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Summary <p>This study investigated the timing and effects of zoledronate infusions in long-term denosumab users having reached T-score targets (BMD &gt; -2.0&#xa0;T-score). Findings support that early and multiple zoledronate injections are needed to preserve as much BMD as possible after stopping denosumab.</p> Purpose <p>This study evaluated the effects of zoledronate (Zol) administration and the need for multiple infusions to prevent bone loss after stopping denosumab (Dmab) in long-term users, and the influence of previous bisphosphonates (BPs) exposure.</p> Methods <p>This was a multicentric, randomized, open-label study, including 44 post-menopausal women treated with Dmab &gt; 2&#xa0;years and reaching BMD T-scores &gt; -2.0. Patients without pre-Dmab BPs were randomized into 3 groups receiving Zol at 6&#xa0;months (6&#xa0;M, n = 12) or 9&#xa0;months (9&#xa0;M, n = 11) after the last Dmab, or to a group receiving Zol if CTX &gt; 644&#xa0;ng/l or BMD decreased ≥ 5% (OBS, n = 11). A parallel observational group exposed to pre-Dmab BPs (OBS-BPs, n = 10) received Zol under the same criteria as the OBS group. Zol was re-administered during the 2‑year follow‑up according to CTX threshold or BMD loss criteria. Co-primary outcomes were lumbar spine BMD changes 1-year post-Zol and frequency of Zol treatments required.</p> Results <p>A majority of post-Dmab patients without previous BPs required multiple Zol infusions (median 2, range 1–5), while most patients in OBS group with previous BPs needed only one Zol. Median LS BMD changes 12 and 24&#xa0;months post-Zol were similar between groups. However, LS BMD changes at 12&#xa0;months after the end of the last Dmab dose effect were numerically larger in 9&#xa0;M group (-8.25%) and OBS group (-8.13%) than in 6&#xa0;M (-4.71%) and OBS-BPs (-4.62%) groups.</p> Conclusion <p>Findings support that early and multiple Zol injections are needed better to preserve BMD after stopping Dmab in long-term users.</p>

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Preventing post-denosumab bone loss with zoledronate: a 2-year randomized trial in post-menopausal women without and with pre-exposure to bisphosphonates

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月29日

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  • Serge Ferrari,
  • Magaly Hars,
  • Emmanuel Biver,
  • Brigitte Uebelhart,
  • Anne-Catherine Joly,
  • François Herrmann,
  • Christian Meier,
  • Kurt Lippuner

摘要

Summary

This study investigated the timing and effects of zoledronate infusions in long-term denosumab users having reached T-score targets (BMD > -2.0 T-score). Findings support that early and multiple zoledronate injections are needed to preserve as much BMD as possible after stopping denosumab.

Purpose

This study evaluated the effects of zoledronate (Zol) administration and the need for multiple infusions to prevent bone loss after stopping denosumab (Dmab) in long-term users, and the influence of previous bisphosphonates (BPs) exposure.

Methods

This was a multicentric, randomized, open-label study, including 44 post-menopausal women treated with Dmab > 2 years and reaching BMD T-scores > -2.0. Patients without pre-Dmab BPs were randomized into 3 groups receiving Zol at 6 months (6 M, n = 12) or 9 months (9 M, n = 11) after the last Dmab, or to a group receiving Zol if CTX > 644 ng/l or BMD decreased ≥ 5% (OBS, n = 11). A parallel observational group exposed to pre-Dmab BPs (OBS-BPs, n = 10) received Zol under the same criteria as the OBS group. Zol was re-administered during the 2‑year follow‑up according to CTX threshold or BMD loss criteria. Co-primary outcomes were lumbar spine BMD changes 1-year post-Zol and frequency of Zol treatments required.

Results

A majority of post-Dmab patients without previous BPs required multiple Zol infusions (median 2, range 1–5), while most patients in OBS group with previous BPs needed only one Zol. Median LS BMD changes 12 and 24 months post-Zol were similar between groups. However, LS BMD changes at 12 months after the end of the last Dmab dose effect were numerically larger in 9 M group (-8.25%) and OBS group (-8.13%) than in 6 M (-4.71%) and OBS-BPs (-4.62%) groups.

Conclusion

Findings support that early and multiple Zol injections are needed better to preserve BMD after stopping Dmab in long-term users.