UCB, a global biopharmaceutical company, today announced findings from a collection of real-world evidence studies to reaffirm the effectiveness and clinical impact of romosozumab, the only dual-acting osteoporosis treatment that increases bone formation and decreases bone resorption, around the world.3
The data were presented as a poster at the 25th World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) 2025 in Rome, 10-13 April.
A systematic literature review identified 362 records from 67 studies across 10 countries and found that romosozumab was associated with significant improvements in bone mineral density (BMD) at 12 months versus baseline in lumbar spine, total hip and femoral neck studies. BMD gains in treatment-naïve patients were significantly larger compared with previously treated patients, emphasizing the importance of treatment sequencing.1
“This collection of evidence across multiple countries further confirms that treating patients at high fracture risk with romosozumab at the right time plays a crucial role in strengthening bones and significantly reducing fracture risk,” said lead study investigator Prof Bente Langdahl (Clinical Professor, Aarhus University Hospital, Denmark). “By following the established guidelines that advise optimal treatment sequencing, healthcare professionals have the potential to change the trajectory of a patient’s fracture risk.”
At WCO-IOF-ESCEO 2025, UCB is further expanding the real-world evidence base for romosozumab with multiple data readouts:
- A retrospective analysis of healthcare resource utilization in Germany found that total patient costs the year before (11,109 EUR [SD 13,314; median 8,033]) and the year after starting romosozumab (18,630 EUR [SD 24,470; median 12,215] were similar despite the additional cost of the medication. Costs decreased below pre-treatment levels in the second year (5,604 EUR [SD 7,778], indicating potential long-term cost-effectiveness and reduced healthcare burden.2
- In a Swedish registry study on osteoporosis, over three-quarters of patients (76.9%) treated with romosozumab were treatment-naïve, indicating broad adoption of osteoanabolic therapy as a first-line approach.4
- A claims data analysis on women aged 55+ in Germany found gaps in osteoporosis guideline-adherent treatment, with many women with high-risk fractures remaining untreated, leading to more secondary fractures. This highlights the urgent need for adherence to the 2023 Guideline of the Dachverband Osteologie for the Prevention, Diagnosis and Therapy of Osteoporosis in Adults (DVO) guideline, which includes a 3-year fracture risk threshold for timely treatment.5
“We have the opportunity to make this a defining era in osteoporosis management, where no woman at high risk of fracture is overlooked or untreated,” said Emmanuel Caeymaex, Chief Commercial Officer and Head of Patient Impact, UCB. “The growing body of real-world evidence behind romosozumab reinforces our continued commitment of bringing meaningful benefits to patients and provides healthcare professionals with the confidence that romosozumab will deliver significant improvements in the clinical setting.”
Romosozumab was approved in the European Union in December 2019 for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.2
References
- Langdahl B. 2025. WCO-IOF-ESCEO 2025. #943.
- Grotenrath L. 2025. WCO-IOF-ESCEO 2025. #240.
- EVENITY® EU SmPC. Available at https://www.ema.europa.eu/en/documents/product-information/evenity-epar-product-information_en.pdf. Accessed March 2025.
- Lorentzon B.2025. WCO-IOF-ESCEO 2025. #631.
- Melnik S. 2025. WCO-IOF-ESCEO 2025. #892.