Romosozumab in severe postmenopausal osteoporosis-real-world data from 192 women

Romosozumab, used to treat severe osteoporosis, still lacks real-world treatment data. We observed significant gains in spinal and hip bone mineral density, as well as improvements in trabecular microarchitecture. These real-world observations corroborate controlled trials and provide new insights into sequential therapy effects and the management of severe osteoporosis.

Osteoporosis is a common disease that leads to fractures causing immobility and pain. Pharmacological therapy plays a pivotal role in osteoporosis management with a growing number of approved drugs. Romosozumab, an anti-sclerostin antibody, is approved in several countries for the treatment of severe osteoporosis in postmenopausal women. Clinical trials have demonstrated significant gain of areal bone mineral density (aBMD) in these patients over 12 months of treatment; however, real-world data is still limited.

From 2020 to 2024, 192 postmenopausal women with severe osteoporosis treated with romosozumab were identified at our institution. Clinical data from a 24-month observation period were analyzed, comprising aBMD by dual-energy X-ray absorptiometry (DXA), bone microstructure by high-resolution peripheral quantitative computed tomography (HR-pQCT), and biochemical bone turnover markers.

Patients treated with romosozumab showed significant gains in spinal (L1-L4) and hip aBMD (lumbar spine: 14.47 ± 8.74%, p < 0.001; total hip: 4.15 ± 5.92%, p < 0.001), accompanied by an increase in bone formation parameters after 6 months and an increase in trabecular microarchitectural parameters assessed by HR-pQCT in 12-month follow-up. These changes were significantly lower in patients with previous bone specific treatment. Treatment-naïve (TN) patients benefited significantly more than those previously treated with antiresorptive (AR) medication (lumbar spine aBMD change: TN: 17.74 ± 8.30%, AR: 10.44 ± 7.67%, p < 0.001). This was supported by the dependency of aBMD gain on baseline bone formation markers.

Our real-world data corroborate the results from controlled studies and provide new insights into microstructural changes as well as biochemical treatment monitoring. To fully evaluate sequential therapy, larger studies and longer observation times are needed in the future.