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Summary <p>The impact of romosozumab on the bone mineral density surrogate threshold effect (BMD-STE) in postmenopausal women with severe osteoporosis is unknown. Significant BMD gains with romosozumab were observed and 60% of patients achieved the BMD-STE at month 12, regardless of bisphosphonate pre-exposure. Romosozumab offers effective treatment in high-risk fracture patients.</p> Purpose <p>A real-life study to investigate the impact of romosozumab on the bone mineral density surrogate threshold effect (BMD-STE) for minimal fracture risk reduction.&#xa0;</p> Methods <p>A retrospective analysis of postmenopausal women with severe osteoporosis newly treated with romosozumab from 29 November 2022 until 01 July 2024 (extraction date). BMD of the lumbar spine (L1–L4), femoral neck, and total hip was assessed at baseline and months 6 and 12, and the BMD-STE was evaluated. Blood serum samples were assayed for bone turnover markers and calcium-phosphate metabolism. Subgroup analyses compared patients minimally exposed to bisphosphonates with patients pre-exposed to bisphosphonates. Patients contributed to the analysis according to their observation period.</p> Results <p>Overall, 133 postmenopausal women with severe osteoporosis newly treated with romosozumab were included (mean age 72.5 ± 9.5&#xa0;years, lowest T score -3.3 ± 0.87); 70 patients were followed up to month 6, and 41 patients up to month 12. Significant increases in BMD were observed at all sites (all p &lt; 0.05 vs. baseline). At month 6, 56.4% of patients reached the STE for minimal fracture risk reduction for all fractures. Among patients with a lumbar spine T-score ≤ -2.5 at baseline, 18.2% and 32.0% reached the T-score target (&gt; -2.5) at months 6 and 12, respectively. P1nP levels increased significantly and CTX levels decreased significantly at months 3 and 6, (all p &lt; 0.05 vs. baseline).</p> Conclusion <p>The rapid increase in BMD with romosozumab supports its use for reducing fracture risk in postmenopausal women with severe osteoporosis, regardless of prior bisphosphonate exposure.</p>

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ROMosozumab early experience in female patients with severe osteoporosis in an Italian real-world setting, the ROMEO study

  • 期刊论文

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  • 发表日期：

    2025年10月13日

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  • Giovanni Adami,
  • Marta Bartezaghi,
  • Filippo Montanari,
  • Anna Piccinelli,
  • Francesco Pollastri,
  • Francesca Mastropaolo,
  • Francesco Giorgio,
  • Camilla Benini,
  • Angelo Fassio,
  • Maurizio Rossini,
  • Davide Gatti,
  • Rachele Fornari,
  • Ombretta Viapiana

摘要

Summary

The impact of romosozumab on the bone mineral density surrogate threshold effect (BMD-STE) in postmenopausal women with severe osteoporosis is unknown. Significant BMD gains with romosozumab were observed and 60% of patients achieved the BMD-STE at month 12, regardless of bisphosphonate pre-exposure. Romosozumab offers effective treatment in high-risk fracture patients.

Purpose

A real-life study to investigate the impact of romosozumab on the bone mineral density surrogate threshold effect (BMD-STE) for minimal fracture risk reduction. 

Methods

A retrospective analysis of postmenopausal women with severe osteoporosis newly treated with romosozumab from 29 November 2022 until 01 July 2024 (extraction date). BMD of the lumbar spine (L1–L4), femoral neck, and total hip was assessed at baseline and months 6 and 12, and the BMD-STE was evaluated. Blood serum samples were assayed for bone turnover markers and calcium-phosphate metabolism. Subgroup analyses compared patients minimally exposed to bisphosphonates with patients pre-exposed to bisphosphonates. Patients contributed to the analysis according to their observation period.

Results

Overall, 133 postmenopausal women with severe osteoporosis newly treated with romosozumab were included (mean age 72.5 ± 9.5 years, lowest T score -3.3 ± 0.87); 70 patients were followed up to month 6, and 41 patients up to month 12. Significant increases in BMD were observed at all sites (all p < 0.05 vs. baseline). At month 6, 56.4% of patients reached the STE for minimal fracture risk reduction for all fractures. Among patients with a lumbar spine T-score ≤ -2.5 at baseline, 18.2% and 32.0% reached the T-score target (> -2.5) at months 6 and 12, respectively. P1nP levels increased significantly and CTX levels decreased significantly at months 3 and 6, (all p < 0.05 vs. baseline).

Conclusion

The rapid increase in BMD with romosozumab supports its use for reducing fracture risk in postmenopausal women with severe osteoporosis, regardless of prior bisphosphonate exposure.