Prolia (denosumab) / Amgen 
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  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Bone-Targeted Agents and Metastasis Prevention. (Pubmed Central) -  Jul 29, 2022   
    Denosumab, which has similar effects on bone cell physiology, appears not to consistently influence disease outcomes, perhaps suggesting that it is the "off target" effects of bisphosphonates on immune function and the biological processes involved in metastasis that are important. Predictive biomarkers beyond menopause are being sought and assessment of the transcription factor MAF (mesenchymal aponeurotic fibrosarcoma gene) appears to identify patients able to benefit from the addition of a bisphosphonate to standard adjuvant anticancer therapies.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    RANKL drives malignant phenotypes and poor prognosis in KRAS-mutated lung adenocarcinoma (Poster Area, Hall 4) -  Jul 28, 2022 - Abstract #ESMO2022ESMO_3379;    
    A retrospective cohort (n = 131) of advanced LUAD patients carrying bone metastases from the Chinese National Cancer Center treated with RANKL inhibitor denosumab (DN group) or phosphates (PS group) was used for clinical validation...Our single-center clinical cohort revealed a lower risk of disease progression in DN group than that in PS group (hazard ratio [HR] = 0.653, 95% confidence interval [CI]: 0.379-1.124, p = 0.156) for the overall population, and this trend was more pronounced in the KRAS-MT group (HR = 0.554, 95% CI: 0.256-1.202, p = 0.169), especially for KRAS-G12C subgroup (HR = 0.395, 95% CI: 0.105-1.485, p = 0.209), though significant differences were not confirmed. Conclusions RANKL further promotes the malignant phenotypes of KRAS-MT LUAD relative to KRAS-WT LUAD, and inhibition of RANKL may be a feasible strategy for KRAS-MT LUAD.
  • ||||||||||  Xofigo (radium Ra-223 dichloride) / Bayer
    Real-world association between bone targeted agents and palliative bone radiation in prostate cancer decedents: A province-wide study (Poster Area, Hall 4) -  Jul 28, 2022 - Abstract #ESMO2022ESMO_2062;    
    Bone targeted agents (BTA), such as denosumab and zoledronic acid, are shown to prevent and delay SREs...Results 1769 patients received LPT for mCRPC, including abiraterone (1094, 62%), docetaxel (881, 60%), enzalutamide (480, 27%), radium-223 (250, 14%) and cabazitaxel (108, 6%)...This suggests that clinicians are prescribing BTAs to patients at greater risk of SREs, but patients dying of prostate cancer continue to have significant bone-related morbidity despite contemporary prostate cancer treatment. An analysis of BTA use for primary versus secondary prevention of SREs is being conducted.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Pathological Fractures in Benign Bone Lesions - Diagnosis and Therapy. (Pubmed Central) -  Jul 27, 2022   
    In the presence of a locally aggressive bone tumour, as well as treating the fracture, it is usually necessary to perform curettage of the tumour - also en bloc resection, where applicable, in the case of a GCT. Depending on the location, benign, non-aggressive tumours can be treated conservatively if necessary.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
    Review, Journal:  Pros and Cons of Skeletal Medications in the COVID-19 Era. (Pubmed Central) -  Jul 27, 2022   
    In contrast, interruption of denosumab treatment is strongly discouraged because of rapid loss of bone mass and an associated increased risk for rebound vertebral fractures...The impact of the COVID-19 pandemic on long-term bone health remains unknown but focused interventions to ensure osteoporosis treatment initiation/maintenance should be implemented. Future studies are needed to determine whether osteoporosis medications have an impact on SARS-CoV-2 pathophysiology and COVID-19 clinical outcomes.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  The Impact of Frailty, Falls and Cognition on Osteoporosis Management in the Oldest Old. (Pubmed Central) -  Jul 24, 2022   
    82.5% were started on osteoporosis treatment with denosumab (43.4%) being the most prescribed, followed by alendronate (41.4%)...The presence of previous fractures was associated with initiation of osteoporosis medications, whereas frailty and falls had no impact on treatment decisions. Cognitive impairment and males were associated with a lower rate of initiation of osteoporosis medication.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Observational data, Retrospective data, Journal:  Treatment patterns of long-dose-interval medication for persistent management of osteoporosis in Taiwan. (Pubmed Central) -  Jul 24, 2022   
    Cognitive impairment and males were associated with a lower rate of initiation of osteoporosis medication. The real-world data reveal long-dose-interval therapy as an initial treatment or at the first switch stage may improve management of persistent AOM treatment.
  • ||||||||||  Prolia (denosumab) / Amgen
    Enrollment closed:  Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma (clinicaltrials.gov) -  Jul 23, 2022   
    P2,  N=25, Active, not recruiting, 
    The real-world data reveal long-dose-interval therapy as an initial treatment or at the first switch stage may improve management of persistent AOM treatment. Recruiting --> Active, not recruiting
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Observational data, Retrospective data, Journal:  Dispensing anti-osteoporotic drugs changed during the COVID-19 pandemic. (Pubmed Central) -  Jul 23, 2022   
    The observed decrease of DMAB during the first lockdown rebounded in the following months. Considering the massive treatment gap for osteoporosis, and the related fracture risk, clinicians should continue treatment, even during a pandemic.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal, PD(L)-1 Biomarker, IO biomarker:  Updated concepts in treatment of giant cell tumor of bone. (Pubmed Central) -  Jul 23, 2022   
    Randomized controlled trials are conducted on bisphosphonate-loaded bone cement and on optimal dose and duration of neoadjuvant denosumab. PD-L1 could be a potential new therapy target in GCTB.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Trends in osteoporosis diagnosis and management in Australia. (Pubmed Central) -  Jul 23, 2022   
    This suggests that policy changes permitting unlimited access to BMD measurement were associated with a reduction in osteoporotic fractures, but may also have been associated with overutilisation. Prospective studies to assess the efficacy of specific policies to ensure screening is performed in accordance with best-practice guidelines may be desirable.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Cancer Treatment-Induced Bone Loss: Role of Denosumab in Non-Metastatic Breast Cancer. (Pubmed Central) -  Jul 23, 2022   
    A majority (~60%) of the breast cancer patients in India are either estrogen (ER) or progesterone hormone receptor (PR) positive...Zoledronic acid, alendronate, risedronate and denosumab have been the agents of choice for managing bone loss...Denosumab has several advantages over other bone modifying agents such as subcutaneous self-administration by the patient themselves, no requirement of hospitalization, no dose modifications in renal impairment, and low incidence of acute phase anaphylactic reactions. We review the available evidence of denosumab for managing bone loss in non-metastatic breast cancer patients.
  • ||||||||||  Prolia (denosumab) / Amgen, Opdivo (nivolumab) / BMS
    Trial completion date, Trial primary completion date, IO biomarker:  Denosumab and Nivolumab Combination as 2d-line Therapy in Stage IV NSC Lung Cancer With Bone Metastases (DENIVOS) (clinicaltrials.gov) -  Jul 20, 2022   
    P2,  N=82, Active, not recruiting, 
    We review the available evidence of denosumab for managing bone loss in non-metastatic breast cancer patients. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  The importance of retaining physical functions to prevent skeletal-related events in multiple myeloma patients with bone disease. (Pubmed Central) -  Jul 20, 2022   
    This study was undertaken to identify baseline conditions and triggering factors for skeletal-related events (SRE) in multiple myeloma (MM) patients treated with denosumab...Bone fractures occurred by falling down due to orthostatic hypotension and/or muscle weakness in three out of four cases with amyloid light-chain (AL) amyloidosis. A loss of balance and falling down appear to be triggering factors for SRE, especially in frail MM patients with AL amyloidosis, indicating the importance of retaining physical functions to prevent SRE.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Denosumab and risk of community-acquired pneumonia: A population-based cohort study. (Pubmed Central) -  Jul 20, 2022   
    A loss of balance and falling down appear to be triggering factors for SRE, especially in frail MM patients with AL amyloidosis, indicating the importance of retaining physical functions to prevent SRE. Denosumab does not significantly increase the susceptibility of community-acquired pneumonia and could possibly be safely used for the management of osteoporosis.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial primary completion date:  Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant (clinicaltrials.gov) -  Jul 18, 2022   
    P2,  N=30, Active, not recruiting, 
    Despite a poor prognosis and an aggressive course of UPS of the spine, the tumor continues to be controlled without local recurrence four years after carbon ion radiotherapy. Trial primary completion date: Apr 2023 --> Dec 2022
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Faculty (In Person and Livestreamed A311-A312) -  Jul 16, 2022 - Abstract #ENDO2022ENDO_3079;    
    Not yet recruiting --> Recruiting Learning Objective 1:The participants will be able to explain and discuss the pathophysiology underlying the rebound increase in bone turnover and bone loss following discontinuation of denosumab Learning Objective 2:The participants will be able to understand and apply the current guidelines regarding follow-on treatment in patients discontinuing denosumab
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Treatment of Paget's Disease of the Skull With Denosumab: A Case Report () -  Jul 16, 2022 - Abstract #ENDO2022ENDO_2673;    
    Denosumab might be considered an effective treatment of Paget's disease of bone as well. Topical area for Clinical Case Reports: Bone and Mineral Metabolism Science Topic(s) for Bone and Mineral Metabolism: Other Metabolic Bone Diseases
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Severe Hypocalcemia and Hypophosphatemia Associated with Denosumab use in a Chronic Myeloid Leukemia Patient on Imatinib () -  Jul 16, 2022 - Abstract #ENDO2022ENDO_2650;    
    Topical area for Clinical Case Reports: Bone and Mineral Metabolism Science Topic(s) for Bone and Mineral Metabolism: Other Metabolic Bone Diseases Learning Objective 1: Understanding and analyzing the mechanism of severe hypocalcemia and hypophosphatemia of Denosumab use in clinical scenarios requiring Imatinib use Topical area for Clinical Case Reports: Bone and Mineral Metabolism Science Topic(s) for Bone and Mineral Metabolism: Osteoporosis, Phosphate Metabolism (including FGF23)
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Severe Hypercalcemia Following Denosumab Withdrawal in Giant Cell Tumor of Bone: A Double-edged Sword Treatment Paradigm? () -  Jul 16, 2022 - Abstract #ENDO2022ENDO_2649;    
    Learning Objective 1: To recognize severe hypercalcemia that can occur with denosumab withdrawal when treating osteolytic tumors : Giant Cell Tumor of Bone (GCTB) Learning Objective 2: To understand complex interactions when denosumab is discontinued in the setting of other drugs which alter mineral metabolism, such as FGFR inhibitors. Science Topic(s) for Bone and Mineral Metabolism: Other Metabolic Bone Diseases, Parathyroid Hormone, Phosphate Metabolism (including FGF23)
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Keeping An Eye On Bisphosphonates: Drug Induced Uveitis () -  Jul 16, 2022 - Abstract #ENDO2022ENDO_2588;    
    Learning Objective 2: Patients may benefit from switching to a different class of medications such as denosumab if they experience symptoms of ocular inflammation with bisphosphonates. Topical area for Clinical Case Reports: Bone and Mineral Metabolism, Miscellaneous Science Topic(s) for Bone and Mineral Metabolism: Healthcare Education, Osteoporosis
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Denosumab use for life-threatening hypercalcemia of malignancy in a toddler. A weight base dose () -  Jul 16, 2022 - Abstract #ENDO2022ENDO_2526;    
    Learning Objective 2: To identify risk factors associated with severe hypocalcemia Science Topic(s) for Bone and Mineral Metabolism: Other Metabolic Bone Diseases Learning Objective 1: Use of Denosumab for hypercalcemia of malignancy in children Learning Objective 2: Adress weight base dose for Denosumab in children with hypercalcemia of malignancy Topical area for Clinical Case Reports: Bone and Mineral Metabolism, Miscellaneous Science Topic(s) for Bone and Mineral Metabolism: Other Metabolic Bone Diseases
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Treatment of Paget's Disease of the Skull With Denosumab: A Case Report () -  Jul 16, 2022 - Abstract #ENDO2022ENDO_2321;    
    Our case report presents full recovery of Paget's disease of the skull with denosumab. This successful management suggests that denosumab might have an effective role in treating some cases of Paget's disease of the bone.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Severe Hypocalcemia and Hypophosphatemia Associated with Denosumab use in a Chronic Myeloid Leukemia Patient on Imatinib () -  Jul 16, 2022 - Abstract #ENDO2022ENDO_2157;    
    Recent data suggests the dysregulatory effect of long term Imatinib therapy on bone formation by inhibition of osteoclastic activity alongside transient increase in osteoblastic activity leading to retention and sequestration of calcium and phosphate in bone and decreasing circulating levels of these minerals. Our case brings to light the possibility of occurrence of severe hypocalcemia and hypophosphatemia in patients on Imatinib receiving Denosumab treatment and also raises the question regarding potentiation of the osteoclast inhibitory effect of Denosumab when used in conjunction with Imatinib.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Keeping An Eye On Bisphosphonates: Drug Induced Uveitis () -  Jul 16, 2022 - Abstract #ENDO2022ENDO_1781;    
    Because of these symptoms, the medication was stopped and she had an extensive rheumatology workup that was negative. An attempt to restart the medication resulted in worsening eye symptoms, so therapy was ultimately switched to denosumab.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Hypercalcemia in the Setting of HTLV-1 Infection and Normal PTHrP Levels () -  Jul 16, 2022 - Abstract #ENDO2022ENDO_1641;    
    While most cases of hypercalcemia of malignancy are driven by humoral mediators like PTHrP, a suppressed level of PTHrP, in the setting of a seemingly normal workup for hypercalcemia, like in our patient, does not rule out hypercalcemia of malignancy with the metabolic derangement being driven by other compounds like the RANK ligand. Experiments to support this have been conducted in animal models and in vitro human cell cultures and are further elucidated by the excellent response of hypercalcemia to Denosumab, a monoclonal antibody targeting the RANK Ligand.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Denosumab Induced Severe Hypophosphatemia () -  Jul 16, 2022 - Abstract #ENDO2022ENDO_1371;    
    We are presenting a unique case of a patient that developed severe hypophosphatemia after denosumab administration for treatment of bone metastases from prostate cancer. This case highlights the importance of monitoring serum phosphorus in patients who are candidates for treatment with denosumab, due the risk of developing severe hypophosphatemia which could be life threatening.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Denosumab as a therapuetic modality in management of primary hyperparathyroidism induced severe hypercalcemia () -  Jul 16, 2022 - Abstract #ENDO2022ENDO_1370;    
    Finally, Denosumab was used as rescue therapy to control hypercalcemia which resulted in gradual stabilization of serum calcium levels. We describe the clinical course along with management issues in our index case and enumerate the potential role of Denosumab in context of parathyroid adenoma induced hypercalcemic crisis.