Abstract
The long-term effects of zoledronate treatment in women with postmenopausal osteoporosis who stop denosumab therapy when they become osteopenic are not known. In a prospective, randomized, controlled clinical trial we previously reported that a single intravenous infusion of zoledronate 5 mg given to such patients 6 months after the last denosumab injection effectively prevents bone loss in the majority of them for up to 3 years. The study was extended for an additional 2 years and included all 19 patients from one Trial Site of the total 27 patients originally randomized in the zoledronate arm. Baseline characteristics of this cohort treated with denosumab for 2.4 ± 0.2 years were not different from those of the whole initial cohort or from the patients who did not participate in this extension. At the end of 5 years 7 patients had become again osteoporotic requiring additional treatment, 9 remained osteopenic while 3 did not complete the study extension. Thus, more than half of the osteoporotic women who became osteopenic with denosumab treatment and stopped it, maintained the BMD gains 5 years after a single zoledronate infusion with no additional treatment. Whether these results are also applicable to patients treated with denosumab for longer periods remains to be established.
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Conception of the hypothesis of the study: ADA. Design of the study: ADA. Acquisition, analysis, interpretation of data: ADA, PM, SAP, SEP. Drafting the manuscript: ADA. Revising the work critically for important intellectual content: PM, SAP, SEP. Final approval of the submitted version: ADA, PM, SAP, SEP. Agreement to be accountable for all aspects of the work: ADA, PM, SAP, SEP.
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Athanasios D. Anastasilakis reports lecture fees from Amgen, Bianex, Eli-Lilly, Galenica, ITF, Unifarma, and UCB; Polyzois Makras reports fees for lectures/advisory boards and research grants from Amgen and fees for lectures/advisory boards from UCB, Elpen, and Galenica; Stergios A. Polyzos has nothing to declare; Socrates E. Papapoulos reports consulting/speaking fees from Amgen, Entera Bio, Qualix Dot, Radius Health, and UCB.
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All procedures performed in the study were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study was approved by the local ethics committee.
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Anastasilakis, A.D., Makras, P., Polyzos, S.A. et al. The Five-Year Effect of a Single Zoledronate Infusion on Bone Mineral Density Following Denosumab Discontinuation in Women with Postmenopausal Osteoporosis. Calcif Tissue Int 113, 469–473 (2023). https://doi.org/10.1007/s00223-023-01119-7
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DOI: https://doi.org/10.1007/s00223-023-01119-7