ArticleOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2025
ROMosozumab early experience in female patients with severe osteoporosis in an Italian real-world setting, the ROMEO study.
Article in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed.
- Preventing Hip (Proximal Femoral) Fractures: An Evidence-Based Review for Clinicians.Journal of clinical medicine · 2026Review
- Romosozumab in postmenopausal women with classical Osteogenesis imperfecta.Archives of osteoporosis · 2026Article
- Romosozumab super-responders in clinical practice: insights from a large Italian multicenter cohort of women with severe postmenopausal osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Article
- Very short-term monitoring of Romosozumab longitudinal effects in a cohort of postmenopausal women by means of Radiofrequency Echographic Multi-Spectrometry (REMS) technology.Aging clinical and experimental research · 2026Article
- Predicting poor response to anti-osteoporosis therapy: a machine learning model integrating clinical and novel biomarker data.Frontiers in medicine · 2026Article
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Abstract
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.
methodsA 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.
resultsOverall, 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).
conclusionThe rapid increase in BMD with romosozumab supports its use for reducing fracture risk in postmenopausal women with severe osteoporosis, regardless of prior bisphosphonate exposure.
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