Prolia (denosumab) / Amgen 
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  • ||||||||||  Prolia (denosumab) / Amgen
    Review, Journal:  Proceedings of the 2024 Santa Fe Bone Symposium: Update on the Management of Osteoporosis and Rare Bone Diseases. (Pubmed Central) -  Jan 30, 2025   
    Topics included an update on clinical uses of osteoanabolic agents, management of patients discontinuing denosumab, bone health optimization for orthopedic surgery, estrogen and testosterone in the management of osteoporosis, osteoporosis treatment in the very old, overview of rare bone diseases, treat-to-target for osteoporosis, and a progress report on global activities of Bone Health ECHO...Ancillary events addressed modern approaches to menopause and bone health, case studies of management of patients at very high fracture risk, and management of patients with rare bone diseases, such as hypophosphatasia, fibrodysplasia ossificans progressiva, X-linked hypophosphatemia, and hypoparathyroidism. These proceedings of the SFBS present the clinical highlights of the plenary sessions and the discussions that followed.
  • ||||||||||  Prolia (denosumab) / Amgen
    Journal:  Impact of glucocorticoids on the therapeutic efficacy of denosumab against osteoporosis in patients with rheumatoid arthritis. (Pubmed Central) -  Jan 30, 2025   
    Similarly, in patients with anti-cyclic citrullinated peptide (CCP) antibody positivity or those treated with biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs), although there were significant increases in the T-score and areal BMD at all sites in both groups, there were no significant between-group differences. Our findings suggest that the GC dose considered to increase the risk of GIOP did not significantly attenuate the therapeutic efficacy of denosumab in RA patients, including those positive for anti-CCP antibodies and users of biologic or targeted synthetic DMARDs.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion date, Trial primary completion date:  DEnosumab for the Treatment of FIbrous Dysplasia/McCune-Albright Syndrome in Adults (DeFiD) (clinicaltrials.gov) -  Jan 29, 2025   
    P4,  N=82, Recruiting, 
    Our findings suggest that the GC dose considered to increase the risk of GIOP did not significantly attenuate the therapeutic efficacy of denosumab in RA patients, including those positive for anti-CCP antibodies and users of biologic or targeted synthetic DMARDs. Trial completion date: Jun 2025 --> Dec 2028 | Trial primary completion date: Dec 2024 --> Dec 2027
  • ||||||||||  Xofigo (radium Ra-223 dichloride) / Bayer
    Review, Journal:  Role of osteoclast inhibitors in prostate cancer bone metastasis; a narrative review. (Pubmed Central) -  Jan 27, 2025   
    To reduce MRONJ in patients with cancer, face-to-face consultations with pharmacists could serve as a valuable opportunity to inform patients about MRONJ and encourage regular dental visits. Osteoclast inhibitors are effective in reducing skeletal related events in advanced bone metastasis and improve the quality of life of patients.
  • ||||||||||  Prolia (denosumab) / Amgen
    Review, Journal:  Osteoporosis in Older Men: Informing Patient Management and Improving Health-Related Outcomes. (Pubmed Central) -  Jan 18, 2025   
    Most older men with osteoporosis should be treated with oral or intravenous bisphosphonates, denosumab especially when on androgen deprivation therapy, and initial anabolic treatment should be considered for men at very high risk of fracture. This review summarizes the main features of osteoporosis and fragility fractures in men and reports findings from the available pharmacological and non-pharmacological studies conducted in men.
  • ||||||||||  Prolia (denosumab) / Amgen
    Journal:  Long-Term Efficacy and Safety of Denosumab: Insights beyond 10 Years of Use. (Pubmed Central) -  Jan 13, 2025   
    In certain scenarios, such as advanced chronic kidney disease, prolonged denosumab may be required to balance AE risks with fracture prevention benefits. Denosumab shows potential for long-term efficacy in augmenting BMD; however, monitoring for AEs is crucial to guide clinical decision-making effectively.
  • ||||||||||  Prolia (denosumab) / Amgen
    Journal:  Does early administration of denosumab delay bone healing after intertrochanteric femoral fractures? (Pubmed Central) -  Jan 12, 2025   
    Denosumab shows potential for long-term efficacy in augmenting BMD; however, monitoring for AEs is crucial to guide clinical decision-making effectively. Early administration of denosumab after intertrochanteric femoral fracture surgery did not delay radiological or clinical fracture healing times when compared with ibandronate administration.
  • ||||||||||  Prolia (denosumab) / Amgen
    Retrospective data, Review, Journal:  Anti-osteoporotic drug efficacy for periprosthetic bone loss after total hip arthroplasty: A systematic review and network meta-analysis. (Pubmed Central) -  Jan 12, 2025   
    Early administration of denosumab after intertrochanteric femoral fracture surgery did not delay radiological or clinical fracture healing times when compared with ibandronate administration. Bisphosphonate and denosumab may be effective anti-osteoporotic drugs for preventing periprosthetic proximal femoral bone loss due to stress shielding after THA, particularly in cementless proximal fixation stems, which are the most commonly used prostheses worldwide.
  • ||||||||||  Prolia (denosumab) / Amgen
    Review, Journal:  Current and emerging bone resorption inhibitors for the treatment of osteoporosis. (Pubmed Central) -  Jan 12, 2025   
    Critical pathways and key molecules that mediate regulation of bone resorption have been identified. These factors may underpin novel therapeutic avenues for osteoporosis, but their potential for translation into clinical applications is yet to be tested.
  • ||||||||||  Prolia (denosumab) / Amgen
    Journal:  The Effect of Denosumab on Pain and Radiological Improvement in Giant Cell Tumours of the Spine in the Acute Setting. (Pubmed Central) -  Jan 12, 2025   
    This study provides necessary insight to the limited literature on the use of denosumab for spinal GCT in the acute phase. The clinical and radiographic responses observed demonstrate the critical role that neo-adjuvant denosumab has by reducing the tumour burden around critical adjacent neurovascular structures before eventual resection, significant pain improvement even with presence of fractured vertebra.
  • ||||||||||  Prolia (denosumab) / Amgen, Orkedia (evocalcet) / Mitsubishi Tanabe
    Journal:  Severe hypophosphataemia following denosumab administration successfully managed using a calcimimetic agent. (Pubmed Central) -  Jan 12, 2025   
    Evocalcet contributed to the normalised parathyroid hormone and phosphorus levels, allowing the discontinuation of phosphorus supplementation. This case highlights the complexity of managing electrolyte imbalances induced by bone-modifying agents, such as denosumab, underscoring the importance of monitoring bone metabolism markers and the potential effectiveness of evocalcet in managing drug-induced secondary hyperparathyroidism and hypophosphataemia.
  • ||||||||||  Prolia (denosumab) / Amgen, zoledronic acid / Generic mfg.
    Journal:  Clinical experience with denosumab discontinuation. (Pubmed Central) -  Jan 12, 2025   
    Adhering to the recommendation in the ECTS position statement, a mean of 3 infusions of ZOL limited the bone loss 12 and 24 months after DMAb discontinuation, thereby preserving most of the BMD gained during DMAb treatment. The frequent occurrence of flu-like symptoms after ZOL proves to be a challenge, showing that routine prophylaxis against acute phase responses should be considered in patients treated with ZOL after discontinuing DMAb.
  • ||||||||||  Prolia (denosumab) / Amgen
    Clinical data, Retrospective data, Journal:  Denosumab and clinical outcomes among men with osteoporosis: a retrospective cohort study. (Pubmed Central) -  Jan 12, 2025   
    The frequent occurrence of flu-like symptoms after ZOL proves to be a challenge, showing that routine prophylaxis against acute phase responses should be considered in patients treated with ZOL after discontinuing DMAb. In this large, real-world study evaluating denosumab treatment among men with osteoporosis, the observed fracture risk reductions were consistent with the available risk reductions demonstrated in clinical trials among women with postmenopausal osteoporosis.
  • ||||||||||  Prolia (denosumab) / Amgen
    Journal, Adverse events, Real-world evidence, Real-world:  Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) Database. (Pubmed Central) -  Jan 8, 2025   
    In this large, real-world study evaluating denosumab treatment among men with osteoporosis, the observed fracture risk reductions were consistent with the available risk reductions demonstrated in clinical trials among women with postmenopausal osteoporosis. This pharmacovigilance database analysis indicates a high safety signal for hypocalcemia associated with denosumab, particularly in cancer patients.
  • ||||||||||  Prolia (denosumab) / Amgen
    Clinical, Journal:  Possible role of bone turnover markers in the diagnosis of adult hypophosphatasia. (Pubmed Central) -  Jan 6, 2025   
    In this multicenter study, we enrolled 23 adult patients with a diagnosis of HPP and compared them with 46 osteoporotic subjects previously treated with zoledronic acid or denosumab. Similar results were confirmed when including male HPP patients, when adjusting for age and sex, and finally when performing a sensitivity analysis only in patients with ALP less than or equal to 32
  • ||||||||||  Prolia (denosumab) / Amgen
    Assessment Of Clinical Approaches To Bone Health And Quality Of Life After Treatment In An Italian Cohort Of Breast Cancer Survivors (Exhibition hall) -  Jan 4, 2025 - Abstract #ESGO2025ESGO_1737;    
    At enrolment, only 7.7% of patients received antiresorptive therapy, increasing to 48.3% post-intervention, with Denosumab as the leading treatment...Despite guidelines, there is a lack of coordinated care, resulting in delayed osteoporosis interventions as well as diverse treatment approaches. A dedicated bone health pathway within post-menopausal BC survivors' oncological care is required to improve patient outcomes and QoL.
  • ||||||||||  Prolia (denosumab) / Amgen
    Journal:  Progress in the treatment of giant cell tumors of extremities with pathological fracture (Pubmed Central) -  Jan 3, 2025   
    RANKL inhibitors such as denosumab may be recommended if surgery is not possible or before performing resection. This article summarizes the common treatment modalities of pathological fractures combined with giant cell tumors of extremities, including the current status of surgical and pharmacological treatments, analyzing the choice of surgical modalities in different clinical situations, in order to provide clinical inspirations for diagnosis and treatment.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion:  A Study of Denosumab in Multiple Myeloma Patients with Renal Insufficiency (clinicaltrials.gov) -  Jan 3, 2025   
    P2,  N=55, Completed, 
    This article summarizes the common treatment modalities of pathological fractures combined with giant cell tumors of extremities, including the current status of surgical and pharmacological treatments, analyzing the choice of surgical modalities in different clinical situations, in order to provide clinical inspirations for diagnosis and treatment. Recruiting --> Completed
  • ||||||||||  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.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion date, Trial primary completion date:  OsteoNAFLD: Effect of Anti-osteoporotic Medications on Nonalcoholic Fatty Liver Disease (clinicaltrials.gov) -  Dec 16, 2024   
    P4,  N=70, Recruiting, 
    However, real-world data also suggest an OS benefit when bone-modifying agents are used, even after controlling for possible confounding patient and tumor characteristics. Trial completion date: Dec 2025 --> Sep 2026 | Trial primary completion date: Dec 2024 --> Sep 2025
  • ||||||||||  Prolia (denosumab) / Amgen
    Review, Journal:  Management of Medication-Related Osteonecrosis of the Jaw: An Overview of National and International Guidelines. (Pubmed Central) -  Dec 13, 2024   
    There is disparity on strategies to reduce the risk of osteonecrosis such as the avoidance of invasive dental procedures, therapy suspension, and techniques to reduce the impact of invasive surgery. The authors recommend an international lead in the development of dental guidelines to establish a global standardised management approach aiming for better health equality.