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Osteoporosis
Published in Jason Liebowitz, Philip Seo, David Hellmann, Michael Zeide, Clinical Innovation in Rheumatology, 2023
Mazen Nasrallah, Marcy B. Bolster
Impactful research themes over the last ten years have included investigations into the fundamental biology of bone (including exploring novel signaling pathways regulating bone formation and resorption, such as the Wnt pathway), the identification of novel druggable targets, including the use of monoclonal technologies (such as denosumab targeting RANK/RANKL pathway or romosozumab). Much research has evaluated the importance of optimizing balance between bone formation and resorption through identifying therapies with dual mechanisms of action (potentially romosozumab) versus investigating combination therapies. Other areas of research have included investigations focusing on identifying optimal duration of therapy to maximize therapeutic efficacy (of antiresorptive or anabolic therapies), implementation of the drug holiday, and safety considerations for treatment and drug holiday durations. Additionally, much effort has been invested in improving awareness of patients and providers to the societal impact of early identification of osteoporosis, early initiation of therapy, and addressing secondary fracture reduction.
The role of anabolic agents
Published in Peter V. Giannoudis, Thomas A. Einhorn, Surgical and Medical Treatment of Osteoporosis, 2020
Nifon K. Gkekas, Eustathios Kenanidis, Panagiotis Anagnostis, Michael Potoupnis, Dimitrios G. Goulis, Eleftherios Tsiridis
In two hallmark clinical studies (6,31), romosozumab was associated with a significant reduction of vertebral and clinical fractures at 12 and 24 months. However, the reduction in nonvertebral and hip fractures was noticed only when romosozumab and alendronate were evaluated together at 24 months (6). Patients randomized to romosozumab/alendronate achieved higher BMD values at all skeletal sites compared with alendronate alone (6). It must be emphasized that the discontinuation of romosozumab was followed by bone loss and the return of BMD to pretreatment levels, whereas the sequential administration of denosumab further increased BMD (32). Higher risk in severe adjudicated cardiovascular disease (CVD) events, however, was observed with romosozumab compared with alendronate (6). The exact pathogenetic mechanisms of this observation have not been elucidated, but these concerns have suspended romosozumab's approval by the FDA.
Precision medicine in osteoporosis and bone diseases
Published in Debmalya Barh, Precision Medicine in Cancers and Non-Communicable Diseases, 2018
Fatmanur Hacievliyagil Kazanci, Fatih Kazanci, M. Ramazan Yigitoglu, Mehmet Gunduz
The osteocytes inhibit bone formation by producing sclerostin (van Bezooijen et al., 2004). Romosozumab is an antisclerostin antibody that has been reported to stimulate bone formation as well as inhibit bone resorption (Chapurlat, 2016). However, the antifracture efficacy of this drug remains to be determined in ongoing trials.
A pharmacovigilance analysis of FDA adverse event reporting system events for romosozumab
Published in Expert Opinion on Drug Safety, 2023
Zepeng Chen, Ming Li, Shuzhen Li, Yuxi Li, Junyan Wu, Kaifeng Qiu, Xiaoxia Yu, Lin Huang, Guanghui Chen
Recently, many clinical studies have been made in the research of new drug treatment for osteoporosis. For example, dinosemide, teriparatide have been approved on the market for the treatment of different osteoporosis. However, both of them have their own advantages and disadvantages [16]. Romosozumab is a new drug that has been approved by the FDA for the treatment of osteoporosis in Phase III and Phase IV clinical trials [3]. As a new drug that has been on the market for about two year, the possible adverse reactions during its application have been partially collected in FAERS. However, no studies have been conducted to analyze the whole adverse reactions of these drugs from FAERS. In our study, we collected and analyzed the data of possible adverse reactions associated with romosozumab.
Romosozumab for the treatment of postmenopausal women at high risk of fracture
Published in Expert Opinion on Biological Therapy, 2023
Piet Geusens, Natasha Appelman-Dijkstra, Willem Lems, Joop van den Bergh
Romosozumab is new and unique osteoanabolic drug that simultaneously increases bone formation and decreases bone resorption. Compared to antiresorptive agents, this unique combination results in a more rapid and greater increase in BMD, and in repair and restoration of trabecular and cortical bone microarchitecture. Additionally, the reduction of fracture risk during treatment with romosozumab is more rapidly and more effectively than the AR alendronate, with persisting effects for at least two years after transition to AR agents. This finding has introduced the concept that in patients at very high risk of fractures may benefit from initial treatment with an osteoanabolic agent, followed by a potent AR agent, as recommended in recent national and international guidelines. It is therefore expected that romosozumab will be increasingly considered as first treatment when these guidelines are implemented, also in patients at the fracture liaison services with a recent fracture. Patients with a history of myocardial infarction or stroke should not be considered for treatment with romosozumab. Further data will be needed, such as long-term safety data, repeated use in patients with persisting or recurrent high fracture risk, and its effect on fractures in glucocorticoid users and in an ongoing study in pediatric patients with osteogenesis imperfecta [78].
The role of osteoanabolic agents in the management of patients with osteoporosis
Published in Postgraduate Medicine, 2022
Michael R. McClung, Micol S. Rothman, E. Michael Lewiecki, David A. Hanley, Steven T. Harris, Paul D. Miller, David L. Kendler
Romosozumab is a humanized monoclonal antibody that inhibits sclerostin, a natural inhibitor of bone formation, produced by osteocytes [13]. (Table 1) Romosozumab increases remodeling-based formation and also stimulates bone formation on trabecular and endocortical surfaces not undergoing remodeling (modeling-based formation) [22]. In contrast to teriparatide and abaloparatide, romosozumab inhibits RANK ligand, decreasing bone resorption [22,23]. Because the anabolic effect of romosozumab wanes over 12 months of treatment, therapy is limited to 12 monthly doses, with no lifetime exposure limit. Romosozumab is administered by a healthcare provider as two subcutaneous injections totaling 210 mg once monthly for 12 months.