The ability of denosumab to further suppress bone resorption in patients who were already receiving IV BPs indicates a mode of action different from bisphosphonates. Thus, de-escalation of denosumab, ZA and pamidronate treatment from 4- to 12-weekly is a reasonable treatment option in these patients . Lyu H, Jundi B, Xu C, Tedeschi SK, Yoshida K, Zhao S, Nigwekar SU, Leder BZ, Solomon DH. Seki K, Kaneko T, Kamimoto A, Wada M, Takeuchi Y, Furuchi M, Iinuma T. J Dent Sci. Impact of prevalent fractures on quality of life: baseline results from the global longitudinal study of osteoporosis in women. government site. Discussion: Effective pharmacotherapy is necessary for patients at high risk of fracture. Epub 2014 Mar 28. Figshare 2018. After completion, both authors met and reviewed their selections for agreement. Cummings SR, San Martin J, McClung MR, et al. There were some methodological limitations in some of the included trials, such as the inadequate concealment of treatment allocation. Antiresorptive drugs (e.g. Wang R, Zhang W, Ma H, Zou D, Zhang Z, Wang S. Front Mol Biosci. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. 1 As shown in Figure 1, A, the core structure of bisphosphonates differs only slightly from PPi in . As with bisphosphonates, treatment with . J Bone Metab. Papaioannou A, Joseph L, Ioannidis G, et al. Among the treatment options for postmenopausal osteoporosis, there are significant differences in mechanism and dosing. Pharmacologic Mechanisms of Therapeutics: Parathyroid Hormone. Unfortunately, many Canadian physicians do not routinely screen peri- and postmenopausal women for fracture history or assess patients 10-year fracture risk per OC Clinical Practice Guidelines, and they may be over-reliant on bone density measurements to assess risk (14,21). Activation of bone remodelling in a BMU therefore depends on the balance between RANKL and OPG. Role of RANK ligand and denosumab, a targeted RANK ligand inhibitor, in bone health and osteoporosis: a review of preclinical and clinical data. Five meta-analyses have compared denosumab and bisphosphonates in the treatment of osteoporosis (1317) and although current evidence suggests denosumab might increase BMD and reduce fracture risk more than bisphosphonates do, these results are not conclusive. Hussar DA, Stevenson T. New drugs: denosumab, dienogest/estradiol valerate, and polidocanol. Ohishi T, Fujita T, Nishida T, Hagiwara K, Murai R, Matsuyama Y. Osteoporos Sarcopenia. the display of certain parts of an article in other eReaders. Denosumab therapy did not demonstrate a significant difference in reducing the risk of (a) any type of fracture, (b) osteoporotic fracture at 12 mo, or (c) the risk of any type of, The Journal of Clinical Endocrinology and Metabolism. 5). Raloxifene inhibits bone loss and improves bone strength through an OPG-independent mechanism. Results: We identified 10 eligible trials including 5361 participants. GIO, glucocorticoid-induced osteoporosis. Before Gu HF, Gu LJ, Wu Y, Zhao XH, Zhang Q, Xu ZR, Yang YM. In patients who did not previously receive bisphosphonate treatment, lumbar spine BMD was increased with denosumab treatment more than it was with use of bisphosphonates (mean difference, 0.83%; 95% CI, 0.27% to 1.39%; P < 0.001). 2011 Jul;77(1):109-11. doi: 10.1016/j.mehy.2011.03.039. Key differences between and bisphosphonates and denosumab. People who take a bisphosphonate are less likely to break (fracture) a bone. An official website of the United States government. The Effects of Osteoporotic and Non-osteoporotic Medications on Fracture Risk and Bone Mineral Density. Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, Bauer DC, Genant HK, Haskell WL, Marcus R, Ott SM, Torner JC, Quandt SA, Reiss TF, Ensrud KE; Fracture Intervention Trial Research Group . In: Bilezikian JP, Raisz LG, Martin TJ, editors. Effects of hormone therapy on bone mineral density: results from the postmenopausal estrogen/progestin interventions (PEPI) trial. 2019 May; 104(5): 17531765. Download Citation | What is the risk of developing osteonecrosis following dental extractions for patients on denosumab for osteoporosis? Once-monthly ibandronate for postmenopausal osteoporosis: review of a new dosing regimen. For the continuous variable (i.e., percentage changes in BMD), weighted mean difference and 95% CIs were calculated. Osteoporosis is a chronic, progressive skeletal condition characterized by decreased bone mass and microarchitectural deterioration, leading to increased risk of fracture (1). A priori specified and exploratory subgroup analyses were performed to examine potential sources of heterogeneity and explore the reasons for inconsistent results between indirect and direct meta-analyses. Hip Intervention Program Study Group. This site needs JavaScript to work properly. Raloxifene mimics the effect of oestrogen in the bone, but it does not stimulate breast and uterine tissues (38). Bolland MJ, Grey AB, Gamble GD, Reid IR. Seeman E. Reduced bone formation and increased bone resorption: rational targets for the treatment of osteoporosis. Kendler DL, McClung MR, Freemantle N, Lillestol M, Moffett AH, Borenstein J, Satram-Hoang S, Yang YC, Kaur P, Macarios D, Siddhanti S; DAPS Investigators . As there is only one RCT demonstrating greater osteoporotic fracture reduction using denosumab (28), future longitudinal studies with longer follow-up and large sample size are needed to confirm the efficacy difference. All have reviewed and approved the final submission. Kanis JA, Johansson H, Oden A, McCloskey EV. The literature search was performed independently by two authors (H.L., B.J.). Results: A total of 2850 randomized patients (1424 bisphosphonate:1426 denosumab) were included in the analysis. On the other hand, bisphosphonates have a persistent but not progressive antiresorptive effect; bisphosphonate treatment results in increased BMD over the first few years, but then change in BMD plateaus (35). Superiority testing demonstrated the BMD increase with denosumab at the total hip was statistically superior to the change with alendronate ( p < 0.0001) 1. The incidences of adverse events were similar between treatment groups. We conducted a patient-level pooled analysis of four studies to estimate the efficacy and safety of transitioning to denosumab vs. continuing bisphosphonate treatment in postmenopausal women who previously received oral bisphosphonates. Assessment of fracture risk. Clin Ther. Characterised by reduced bone mineral density (BMD) and weakened bone structure (2,3,68), osteoporosis decreases bone resistance to low-energy trauma and increases bone fragility and fracture risk (6,8,9). Bone density and markers of bone turnover in predicting fracture risk and how changes in these measures predict fracture risk reduction, Therapy of endocrine disease: denosumab vs bisphosphonates for the treatment of postmenopausal osteoporosis. 2006 Apr;28(4):475-90. doi: 10.1016/j.clinthera.2006.04.006. Reprinted from Denosumab: Mechanism of action and clinical outcomes, 43, 2, Paul D. Miller, Michael A. Bolognese, E. Michael Lewiecki, Michael R. McClung, Beiying Ding, Matthew Austin, Yu Liu, Javier San Martin, for the AMG 162 Bone Loss Study Group, 222229., 2008, with permission from Elsevier. You may switch to Article in classic view. There is also significant recycling of bisphosphonates in bone, resulting in retention of measurable amounts for several years (35). J Clin Endocrinol Metab. Ontarios strategy paves the way for better care across Canada. Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: efficacy and safety results from a randomized open-label study. 2022 Jan;39(1):58-74. doi: 10.1007/s12325-021-01936-y. Osteocytes, osteoblasts and osteoclasts are the main cells of the BMU of remodelling bone. Denosumab has a fundamentally different mechanism of action from that of bisphosphonates. Our study provides moderately strong evidence (41) that denosumab is more effective in increasing BMD at lumbar spine, total hip, and femoral neck than are bisphosphonates at 12 and 24 months. Clipboard, Search History, and several other advanced features are temporarily unavailable. Lyu H, Jundi B, Xu C, Tedeschi SK, Yoshida K, Zhao S, Nigwekar SU, Leder BZ, Solomon DH. Trials that did not meet the eligibility criteria were excluded. D A Hanley, J D Adachi, [], and V Brown. Denosumab binds the cytokine RANKL, preventing it from binding its receptor, RANK. Summary 1070. Osteoporotic fractures account for approximately 80% of all fractures occurring in postmenopausal women (14). Clinicians guide to prevention and treatment of osteoporosis. BMUs like the one depicted here occur by the millions throughout the skeleton. Denosumab compared to other treatments to prevent or treat osteoporosis in individuals at risk of fracture: a systematic review and meta-analysis. Understanding the bone remodelling pathways may be helpful in selecting appropriate treatment for patients and will be essential as new therapies continue to be introduced. But the inconsistent results between indirect and direct meta-analyses deserve further clarification. Cummings SR, Black DM, Thompson DE, Applegate WB, Barrett-Connor E, Musliner TA, Palermo L, Prineas R, Rubin SM, Scott JC, Vogt T, Wallace R, Yates AJ, LaCroix AZ. Bone loss and structural damage occur when the extent of bone resorption within a BMU exceeds that of bone formation (negative bone balance) (24). Three patients (one bisphosphonate and two denosumab) had atypical femoral fractures, all from the denosumab vs. zoledronic acid study. Second, exploratory subgroup analysis was performed by grouping studies into those including patients who previously received bisphosphonate therapy vs those including patients who did not receive bisphosphonate therapy. 10.6084/m9.figshare.7406543. Two trials did not clearly report the random sequence generation (29, 31). PMC Disclosure Summary: H.L. Other risk factors for ONJ include cancer, radiotherapy, poor oral hygiene, pre-existing dental disease or infection, anemia, and coagulopathy. Denosumab and bisphosphonates: rivals or potential "partners"? Risk ratio of (a) any, MeSH First, evidence of long-term BMD benefit of denosumab compared with bisphosphonates was very limited. Clinical Practice Guidelines for the Diagnosis and Management of Osteoporosis in Canada: Background and Technical Report. The association between BMD increase and fracture risk reduction related to use of antiresorptive agents is very important for osteoporosis treatment initiation and monitoring. Effect of parathyroid hormone (134) on fractures and bone mineral density in postmenopausal women with osteoporosis. Six of the 10 studies (9, 25, 26, 28, 32, 33) compared the efficacy of denosumab with alendronate, two studies (30, 31) compared denosumab with zoledronic acid, one study compared denosumab with ibandronate (27) and one study compared denosumab with risedronate (29). Denosumab compared with ibandronate in postmenopausal women previously treated with bisphosphonate therapy: a randomized open-label trial. Effect of osteoporosis treatment on mortality: a meta-analysis. Neer RM, Arnaud CD, Zanchetta JR, et al. Would you like email updates of new search results? . Osteocytes, osteoblasts and osteoclasts are the main cells of the BMU of remodelling bone. Niimi R, Kono T, Nishihara A, Hasegawa M, Kono T, Sudo A. Efficacy of switching from teriparatide to bisphosphonate or denosumab: a prospective, randomized, open-label trial. Brown JP, Josse RG. Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation. Some bisphosphonates available for treatment in India are listed in Denosumab is a human monoclonal antibody that binds with and inhibits cytokine RANKL. 2022 Oct 1;17(1):131. doi: 10.1007/s11657-022-01166-x. Keywords: Since 2014, five more pivotal head-to-head trials have been published. However, several limitations should also be noted. Although these numbers appear small, such differences would translate into clinically important fracture differences if observed in large-enough populations. Oestrogen, used alone, can reduce the incidence of vertebral and hip fractures (10). official website and that any information you provide is encrypted Osteoporosis Society of Canada. Based on data from 2000 to 2005, it is estimated that more than 138,000 such fractures occur annually in Canada (15). Osteoporos Int. In addition, the mean difference at total hip and femoral neck also increased. The bisphosphonates included alendronate, ibandronate, risedronate, and zoledronic acid. This site needs JavaScript to work properly. Despite a range of dosing frequencies and administration routes, the Guidelines cite consistent evidence from randomized clinical trials, suggesting that currently available treatments reduce vertebral fracture risk in postmenopausal women with osteoporosis (14). 10.6084/m9.figshare.7406585. eCollection 2022. This topic review provides an overview of the pharmacology of the bisphosphonates and of the differences between the preparations that are either currently available or undergoing clinical testing. 2012 Mar;34(3):521-36. doi: 10.1016/j.clinthera.2012.02.002. Clearance of bisphosphonates from the circulation is via renal excretion or adsorption to bone mineral. The https:// ensures that you are connecting to the In this meta-analysis of head-to-head randomized control trials (RCTs), we aimed to determine whether denosumab is more effective than bisphosphonates in increasing bone mass and reducing fracture risk in patients with low BMD or osteoporosis. the prevention of these complications uses Bisphosphonates (BP). It is uncertain which osteoporosis therapy is more effective: bisphosphonates or denosumab. Kendler DL, Roux C, Benhamou CL, Brown JP, Lillestol M, Siddhanti S, Man HS, San Martin J, Bone HG. Everts-Graber J, Bonel H, Lehmann D, Gahl B, Huselmann H, Studer U, Ziswiler HR, Reichenbach S, Lehmann T. JBMR Plus. The mean and SD, SE, and CI of percentage changes of BMD were extracted for calculation. Conclusion: Longitudinal studies with longer follow-up and large sample size are needed to confirm the efficacy difference. In addition to the bisphosphonates, raloxifene is also effective in preventing vertebral fractures (14,36,37). Bone HG, Bolognese MA, Yuen CK, et al. A variety of therapeutic approaches fall under the general category of antiresorptive treatment. The continuing increase in bone density with prolonged therapy raises the possibility of increases in bone strength and enhanced fracture prevention. Lipton A, Goessl C. Clinical development of anti-RANKL therapies for treatment and prevention of bone metastasis. Int J Clin Pract. rash and pruritus, were reported in more women receiving denosumab than placebo (12.0% vs 9.1%, RR 1.8, 95% CI 1.34 to 2.36) in . Fractures carry a substantial burden of morbidity and mortality, but are preventable by pharmacotherapy in high-risk patients. Objective: Epub 2016 Jun 6. Studies are needed to address these knowledge gaps. The better performance of denosumab relative to that of bisphosphonates in increasing BMD was found in treatment-nave patients and patients who previously had received bisphosphonate treatment. BMUs like the one depicted here occur by the millions throughout the skeleton. 2016 Oct 5;10(10):CD001347. Medication-related osteonecrosis of the jaw after tooth extraction in patients receiving pharmaceutical treatment for osteoporosis: A retrospective cohort study. HHS Vulnerability Disclosure, Help The Writing Group for the PEPI. Denosumab improved BMD significantly more than bisphosphonate treatment at the lumbar spine, total hip, and femoral neck at 12 and 24 months. At 24 months, the respective increase differences were 1.74% (95% CI, 1.05% to 2.43%; P < 0.001), 1.22% (95% CI, 0.66% to 1.77%; P < 0.001), and 1.19% (95% CI, 0.65% to 1.72%; P < 0.001). These biochemical differences may affect the clearance of the bisphosphonate, both immediately after dosing and in the longer term, when bone-associated drug is released by osteoclast action. A decrease of bone formation is then observed secondarily Roelofs, A.J., et al., Molecular mechanisms of action of bisphosphonates: current status. The doses of bisphosphonates were alendronate 70 mg once weekly, ibandronate 150 mg once monthly, risedronate 150 mg once monthly, and zoledronic acid 5-mg infusion once yearly, except one study in which alendronate 35 mg once weekly was used (9.4%; 242 of 2562) (28). Denosumab impairs the development, activation, and survival of osteoclasts, thus inhibiting bone resorption (6). Denosumab is the newest of the first-line osteoporosis treatments and is distinguished from other antiresorptives by its novel mechanism of action and its twice-yearly dosing. OC Clinical Practice Guidelines identify denosumab as a first-line option for preventing vertebral, hip and non-vertebral fractures (3,14). Briefly, denosumab is a fully human monoclonal antibody that inhibits RANKL and helps regulate turnover in healthy bone. already built in. Bisphosphonates: from the laboratory to the clinic and back again. With reduced RANKRANKL binding, osteoclast formation, function and survival are inhibited, bone resorption decreases and bone mass increases (1113). Skeletal uptake is more efficient for zoledronic acid, relative to the others. As shown in Table 1, there are some differences among them regarding dose and administration. already built in. The clinical and economic burden of non-adherence with oral bisphosphonates in osteoporotic patients. A difference of 1.42% at the lumbar spine may not be associated with clinically significant reduction in fracture risk. 2022 Apr 4;37(13):e68. Thus, differences in bone affinity can influence the required dosing of the bisphosphonates and the reversibility of their effects (34). contributed equally to this study. J Bone Miner Res. Denosumab is the first RANKL inhibitor to be approved by the FDA. The current meta-analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (18, 19). Dore RK. Denosumab: mechanism of action and clinical outcomes, Re-use of this article is permitted in accordance with the Terms and Conditions set out at. A previous network meta-analysis (14) reported that denosumab was more effective than bisphosphonates in preventing new vertebral fractures (RR, 0.62; 95% CI, 0.44 to 0.87) but not in preventing nonvertebral fracture, hip fracture, or wrist fracture. 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