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

Abstract

Excluding clinical trials, there is limited evidence on the effect of 12 months of romosozumab treatment on bone mineral density (BMD) increase in real-world clinical practice because its use has only been approved recently. Thus, this study aimed to investigate the real-world effect of 12 months of romosozumab treatment on BMD increase and identify factors that predict the rate of BMD increase after 12 months of romosozumab treatment. We retrospectively investigated 106 patients who completed a 12-month romosozumab treatment for osteoporosis with a high risk of fractures at four hospitals from March 2020 to March 2022. The univariate and multiple regression analyses were performed to analyze the concurrent effects of various factors on the BMD increase after the 12-month romosozumab treatment. After 1 year of treatment, the lumbar spine BMD increased by 14.6%, and femoral neck BMD increased by 5.1%. Univariate regression analysis found that male sex, high tartrate-resistant acid phosphatase 5b (TRACP-5b) value before romosozumab administration, absence of osteoporosis medications before romosozumab administration, and low baseline lumbar spine BMD were associated with the extent of lumbar spine BMD increase. Moreover, stepwise multiple regression analysis found that the TRACP-5b value before romosozumab administration was a significant predictor of the rate of lumbar spine BMD increase after 1 year of romosozumab administration. In conclusion, our results demonstrated the effectiveness of the 12-month romosozumab treatment for osteoporosis with a high risk of fractures and the TRACP-5b value before romosozumab administration was a significant predictor of the rate of lumbar spine BMD increase after 1 year of romosozumab administration. Our findings could help establish more efficient treatment strategies for patients with osteoporosis at a high risk of fracture.

Bone loss and new vertebral fractures during treatment with romosozumab: a case-report

“…Of this patient subgroup, only half received fewer than six doses of romosozumab [4]. Realworld data from two Japanese cohort studies reported 3% and 5.7% of patients who suffered new fractures during treatment with romosozumab, of which 1.3% and 1.9% a vertebral fracture [9,10]. A recent retrospective study regarding 92 romosozumab non-responder patients found an absent early rise in P1NP to be a predictor of nonresponse at month 12 [11].…”

Pregnancy and Lactation-Associated Osteoporosis Successfully Treated with Romosozumab: A Case Report

“…Romosozumab has the dual effect of increasing bone formation and suppressing bone resorption, leading to significant increases in BMD [ 34 ]. In Japan, Inose et al (2022) recently reported that 106 osteoporosis patients at a high risk of fracture and treated with romosozumab for 12 months achieved BMD increases of 14.6% at the lumbar spine, 5.1% at the femoral neck, and 3.1% at the total femur [ 35 ]. Romosozumab was less effective for patients with prior treatment consisting of osteoporosis medication such as bisphosphonate, denosumab, and teriparatide [ 36 , 37 ].…”

Impact of romosozumab on serum calcium concentration and factors predicting the fluctuations in calcium concentration upon romosozumab administration: A multicenter retrospective study

“…Romosozumab increases bone density by continuously promoting bone formation and inhibiting bone resorption early after administration ( Cosman et al, 2016 ). A favorable increase in bone density with romosozumab use has been reported ( Cosman et al, 2016 ; Ebina et al, 2021 ; Inose et al, 2022 ; McClung et al, 2014 ). However, despite vitamin D and calcium supplementations during clinical trials, hypocalcemia is considered an adverse effect of romosozumab administration ( Cosman et al, 2016 ; McClung et al, 2014 ).…”