Prolia (denosumab) / Amgen 
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 110 Diseases   151 Trials   151 Trials   7120 News 


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  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Preclinical, Review, Journal:  Preclinical Models of Medication-related Osteonecrosis of the Jaw (MRONJ). (Pubmed Central) -  Oct 28, 2021   
    The course of MRONJ, including stage 0 MRONJ, is characterized well enough that basic studies of the molecular or enzyme-level findings in different MRONJ stages are possible. This review provides a current overview of the existing models of MRONJ, their more significant features and findings, and important instances of their application in preclinical research.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Acute leg compartment syndrome after CT-guided core needle biopsy of a giant cell tumor of the proximal fibula. (Pubmed Central) -  Oct 27, 2021   
    Pathologic analysis confirmed the diagnosis of GCT, which was resected after neoadjuvant denosumab therapy...ACS is not a well-known complication of CNB in the diagnosis of bone tumors. This rare complication might be diagnosed too late, or even missed, due to pre-existing pain, which can sometimes be severe in GCT, and to the usually short post-procedure surveillance in an outpatient procedure.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Clinical data, Journal:  Clinical outcome of a conservative approach to giant cell tumor of ankle and foot bones. (Pubmed Central) -  Oct 27, 2021   
    One patient with multifocal disease was treated conservatively with denosumab...GCTB affecting the foot and ankle have a clinical course comparable to those at other locations. They should be treated with a conservative approach, where radical resection and amputation are reserved for only the non-curettable tumors.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Seasonal Variation and Global Public Interest in the Internet Searches for Osteoporosis. (Pubmed Central) -  Oct 27, 2021   
    Further studies aimed at elucidating the possible mechanisms behind seasonality in osteoporosis are needed. Moreover, Internet data including the top rising topics may alert physicians to strengthen the propaganda of osteoporosis timely, so as to further promote the development of public health interventions.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Preclinical, Journal:  Engineered Osteoclasts Resorb Necrotic Alveolar Bone in Anti-RANKL Antibody-Treated Mice. (Pubmed Central) -  Oct 27, 2021   
    Medication-related osteonecrosis of the jaw (MRONJ) is a serious side effect of antiresorptive medications such as denosumab (humanized anti-RANKL antibody), yet its pathophysiology remains elusive...Sockets treated with iRANK cells + CID had significantly more osteoclasts and less necrotic bone than those receiving iRANK cells alone. These data support the hypothesis that osteoclast deficiency leads to accumulation of necrotic bone in MRONJ.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Cell Biology of Giant Cell Tumour of Bone: Crosstalk between m/wt Nucleosome H3.3, Telomeres and Osteoclastogenesis. (Pubmed Central) -  Oct 25, 2021   
    Denosumab was recently introduced as an extra option of medical treatment next to traditional surgical and in rare cases, radiotherapy...This review summarises the recent relevant literature of histone H3.3 in relation to the GCTB-specific G34W mutation and pays specific attention to the G34W mutation in relation to the development of TAs, genomic instability, and the characteristic morphology of GCTB. As pieces of an etiogenetic puzzle, this review tries fitting all these molecular features and the unique H3.3 G34W mutation together in GCTB.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Cancer Patients at Risk for Medication-Related Osteonecrosis of the Jaw. A Case and Control Study Analyzing Predictors of MRONJ Onset. (Pubmed Central) -  Oct 25, 2021   
    The multiple logistic regression model showed that breast, multiple myeloma, and prostate cancer involved a significantly higher risk compared to lung cancer; a significant effect of the combined variables number of doses of zoledronic acid and/or denosumab (OR = 1.03; 95% CI = 1.01-1.06); p-value = 0.03) and exposure to novel molecule treatment (OR = 34.74; 95% CI = 1.39-868.11; p-value = 0.03) was observed. The results suggest that a risk assessment paradigm is needed for personalized prevention strategies in the light of patient-centered care.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Review, Journal:  Effect of cytotoxic chemotherapy on bone health among breast cancer patients. Does it require intervention? (Pubmed Central) -  Oct 20, 2021   
    No cost-effectiveness analysis has yet been performed for denosumab and zoledronic acid on patients with metastatic lung cancer, and this represents an avenue for future research. This review summarizes the negative effect of chemotherapy on bone health of BC patients and the importance of preventing or treating bone loss.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
    [VIRTUAL] Recurrent Renal Cell Carcinoma Post Renal Transplantation () -  Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_1376;    
    Immunosuppression(IS) included Mycophenolate Mofetil (MMF), Tacrolimus (FK), and steroids (S)...1 year later, he developed BK viremia, and IS was changed to Everolimus and S. 2 years post-Tx, RCC metastasis was detected only in the pancreas head and tail...IS involved MMF, Cyclosporine, and S. History was significant for L nephrectomy 3 years pre-Tx for RCC...Treatment involved change in IS to Sirolimus and Azathioprine...His current treatment involves TKI with Denosumab, and he still has a functioning allograft...We suspect that recurrent disease arises from micrometastatic tumor cells that escape immune surveillance. RTR with a history of RCC prior to Tx should be monitored closely for metastatic recurrence post Tx.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    [VIRTUAL] The Incidence of Hypocalcemia After Denosumab Administration in Patients with CKD () -  Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_1340;    
    Our study emphasizes the importance of awareness of denosumab-induced hypocalcemia, routine monitoring post-denosumab, and benefit-risk assessment before prescribing this treatment to patients with kidney disease. The cumulative incidence of mild hypocalcemia (Ca <2.00 mmol/L) at 180 days
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    [VIRTUAL] The Efficacy and Safety of Denosumab for Osteoporosis in Advanced CKD with or Without Dialysis () -  Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_1338;    
    Conclusion Denosumab significantly increased BMD and was safe in advanced CKD patients with osteoporosis. Although severe hypocalcemia or other severe adverse outcomes were rare, physicians should keep in mind that the patients essentially need adequate vitamin D and calcium replacement prior to administration of denosumab.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    [VIRTUAL] Holy Fanconi, My Bone Is Breaking! () -  Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_1315;    
    The patient’s hepatologist switched TDF to tenofovir alafenamide (TAF) given the requirement for lifelong hepatitis B therapy...Other forms of tenofovir nephrotoxicity include ATN, chronic interstitial nephritis and nephrogenic diabetes insipidus. Figure: Case presentation of tenofovir-induced Fanconi syndrome.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Victoza (liraglutide) / Novo Nordisk
    [VIRTUAL] Liraglutide-Induced Hypercalcemia with AKI () -  Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_933;    
    We suggest close monitoring and potential reduction of Calcitriol and CaCO3 dose prior to starting gastroparetic agents like Liraglutide. Further studies are recommended to better elucidate the pharmacokinetics of Calcitriol and Liraglutide.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  A cautionary case: osteoporotic femur fracture after robotic-assisted total knee arthroplasty. (Pubmed Central) -  Oct 16, 2021   
    This is a unique complication related to the use of robotics which requires additional skeletal fixation versus standard arthroplasty surgical technique. We recommend caution and further study regarding the use of robotics in total knee arthroplasty in the setting of osteoporosis and denosumab use.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion date, Trial primary completion date:  Study of XGEVA (clinicaltrials.gov) -  Oct 14, 2021   
    P4,  N=35, Not yet recruiting, 
    We recommend caution and further study regarding the use of robotics in total knee arthroplasty in the setting of osteoporosis and denosumab use. Trial completion date: Nov 2025 --> Oct 2026 | Trial primary completion date: Nov 2025 --> Oct 2026
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Retrospective data, Review, Journal:  Meta-analysis of clinical trials to assess denosumab over zoledronic acid in bone metastasis. (Pubmed Central) -  Oct 13, 2021   
    Conclusion Overall, denosumab showed superiority in delaying the first and subsequent SREs, and hence seems to be a promising choice for managing bone metastases in both solid tumors and MM. However, it can induce a higher incidence of ONJ and hypocalcaemia, but these are preventable and manageable effects.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Which is the best antiresorptive treatment after finishing teriparatide? (Pubmed Central) -  Oct 12, 2021   
    We conclude that both antiresortive treatments have a similar effect in biochemical markers after one year of treatment. BMD increase significantly in total hip and changed with a trend toward in lumbar spine with denosumab, but without differences between both groups of treatment.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal, Adverse events:  Denosumab as a treatment for giant cell tumor of bone. Indications, results and side effects (Pubmed Central) -  Oct 12, 2021   
    A local recurrence was evidenced in 6 of 14 patients, and at least one adverse effect related to denosumab (including tumor malignancy) was identified in 7. Despite being a useful tool for treating giant cell tumor, the use of denosumab is associated with a higher rate of local recurrences and is not free of adverse effects.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Multiple Vertebral Fractures Following Discontinuation Of Denosumab Treatment: Ten Clinical Cases Report. (Pubmed Central) -  Oct 8, 2021   
    This will be the first RCT providing level one evidence regarding the optimal frequency of BMA treatment that accounts for health-related quality of life after ≥ two years of prior BMA in this patient population. This report of ten new cases suffering multiple vertebral fractures early after discontinuation of DMab highlights the emerging concern on the subject in the scientific community and the need to clarify its pathogenic mechanism, and to support by solid evidence the new recommendations on its management.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Immobilization-induced hypercalcemia in a patient with renal failure. (Pubmed Central) -  Oct 7, 2021   
    Extensive workup of common etiologies of hypercalcemia should be considered prior to arriving at this diagnosis. Denosumab, while off-label for this usage, offers an effective treatment option for immobilization-induced hypercalcemia though it carries a risk of hypocalcemia especially among patients with renal disease.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Trial completion date, Trial primary completion date:  MiDeTe - microRNA Levels Under Denosumab and Teriparatide Therapy in Postmenopausal Osteoporosis (clinicaltrials.gov) -  Oct 5, 2021   
    P4,  N=80, Active, not recruiting, 
    Denosumab, while off-label for this usage, offers an effective treatment option for immobilization-induced hypercalcemia though it carries a risk of hypocalcemia especially among patients with renal disease. Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Jun 2021 --> Jun 2022
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Retrospective data, Journal:  Is it safe to place implants in patients at risk of MRONJ? (Pubmed Central) -  Oct 3, 2021   
    There is a negligible risk of developing MRONJ in those taking denosumab for osteoporosis. However, practitioners should bear in mind a lack of high-quality evidence regarding the safety of placing implants in patients with a history of antiresorptive or anti-angiogenic medications.