Real-world effects and adverse events of romosozumab in Japanese osteoporotic patients: A prospective cohort study

Abstract

Real-world data on the new anti-sclerostin antibody drug, romosozumab, remain scarce. There is a strong need to accumulate and analyze data on romosozumab treatment for such conditions as osteoporosis. The purpose of this study was to investigate the therapeutic and adverse effects of romosozumab for osteoporosis treatment in clinical practice. Of the 230 osteoporosis patients prescribed romosozumab from September 2019 in this prospective multicenter cohort study, 204 patients completed 12 months of treatment. The primary outcome of interest was the rate of change in bone mineral density (BMD) of the lumbar spine, total hip, and femoral neck as measured by dual-energy X-ray absorptiometry. Secondary outcomes included changes in bone turnover markers and serum-corrected calcium level as well as the incidence of adverse events. At 6 and 12 months of romosozumab treatment, the respective percentage change in BMD from baseline was 7.4% and 12.2% for the lumbar spine, 1.8% and 5.8% for the total hip, and 2.9% and 6.0% for the femoral neck, all of which were significantly higher ( P < 0.001) than baseline values. Patients who switched from another osteoporosis regimen exhibited significantly lower lumbar spine BMD gains versus treatment-naïve patients, especially for cases switching from denosumab. P1NP was significantly increased at 6 months (58.9%; P < 0.01), while TRACP-5b was significantly decreased at 6 months (−14.7%; P < 0.001) and 12 months (−18.8%; P < 0.001) versus baseline values. The largest rate of decrease in serum-corrected calcium was 3.7% at 12 months. Sixty-four (27.8%) of 230 patients experienced an adverse event, and 7 (3.0%) new fractures were recorded. In sum, romosozumab treatment for 12 months significantly improved lumbar spine, total hip, and femoral neck BMD according to real-world data.

Romosozumab and antiresorptive treatment: the importance of treatment sequence

“…In that study, BMD gains differed significantly in previously untreated patients, patients previously treated with bisphosphonates, or patients previously treated with denosumab; at the total hip, mean BMD gains were 5.6%, 3.3%, and 0.6%, respectively, and at the lumbar spine, mean BMD gains were 18.2%, 10.2%, and 6.4%, respectively. Similar BMD gains at the total hip and lumbar spine were also reported in another prospective real-world study in which previously untreated patients and patients previously treated with bisphosphonates or denosumab were treated with romosozumab for 12 months [ 36 ] and in a retrospective real-world study in which previously untreated patients and patients previously treated with bisphosphonates were treated with romosozumab for 12 months [ 37 ].…”

The Real‐World Effect of 12 Months of Romosozumab Treatment on Patients With Osteoporosis With a High Risk of Fracture and Factors Predicting the Rate of Bone Mass Increase: A Multicenter Retrospective Study

“…These BMD‐increasing effects are generally similar to those observed in previous reports. ( 9–14 ) Thus, these results suggest that romosozumab can be recommended for patients who fit the criteria for osteoporosis with a high risk of fracture.…”

“…Because the drug has only been approved recently, there are few reports on 12‐month romosozumab treatment for patients with osteoporosis in actual clinical practice. ( 12 , 13 , 14 ) Although romosozumab has been found to be less effective in patients receiving osteoporosis medications, such as bisphosphonates, denosumab, or teriparatide, before receiving romosozumab, ( 13 , 14 , 15 ) it is still difficult to predict in which patients it will be ineffective. Therefore, this multicenter retrospective study aimed to determine the real‐world effect of romosozumab on BMD and identify factors that predict the rate of BMD increase after 12 months of romosozumab treatment.…”

Definition and management of very high fracture risk in women with postmenopausal osteoporosis: a position statement from the Brazilian Society of Endocrinology and Metabolism (SBEM) and the Brazilian Association of Bone Assessment and Metabolism (ABRASSO)

“…However, in recent randomized clinical trials and metaanalyses, TPTD and abaloparatide have demonstrated increases in BMD at both trabecular and cortical sites, resulting in fracture risk reduction regardless of prior bisphosphonate treatment (16,76,80). Romosozumab following bisphosphonate therapy has demonstrated BMD gains at the LS and hip sites, although more modest than in treatment-naïve patients (81,82). A randomized trial comparing TPTD with romosozumab therapy for 12 months in postmenopausal women previously treated with bisphosphonates (mostly alendronate) for a mean period of 6 years has shown significant greater increments in BMD at the LS, TH, and FN with romosozumab than TPTD (83).…”