Effects after starting or switching from bisphosphonate to romosozumab or denosumab in Japanese postmenopausal patients.

Published on Apr 13, 2021in Journal of Bone and Mineral Metabolism2.626
· DOI :10.1007/S00774-021-01226-1
Tomohiro Shimizu11
Estimated H-index: 11
(Hokkaido University),
Kosuke Arita (Hokkaido University)+ 7 AuthorsNorimasa Iwasaki45
Estimated H-index: 45
(Hokkaido University)
Sources
Abstract
Purpose We aimed to investigate the longitudinal changes in bone metabolic markers and bone mineral density (BMD) after starting or switching from bisphosphonate (BP) to romosozumab (ROMO) or denosumab (DENO) therapies over 12 months and to determine predictors that establish associations with changes in BMD among the patients received the ROMO therapy. Methods Postmenopausal osteoporosis patients with a high risk of fracture-154 in total-were recruited; their therapies were switched to ROMO or DENO from BP/naive or vitamin D (ND) (ND-ROMO: 43, BP-ROMO: 38, ND-DENO: 38, and BP-DENO: 35). Longitudinal changes in bone metabolic markers and BMD were evaluated. Results ROMO groups showed significant increases in BMD of the lumbar spine at 6 and 12 months and femoral neck at 12 months compared to the DENO groups. Although BP-ROMO showed significant increase in the lumbar spine BMD compared to BP-DENO, there were no significant differences in femoral neck and total hip BMDs between BP-ROMO and BP-DENO. Among the ROMO groups, % changes of BMD from baseline to 12 months were associated with bone metabolic markers at baseline and changes in TRACP-5b from baseline to 3 months. Conclusions ROMO continuously increased BMD for 12 months and performed better than DENO. On the other hand, effects of ROMO switched from BP on BMD of femoral neck and total hip were almost same with DENO. Bone metabolic markers at baseline and changes in TRACP-5b from baseline to 3 months may predict the efficacy of ROMO after 12 months of administration.
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#2K. WadaH-Index: 1
Last. K. OkazakiH-Index: 1
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Our 6-month study showed the usefulness of romosozumab for preventing fractures and its safety. It was effective in patients with low baseline spine BMD, high TRACP-5b, and high iP1NP. Percent change from baseline of TRACP-5b and iP1NP after 1 month correlated with that from baseline of BMD after four to 6-month treatment. Romosozumab appeared as a new osteoporosis medication in Japan in 2019. It is an anti-sclerostin antibody which increases bone formation and suppresses bone resorption. In thi...
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#1Akimitsu MiyauchiH-Index: 29
#2Etsuro Hamaya (Amgen)H-Index: 1
Last. Junichiro Shimauchi (Amgen)H-Index: 1
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This post-hoc analysis of the FRAME study investigated the long-term efficacy and safety of romosozumab followed by denosumab in postmenopausal Japanese women with osteoporosis at high fracture risk. Data from Japanese women with a high fracture risk participating in the international, randomised, double-blind, placebo-controlled, phase 3 FRAME study were analysed. High risk of fracture was defined as ≥ 1 fragility fracture with bone mineral density (BMD) ≤ − 2.5 standard deviations [SD], > 2 pr...
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#1Masafumi KashiiH-Index: 17
#2Kosuke Ebina (Osaka University)H-Index: 18
Last. Hideki YoshikawaH-Index: 109
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Abstract Discontinuation of denosumab is associated with the increase of bone turnover markers to above-baseline levels (so-called rebound in bone turnover) and rapid bone loss. Several studies have reported vertebral fractures (VFs), particularly multiple spontaneous clinical VFs (MSCVFs), occurring after discontinuation of denosumab. There is currently no recommendation for the management of VFs including MSCVFs. Presently, romosozumab is the strongest anti-osteoporotic agent that inhibits scl...
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#1Kosuke Ebina (Osaka University)H-Index: 18
#2Makoto Hirao (Osaka University)H-Index: 22
Last. Ken Nakata (Osaka University)H-Index: 37
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Abstract Purpose To investigate the effects of prior treatment and the predictors of early treatment response to romosozumab (ROMO) in patients with postmenopausal osteoporosis. Methods In this prospective, observational, multicenter study, 130 treatment-naive patients (Naive; n = 37) or patients previously treated with bisphosphonates (BP; n = 33), denosumab (DMAb; n = 45), or teriparatide (TPTD; n = 15) (age, 75.0 years; T-scores of the lumbar spine [LS] −3.2 and femoral neck [FN] −2.9) were s...
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#1Junichi TakadaH-Index: 2
#2Rajani Dinavahi (Amgen)H-Index: 6
Last. Andreas Grauer (Amgen)H-Index: 35
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Introduction Procollagen type I N-terminal propeptide (P1NP), a bone formation marker, reportedly predicts bone mineral density (BMD) response to teriparatide treatment in treatment-naive patients with osteoporosis. Results from a randomized, phase 3, open-label, active-controlled trial— STRUCTURE—showed that in patients previously treated with bisphosphonates, romosozumab led to gains in hip BMD, which were not observed with teriparatide. This post hoc analysis investigated the comparative util...
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#1Hideaki IshibashiH-Index: 1
#2Daria B. Crittenden (Amgen)H-Index: 15
Last. Andreas Grauer (Amgen)H-Index: 35
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#1Bente L. Langdahl (Aarhus University Hospital)H-Index: 57
#2Cesar Libanati (UCB)H-Index: 12
Last. Andreas Grauer (Amgen)H-Index: 35
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Summary Background Previous bisphosphonate treatment attenuates the bone-forming effect of teriparatide. We compared the effects of 12 months of romosozumab (AMG 785), a sclerostin monoclonal antibody, versus teriparatide on bone mineral density (BMD) in women with postmenopausal osteoporosis transitioning from bisphosphonate therapy. Methods This randomised, phase 3, open-label, active-controlled study was done at 46 sites in North America, Latin America, and Europe. We enrolled women (aged ≥55...
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BackgroundRomosozumab is a monoclonal antibody that binds to and inhibits sclerostin, increases bone formation, and decreases bone resorption. MethodsWe enrolled 4093 postmenopausal women with osteoporosis and a fragility fracture and randomly assigned them in a 1:1 ratio to receive monthly subcutaneous romosozumab (210 mg) or weekly oral alendronate (70 mg) in a blinded fashion for 12 months, followed by open-label alendronate in both groups. The primary end points were the cumulative incidence...
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BackgroundRomosozumab, a monoclonal antibody that binds sclerostin, increases bone formation and decreases bone resorption. MethodsWe enrolled 7180 postmenopausal women who had a T score of –2.5 to –3.5 at the total hip or femoral neck. Patients were randomly assigned to receive subcutaneous injections of romosozumab (at a dose of 210 mg) or placebo monthly for 12 months; thereafter, patients in each group received denosumab for 12 months, at a dose of 60 mg, administered subcutaneously every 6 ...
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