Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB 
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  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Review, Journal:  Advancements in the Management of Fragility Fractures in Orthopaedic Patients. (Pubmed Central) -  Dec 23, 2024   
    Advancements in medical therapy include romosozumab, recommended by the National Institute for Health and Care Excellence guidance in patients with imminent fracture risk, which improves overall bone mineral density...The surgical approach to fragility fractures has undergone major advancements over the past 20 years, with developments such as polyaxial locking and far cortical locking systems that achieve secondary bone healing, as well as cement augmented screw fixation to provide stable fixation in osteoporotic bone. The development of minimally invasive surgical approaches has led to improved periosteal blood flow around a fracture site, as well as reduced operating time, hospital stay, and time to pain-free weight-bearing.
  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB, odanacatib (MK-0822) / Merck (MSD)
    Review, Journal:  The Management of Osteoporosis in Chronic Kidney Disease: A Review of Diagnostic and Therapeutic Approaches. (Pubmed Central) -  Dec 19, 2024   
    While traditional osteoporosis treatments such as bisphosphonates, denosumab, and teriparatide have been adapted for CKD patients, recent innovations have introduced agents aimed at enhancing bone mass and reducing fracture incidence...Osteoporosis management in CKD patients necessitates a personalized approach guided by the disease's stage and individual profile. This review underscores the potential of emerging therapies and emphasizes the need for further research to refine treatment protocols, aiming to enhance patient outcomes in this complex population.
  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Review, Journal:  Surgical Management of Adult Spinal Deformity Patients with Osteoporosis. (Pubmed Central) -  Dec 17, 2024   
    Specifically, expandable screws and cement augmentation have been shown to improve fixation stability. However, further research is needed to evaluate the effectiveness of these treatments, specifically in osteoporotic ASD patients.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Retrospective data, Journal:  Therapy with transitions from one bone-forming agent to another: a retrospective cohort study on teriparatide and romosozumab. (Pubmed Central) -  Nov 28, 2024   
    Furthermore, when examining the changes in the proportion of patients who achieved the osteoporosis treatment goal of a T-score exceeding -2.5, no significant increase was observed in the R2T group, whereas a significant increase was observed in the lumbar spine in the T2R group. Regarding therapy switching between bone-forming agents, this study suggests that transitioning from teriparatide to romosozumab increases BMD more effectively than transitioning in the opposite sequence.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Journal, HEOR, Cost-effectiveness, Cost effectiveness:  Cost-effectiveness intervention thresholds for romosozumab and teriparatide in the treatment of osteoporosis in the UK. (Pubmed Central) -  Nov 20, 2024   
    Regarding therapy switching between bone-forming agents, this study suggests that transitioning from teriparatide to romosozumab increases BMD more effectively than transitioning in the opposite sequence. The results of this study indicate that sequential romosozumab-to-alendronate or teriparatide-to-alendronate treatment can be a cost-effective treatment option for postmenopausal women at very high risk of fracture.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Enrollment closed:  A Study of Romosozumab (EVENITY (clinicaltrials.gov) -  Nov 17, 2024   
    P4,  N=100, Active, not recruiting, 
    Treatment with ROMO significantly increased lumbar spine BMD in GC-treated patients, suggesting that ROMO is effective for GIOP. Recruiting --> Active, not recruiting
  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Journal:  Treatment of glucocorticoid-induced osteoporosis with concurrent denosumab and romosozumab: a case report. (Pubmed Central) -  Oct 23, 2024   
    However, there is limited experience with the combination of denosumab and romosozumab, which may be an alternative antiresorptive/anabolic regimen for individuals who are not candidates for PTH receptor agonists. In this case, we present a young man with glucocorticoid-induced osteoporosis who could not tolerate a daily injectable anabolic and who experienced improvement in bone mineral density with concurrent denosumab and off-label romosozumab administration.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Clinical, Review, Journal:  A practical approach for anabolic treatment of bone fragility with romosozumab. (Pubmed Central) -  Oct 14, 2024   
    In this case, we present a young man with glucocorticoid-induced osteoporosis who could not tolerate a daily injectable anabolic and who experienced improvement in bone mineral density with concurrent denosumab and off-label romosozumab administration. Based on the available evidence, romosozumab could be proposed as ideal drug in several clinical settings, such as non-fractured post-menopausal women at very-high risk of fractures, patients with recent hip fracture, patients non responder to bisphosphonates and short-term denosumab therapy.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Enrollment closed:  A Study of Romosozumab in Women with Multiple Myeloma and Osteoporosis (clinicaltrials.gov) -  Oct 3, 2024   
    P1,  N=10, Active, not recruiting, 
    However, clinicians should consider the occurrence of minor AEs (e.g., injection-site reactions). Recruiting --> Active, not recruiting
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Review, Journal:  Extending the Therapeutic Potential: Romosozumab in Osteoporosis Management. (Pubmed Central) -  Oct 2, 2024   
    Adverse effects, comparative effectiveness with other osteoporotic agents, and challenges in sequential therapy are also discussed, providing insights for informed decision-making by physicians, particularly in the context of pre-treatment considerations. Additionally, the review examines global prescribing guidelines and highlights challenges associated with romosozumab utilization in special patient subgroups, aiming to optimize its clinical use.
  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Biomarker, Clinical, Retrospective data, Journal:  Comparison of Denosumab with Romosozumab in the treatment of male osteoporosis: a retrospective cohort study. (Pubmed Central) -  Oct 2, 2024   
    Conversely, with romosozumab, the levels of bone formation markers increased transiently at 6 months before returning to baseline, whereas bone resorption markers significantly decreased at both time points. Romosozumab demonstrated significantly superior effects over denosumab in improving BMD, especially of the lumbar spine, suggesting that romosozumab can be used for treating male osteoporosis.
  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Depressive Symptoms and RANKL/OPG in Hemodialysis (Exhibit Hall, Convention Center) -  Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_2018;    
    OPG wasn't significantly associated with depressive symptoms. Higher plasma RANKL levels were associated with lower depressive symptoms in HD patients.Odds ratios of plasma RANKL, OPG, and RANKL/OPG ratio for depressive symptoms OR (95% CI)UnadjustedP valueOR (95% CI)AdjustedP ValueRANKL tertile 1 Reference Reference RANKL tertile 20.51 (0.24-1.09)0.0800.42 (0.16-1.09)0.074RANKL tertile 30.40 (0.19-0.86)0.0180.31 (0.12-0.82)0.018OPG tertile 1Reference Reference OPG tertile 21.64 (0.78-3.44)0.1910.59 (0.20-1.69)0.326OPG tertile 31.37 (0.66-2.85)0.4010.29 (0.08-1.02)0.165RANKL/OPG tertile 1Reference Reference RANKL/OPG tertile 20.48 (0.23-1.03)0.0590.51 (0.20-1.32)0.041RANKL/OPG tertile 30.35 (0.17-0.75)0.0070.55 (0.21-1.42)0.256RANKL receptor activator of nuclear factor-?B ligand, OPG Osteoprotegerin, OR Odds Ratio, CI Confidential Interval Multivariate, adjusted for age, sex, BMI, Diabetes mellitus, cardiovascular diseases, HD vintage, spKt/V, hsCRP
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Enrollment open:  Combining bone-building medication with bone-building exercise in postmenopausal women with low bone mass (EUDRACT) -  Sep 20, 2024   
    P4,  N=102, Recruiting, 
    Higher plasma RANKL levels were associated with lower depressive symptoms in HD patients.Odds ratios of plasma RANKL, OPG, and RANKL/OPG ratio for depressive symptoms OR (95% CI)UnadjustedP valueOR (95% CI)AdjustedP ValueRANKL tertile 1 Reference Reference RANKL tertile 20.51 (0.24-1.09)0.0800.42 (0.16-1.09)0.074RANKL tertile 30.40 (0.19-0.86)0.0180.31 (0.12-0.82)0.018OPG tertile 1Reference Reference OPG tertile 21.64 (0.78-3.44)0.1910.59 (0.20-1.69)0.326OPG tertile 31.37 (0.66-2.85)0.4010.29 (0.08-1.02)0.165RANKL/OPG tertile 1Reference Reference RANKL/OPG tertile 20.48 (0.23-1.03)0.0590.51 (0.20-1.32)0.041RANKL/OPG tertile 30.35 (0.17-0.75)0.0070.55 (0.21-1.42)0.256RANKL receptor activator of nuclear factor-?B ligand, OPG Osteoprotegerin, OR Odds Ratio, CI Confidential Interval Multivariate, adjusted for age, sex, BMI, Diabetes mellitus, cardiovascular diseases, HD vintage, spKt/V, hsCRP Not yet recruiting --> Recruiting
  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB, Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
    ASSOCIATION OF MONOCLONAL ANTIBODY TREATMENT WITH THE DEVELOPMENT OF STRESS CARDIOMYOPATHY (Convention Center Exhibit Hall: Poster Area 1) -  Sep 11, 2024 - Abstract #CHEST2024CHEST_6320;    
    The FRAME study found similar incidence of cardiovascular events with romosozumab-denosumab compared to placebo-denosumab [1]...An analysis of the reSURFACE 1 and 2 trials found limited cardiovascular events with tildrakizumab, similar to placebo [3]... This case highlights a potential association between monoclonal antibodies and stress cardiomyopathy, however, the exact mechanism is uncertain emphasizing the need for further research.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    New P4 trial:  CAT: Combined Anabolic Therapy (clinicaltrials.gov) -  Aug 16, 2024   
    P4,  N=46, Not yet recruiting, 
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Trial completion date, Trial primary completion date:  A Study of Romosozumab in Women with Multiple Myeloma and Osteoporosis (clinicaltrials.gov) -  Aug 15, 2024   
    P1,  N=10, Recruiting, 
    Approaches that taper glucocorticoids and promote weight regain may be helpful in the management of such patients. Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Mar 2025 --> Mar 2026
  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Journal:  Role of sclerostin deletion in bisphosphonate-induced osteonecrosis of the jaw. (Pubmed Central) -  Aug 14, 2024   
    Enhanced bone formation and wound healing were observed in the tooth extraction socket. The use of romosozumab (anti-sclerostin antibody) has proven to be safe for surgical procedures of the jaw.
  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Review, Journal:  Recommendations for the optimal use of bone forming agents in osteoporosis. (Pubmed Central) -  Aug 9, 2024   
    This sequential treatment approach ensures sustained protection and optimal resource utilization. In summary, the effective use of bone forming agents in osteoporosis requires a comprehensive strategy that includes accurate patient identification, consideration of cost-effectiveness, and implementation of appropriate sequential treatments, ultimately maximizing patient outcomes and healthcare efficiency.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Journal, Surgery:  The potential effect of romosozumab on perioperative management for instrumentation surgery. (Pubmed Central) -  Aug 6, 2024   
    Romosozumab significantly increased the regional vBMD as well as biomechanical parameters, potentially offering clinical benefits in reducing post-operative complications in patients with osteoporosis undergoing orthopedic instrumentation surgery. This study highlights the novel advantages of romosozumab treatment and advocates further research on its effectiveness in perioperative management.