analysis

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Abstract

Purpose

Osteoporosis is a metabolic bone disease that commonly results in middle-aged and elderly people following fractures. Odanacatib (ODN), a potential osteoporosis medication, was stopped in the Long-term Odanacatib Fracture Trial (LOFT) phase III study because it increased the risk of stroke. Herein, we conducted a systematic review and meta-analysis to further assess the efficacy and safety of ODN in osteoporosis treatment.

Methods

We searched the PubMed, EMBASE, Cochrane Library, and Web of Science, using the core search terms “osteoporosis” and “odanacatib.” The primary outcomes were the percentage change in markers of bone turnover and bone formation as well as that in the bone mineral density (BMD) of the lumbar spine, hip, femoral neck, and greater trochanter. The secondary outcome was the risk of adverse events (AEs), used to explore the safety of ODN.

Results

Ten articles—all double-blinded, randomized, placebo-controlled trials—were included. All trials were considered to be of high quality if they met the inclusion and exclusion criteria. We found that ODN increases BMD in the lumbar spine, total hip, and femoral neck, whereas it decreases the concentration of serum C-telopeptides of type I collagen (sCTx) and urinary N-telopeptide/creatinine ratio (uNTx/Cr). We found no significant differences in total, drug-related, serious, or skin AEs between the ODN and control groups. However, significant differences in fracture and stroke AEs were found between the ODN and control groups.

Conclusion

ODN is an appealing long-term osteoporosis treatment method; however, further research should focus on the potential increased risk of fracture and stroke.

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Data availability

All data and materials are available from the medical records department of Lanzhou University Second Hospital. The datasets used and analyzed during the study are available from the corresponding author on reasonable request.

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Funding

This work was supported by the National Natural Science Foundation of China (81874017, 81960403, and 82060405), the Lanzhou Science and Technology Plan Program (2021-RC-102), the Natural Science Foundation of Gansu Province (22JR5RA943 and 22JR5RA956), and the Cuiying Scientific and Technological Innovation Program of Lanzhou University Second Hospital (CY2021-MS-A07).

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Authors and Affiliations

  1. Department of Orthopedics, Lanzhou University Second Hospital; Orthopedics Key Laboratory of Gansu Province; Orthopedics Clinical Research Center of Gansu Province, Lanzhou University Second Hospital, No. 82 Cuiyingmen, Chengguan District, Lanzhou, 730030, Gansu Province, China

    Rongjin Chen, Changshun Chen, Bin Geng, Chenhui Yang, Hefang Xiao, Fei Yang, Hao Wang & Yayi Xia

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  1. Rongjin Chen
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  2. Changshun Chen
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  7. Hao Wang
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Contributions

Rongjin Chen and Changshun Chen were co-first authors who contributed equally to this work. Rongjin Chen and Changshun Chen conceived and designed the study, and wrote the paper. Bin Geng, Chenhui Yang, Hefang Xiao, Fei Yang and Hao Wang consulted the literature, and acquired and analyzed the data. Yayi Xia contributed to the design of the study and critical revision of the manuscript for important intellectual content. All authors contributed to the article and approved the submitted version.

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Correspondence to Yayi Xia.

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Chen, R., Chen, C., Geng, B. et al. Efficacy and safety of odanacatib for osteoporosis treatment: a systematic review and meta-analysis. Arch Osteoporos 18, 67 (2023). https://doi.org/10.1007/s11657-023-01261-7

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