Treatment patterns in patients with osteoporosis at high risk of fracture in Japan: retrospective chart review

Fujiwara, Saeko; Miyauchi, Akimitsu; Hamaya, Etsuro; Nicholls, Rebecca; Weston, Adèle R.; Baidya, Santwona; Pinto, Lionel; Barron, Rich; Takada, Junichi

doi:10.1007/s11657-018-0443-7

Cited by 20 publications

(12 citation statements)

References 15 publications

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“…While a majority of Japanese postmenopausal women with osteoporosis receive an antiresorptive agent as their initial treatment [ 24 ], the available evidence from global clinical research supports rebuilding the skeletal foundation with romosozumab, followed by antiresorptive therapy with denosumab. This treatment sequence offers patients rapid BMD increases and fracture reduction benefits that are sustained over time [ 7 , 33 ].…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…The most commonly prescribed initial therapy for the treatment of osteoporosis in Japan is an antiresorptive agent (oral bisphosphonate, selective estrogen receptor modulator, eldecalcitol, or denosumab) [ 24 ]. In Japan, two forms of teriparatide treatment are available: a subcutaneous injection of teriparatide acetate at 56.5 μg/week [ 25 ] and a subcutaneous injection of recombinant human teriparatide at 20 μg/day [ 13 , 24 ]. A possible alternative for the treatment of osteoporosis is the bone-forming agent romosozumab, a monoclonal antibody that binds sclerostin, leading to the dual effect of increasing bone formation and decreasing bone resorption [ 26 , 27 ].…”

Section: Introductionmentioning

confidence: 99%

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Increased bone mineral density for 1 year of romosozumab, vs placebo, followed by 2 years of denosumab in the Japanese subgroup of the pivotal FRAME trial and extension

Miyauchi¹,

Dinavahi

Crittenden

et al. 2019

Arch Osteoporos

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Summary Romosozumab, which binds sclerostin, rebuilds the skeletal foundation before transitioning to antiresorptive treatment. This subgroup analysis of an international, randomized, double-blind study in postmenopausal women with osteoporosis showed efficacy and safety outcomes for romosozumab followed by denosumab in Japanese women were generally consistent with those for the overall population. Purpose In the international, randomized, double-blind, phase 3 FRActure study, in postmenopausal woMen with ostEoporosis (FRAME; NCT01575834), romosozumab followed by denosumab significantly improved bone mineral density (BMD) and reduced fracture risk. This report evaluates Japanese women in FRAME. Methods Postmenopausal women with osteoporosis (T-score − 3.5 to − 2.5 at total hip or femoral neck) received romosozumab 210 mg or placebo subcutaneously monthly for 12 months, then each group received denosumab 60 mg subcutaneously every 6 months for 24 months. The key endpoint for Japanese women was BMD change. Other endpoints included new vertebral, clinical, and nonvertebral fracture; the subgroup analysis did not have adequate power to demonstrate statistically significant reductions. Results Of 7180 enrolled subjects, 492 (6.9%) were Japanese (247 romosozumab, 245 placebo). BMD increases from baseline were greater ( P < 0.001) for romosozumab-to-denosumab than placebo-to-denosumab at the lumbar spine (36 months, 12.7%), total hip (4.2%), and femoral neck (4.1%). Fracture risk was lower through 36 months for romosozumab-to-denosumab vs placebo-to-denosumab for new vertebral (1.7% vs 4.5%; relative risk reduction (RRR) 63%, P = 0.070), clinical (3.2% vs 7.3%; RRR 53%, P = 0.072), nonvertebral (2.8% vs 6.1%; RRR 50%, P = 0.12), and all other fracture types evaluated. Rates of adverse events and positively adjudicated serious cardiovascular events were generally balanced between groups. Conclusions Efficacy and safety for romosozumab-to-denosumab were similar between Japanese women and the overall population. The sequence of romosozumab to rebuild the skeletal foundation before transitioning to antiresorptive treatment with denosumab is a promising regimen for Japanese postmenopausal women with osteoporosis at high risk of fracture. Electronic supplementary material The online version of this article (10.1007/s11657-019-0608-z) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Increased bone mineral density for 1 year of romosozumab, vs placebo, followed by 2 years of denosumab in the Japanese subgroup of the pivotal FRAME trial and extension

Miyauchi¹,

Dinavahi

Crittenden

et al. 2019

Arch Osteoporos

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“…In a recent clinical review on minodronate, Saeko Fujiwara et al [27] made a retrospective chart review. The most common OP medications prescribed initially were minodronic acid (20.1%), alendronate (19.9%), raloxifene (14.1%), weekly teriparatide acetate (12.4%), and eldecalcitol (11.4%).…”

Section: Discussionmentioning

confidence: 99%

Minodronate in the treatment of osteoporosis

Liu¹,

Chen²,

Ye³

et al. 2020

Medicine

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Background: The goal of this study was to review relevant randomized controlled trials or case-control studies to determine the clinical efficacy of minodronate in the treatment of osteoporosis. Method: The relevant studies were identified on PubMed, Cochrane, and Embase databases using appropriate keywords. Pertinent sources in the literature were also reviewed, and all articles published through October 2019 were considered for inclusion. For each study, we assessed odds ratios, mean difference, and 95% confidence interval (95% CI) to evaluate and synthesize outcomes. Result: Thirteen studies comprising 3740 patients were included in this study. Compared with other drugs, minodronate significantly decreased N-telopeptide of type I collagen/creatinine (weighted mean difference [WMD]: –13.669, 95% confidence interval [CI]: –23.108 to –4.229), bone alkaline phosphatase (BAP) (WMD: –1.26, 95% CI: –2.04 to –0.47) and tartrate-resistant acid phosphatase 5b (WMD: –154.11, 95% CI: –277.85 to –30.37). Minodronate combined with other drugs would significantly decrease BAP (WMD: –3.10, 95% CI: –5.20 to –1.00) than minodronate. Minodronate-naïve would significantly decrease BAP (WMD: –3.00, 95% CI: –5.47 to 0.53) and tartrate-resistant acid phosphatase 5b (WMD: –128.20, 95% CI: –198.11 to –58.29) than minodronate-switch. The incidence of vertebral fracture was significantly decreased in the minodronate group than the other drugs (relative risk: 0.520, 95% CI: 0.363–0.744). Conclusion: Minodronate has better clinical efficacy in the treatment of osteoporosis than other drugs (alendronate, risedronate, raloxifene, or eldecalcitol).

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“…OP is a global public health problem and affects appropriately 75 million people in the USA [ 3 ]. The ideal therapeutic goal is to increase the bone mass, and subsequently decrease the risk of fracture [ 4 ]. Bisphosphonates, a classic antiresorptive agent, is currently the most common therapy for osteoporosis [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

Denosumab compared to bisphosphonates to treat postmenopausal osteoporosis: a meta-analysis

Zhang

Yan

et al. 2018

J Orthop Surg Res

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BackgroundThe standard treatment for osteoporosis was controversial. Denosumab and bisphosphonates were two most common drugs. The purpose of this study was to compare the efficacy and safety of denosumab with bisphosphonates to treat osteoporosis.MethodsPublished literatures, only including randomized controlled trials (RCTs), were searched in the following electronic databases: PubMed, Embase, Web of Science, Cochrane Library, and Google database from inception to April 20 2018. Studies that compared denosumab with bisphosphonates to treat osteoporosis were included. Random-effect model was used for meta-analysis due to the unavoidable clinical heterogeneity. We used the risk of fracture as the primary outcome. Stata 12.0 was used for meta-analysis.ResultsEleven studies involving 5446 patients (denosumab = 2873, bisphosphonates = 2573) were included in the present meta-analysis. There was no significant difference between the risk of fracture (risk ratio (RR), 1.13; 95% confidence interval (CI), 0.82–1.55; P = 0.466), adverse events (AEs) (RR 1.00; 95% CI 0.96–1.04; P = 0.957) and withdrawn due to AEs (RR 0.68; 95% CI 0.34–137; P = 0.280). Denosumab compared with bisphosphonates significantly increased change in total hip, femoral neck, lumbar spine, and one-third radius bone mineral density (BMD) for postmenopausal osteoporosis patients (P < 0.05).ConclusionsOur meta-analysis suggested that denosumab but not bisphosphonates significantly increased change in total hip, femoral neck, lumbar spine, and one-third radius BMD for postmenopausal osteoporosis patients. Current evidence suggested no benefit of denosumab for reducing risk of fracture than bisphosphonates. More long-term follow-up RCTs are needed to identify the potential complications of denosumab.Electronic supplementary materialThe online version of this article (10.1186/s13018-018-0865-3) contains supplementary material, which is available to authorized users.

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Treatment patterns in patients with osteoporosis at high risk of fracture in Japan: retrospective chart review

Abstract: A high percentage of patients (87.9%) in Japan received OP medications soon after their high-risk diagnosis, with bisphosphonates, selective estrogen receptor modulators and teriparatide being the predominant treatment options.

Cited by 20 publications

References 15 publications

Increased bone mineral density for 1 year of romosozumab, vs placebo, followed by 2 years of denosumab in the Japanese subgroup of the pivotal FRAME trial and extension

Increased bone mineral density for 1 year of romosozumab, vs placebo, followed by 2 years of denosumab in the Japanese subgroup of the pivotal FRAME trial and extension

Minodronate in the treatment of osteoporosis

Denosumab compared to bisphosphonates to treat postmenopausal osteoporosis: a meta-analysis

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