TOPLINE:

Romosozumab significantly increased bone mineral density (BMD) in postmenopausal women with severe osteoporosis after 6 and 12 months, irrespective of prior exposure to bisphosphonates, with over half of women achieving the BMD surrogate threshold effect (BMD-STE) for minimal fracture risk reduction.

METHODOLOGY:

• Researchers conducted a retrospective analysis to determine the proportion of postmenopausal women with severe osteoporosis who achieved the BMD-STE for minimal fracture risk reduction following romosozumab therapy.
• They included 133 postmenopausal women (mean age, 72.5 years; mean age at menopause, 49.2 years) with severe osteoporosis who were treated with at least one dose of romosozumab 210 mg/mo.
• Patients were stratified into two groups: those with minimal exposure to bisphosphonates (< 3 months of continuous use in the previous 2 years) and those with prior exposure (> 3 months of continuous oral treatment or any intravenous use).
• BMDs of the lumbar spine, femoral neck, and total hip were measured using DEXA at baseline and 6 and 12 months.
• Bone turnover markers and calcium-phosphate metabolism were assessed in serum samples at baseline and 3, 6, and 12 months.

TAKEAWAY:

• Romosozumab significantly increased BMD across all measured sites from baseline at 6 and 12 months, with improvement of 3.9% and 6.6% at the femoral neck (P < .01), 3.4% and 3.7% at the total hip (P < .01), and 7.5% and 10.9% at the lumbar spine (P < .0001), respectively.
• Overall, 56.4% of women achieved the STE for minimal fracture risk reduction for all fractures at 6 months, which increased to 60.0% at 12 months; similar improvements were observed for vertebral, hip, and non-vertebral fractures. The percentage of patients achieving STEs was comparable between minimal bisphosphonate exposure and prior exposure groups at every site.
• Levels of procollagen type 1 intact N‑terminal peptide, a bone turnover marker, rose from baseline at 3 and 6 months (P < .01 for both), returning to baseline by 12 months, whereas levels of C‑terminal telopeptide of type 1 collagen (a bone turnover marker) decreased at 3 and 6 months (P < .05 for both) and then gradually rose towards baseline by 12 months.
• Calcium levels significantly decreased from baseline at 3 and 6 months (P < .0001 for both) but returned towards baseline at 12 months, whereas parathyroid hormone levels increased significantly at months 3 and 12 compared with baseline (P < .01 for both). The discontinuation of treatment was seen in 6.8% of patients owing to adverse events.

IN PRACTICE:

"Our findings support the effectiveness of romosozumab as a first-line treatment in patients at imminent risk for fracture (ie, within 6-12 months), in whom a rapid increase in BMD is of the utmost importance," the authors wrote.

SOURCE:

This study was led by Giovanni Adami, MD, Rheumatology Unit, University of Verona, Verona, Italy. It was published online on October 13, 2025, in Osteoporosis International.

LIMITATIONS:

The retrospective design and incomplete follow-up data may have introduced bias, potentially limiting the generalisability of the results. The lack of a control group hindered direct comparisons with other treatment methods.

DISCLOSURES:

This study was supported by UCB and Amgen, and open access funding was provided by Università degli Studi di Verona. Some authors reported receiving advisory board honoraria, consultancy fees, and speaker fees from various pharmaceutical companies. Two authors reported being employees of UCB.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.