ArticleOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2026
Romosozumab super-responders in clinical practice: insights from a large Italian multicenter cohort of women with severe postmenopausal osteoporosis.
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, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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- Clarifying the romosozumab "Super-Responder" phenotype: response to methodological concerns.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Article
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Abstract
Limited data on romosozumab super-responders. In 149 Italian women with severe osteoporosis, mean LS BMD gain was + 13.7%; 18% were super-responders (≥ 20%). PREDICTORS: high CTX/age/low Z-score for LS; prior femoral fracture for FN. Highlights site-specific response drivers in real-world setting. PURPOSE: To evaluate romosozumab effectiveness in a large Italian multicentre cohort of women with severe postmenopausal osteoporosis and identify predictors of high-magnitude densitometric response. Real-world evidence on romosozumab is expanding, yet data on high-magnitude response variability and clinical determinants of "super-responder" phenotypes remain limited.
methodsRetrospective analysis of postmenopausal women who completed 12 months of romosozumab across five Italian centers. DXA scans were performed at baseline and after treatment. Data included clinical history, morphometric and clinical fractures, and prior anti-osteoporotic therapies. "Very good responders" were defined as ≥ 10% BMD gain; "super-responders" as ≥ 20%. Multivariate logistic regression identified independent predictors.
results149 women (mean age 69.4 ± 9.9 years) were included. Prevalent vertebral (85.2%), femoral (30.9%), and non-vertebral (49.0%) fractures were common; 82% had prior therapy. Mean BMD gains were + 13.7% at lumbar spine (LS), + 5.9% at femoral neck (FN), and + 4.4% at total hip (TH). Very good responders (≥ 10%) occurred in 65.2% at LS, 17.8% at FN, and 13.3% at TH; super-responders (≥ 20%) in 17.8% at LS and 5.9% at FN. LS super-response was independently associated with higher baseline CTX (OR 1.42; p = 0.018), older age (OR 1.10 per year; p = 0.036), and lower baseline LS Z-score (OR 0.29; p = 0.003). FN super-response linked to prior femoral fracture (OR 14.6; p = 0.020).
conclusionRomosozumab demonstrated high effectiveness in this real-world cohort, with a substantial proportion achieving high-magnitude BMD responses despite extensive prior treatment. Distinct site-specific predictors emerged: bone turnover and age/Z-score for LS, prior femoral fracture for FN.
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