Effects of prior osteoporosis treatment on early treatment response of romosozumab in patients with postmenopausal osteoporosis

Ebina, Kosuke; Hirao, Makoto; Tsuboi, Hideki; Nagayama, Yoshio; Kashii, Masafumi; Kaneshiro, Shoichi; Miyama, Akira; Nakaya, Hiroyuki; Kunugiza, Yasuo; Okamura, Gensuke; Etani, Yuki; Takami, Kenji; Goshima, Atsushi; Nakata, Ken

doi:10.1016/j.bone.2020.115574

Cited by 35 publications

(19 citation statements)

References 19 publications

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“…It was reported that the presence or absence of vitamin D supplementation during the use of bisphosphonates did not significantly affect a BMD increase ( Nakamura et al, 2017 ). Furthermore, Ebina et al found romosozumab to significantly increase BMD even in a state of vitamin D deficiency/insufficiency ( Ebina et al, 2020 ). Therefore, the treatment of osteoporosis with vitamin D deficiency is an opportunity to produce valuable data, and accumulating evidence on the administration and follow-up of romosozumab treatment is clinically important, especially in Japan.…”

Section: Discussionmentioning

confidence: 99%

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

Kobayakawa¹,

Suzuki

Nakano

et al. 2021

Bone Reports

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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.

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Section: Discussionmentioning

confidence: 99%

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

Kobayakawa¹,

Suzuki

Nakano

et al. 2021

Bone Reports

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“…also consistent with a recent observational study demonstrating smaller BMD increases with romosozumab in women who had received previous antiresorptive therapy. (32) Interpreting the BMD and BTM responses in women transitioning from denosumab to any other therapy is complicated by the dynamic changes in bone remodeling known to occur in the several months following denosumab discontinuation. (20,21) The BMD response during the 12 months of romosozumab after denosumab in our study is, at least in relative terms, greater than is apparent since a significant decrease in bone density would have been expected upon stopping denosumab without further therapy.…”

Section: Discussionmentioning

confidence: 99%

“…( 30,31 ) Our results are also consistent with a recent observational study demonstrating smaller BMD increases with romosozumab in women who had received previous antiresorptive therapy. ( 32 )…”

Section: Discussionmentioning

confidence: 99%

Skeletal responses to romosozumab after 12 months of denosumab

McClung

Bolognese²,

Brown

et al. 2021

JBMR Plus

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“…The variables considered for propensity score matching were age, body mass index (BMI), lumbar spine BMD, prevalent vertebral fracture, and prior non-vertebral fracture after 45 years of age. Denosumab (60 mg, s.c. once every 6 months) and romosozumab (210 mg, s.c. once every month) were used to treat patients diagnosed as having postmenopausal osteoporosis [8,10], especially those with a high risk of fracture 12 . Patients were excluded if they had experienced a cardiovascular event within the previous year or were hypocalcemic.…”

Section: Study Populationmentioning

confidence: 99%

“…In recent clinical practice, denosumab [5][6][7] and romosozumab [8][9][10] have become well-known moleculartargeted drugs with potent BMD-increasing effects. The drugs are considered especially important for osteoporosis management.…”

Section: Introductionmentioning

confidence: 99%

Denosumab Versus Romosozumab for Postmenopausal Treatment

Kobayakawa¹,

Miyazaki

Saito³

et al. 2021

Preprint

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INTRODUCTION Denosumab and romosozumab, the recently approved new drug, are effective and widely known molecular-targeted drugs for postmenopausal osteoporosis treatment. However, no studies have directly compared their therapeutic effects or safety in postmenopausal osteoporosis. We believe the data evaluating the efficacy of each drug might be strong ground for further osteoporosis treatment. METHODS This retrospective observational registry study compared the efficacy of 12-month denosumab or romosozumab treatment in postmenopausal osteoporosis patients. The primary outcome was the change in bone mineral density (BMD) at the lumbar spine. Secondary outcomes included BMD changes at the total hip and femoral neck, changes in bone turnover markers, and adverse events. Propensity score matching was employed to assemble patient groups with similar baseline characteristics. RESULTS Sixty-nine patients each received either denosumab or romosozumab for 12 months. The mean 12-month percentage change from baseline in lumbar spine BMD was 7.2% in the denosumab group and 12.5% in the romosozumab group, indicating a significant difference between the groups. The percentage changes in BMD at both the total hip and femoral neck were also significantly higher at 12 months in the romosozumab group than in the denosumab group. In denosumab patients, bone formation and bone resorption markers were significantly decreased at 6 and 12 months from baseline. In the romosozumab group, the bone formation marker was significantly increased at 6 months and then returned to baseline, while the bone resorption marker was significantly decreased at both time points. Adverse events were few and predominantly minor in both groups. CONCLUSION Romosozumab showed a higher potential for improving BMD than denosumab in this clinical study of postmenopausal osteoporosis patient treatment.

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Effects of prior osteoporosis treatment on early treatment response of romosozumab in patients with postmenopausal osteoporosis

Cited by 35 publications

References 19 publications

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

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

Skeletal responses to romosozumab after 12 months of denosumab

Denosumab Versus Romosozumab for Postmenopausal Treatment

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