Prolia (denosumab) / Amgen 
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  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  The Roadmap of RANKL/RANK Pathway in Cancer. (Pubmed Central) -  Nov 16, 2021   
    Targeting RANKL with the antibody denosumab is part of the standard of care for bone loss diseases, including bone metastases (BM)...RANKL/RANK pathway is also an important immune mediator, with anti-RANKL therapy recently linked to improved response to immunotherapy in melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC). This review summarizes and discusses the pre-clinical and clinical evidence of the relevance of the RANKL/RANK pathway in cancer biology and therapeutics, focusing on bone metastatic disease, BCa onset and progression, and immune modulation.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
    Journal:  Romosozumab Followed by Antiresorptive Treatment Increases the Probability of Achieving Bone Mineral Density Treatment Goals. (Pubmed Central) -  Nov 16, 2021   
    This review summarizes and discusses the pre-clinical and clinical evidence of the relevance of the RANKL/RANK pathway in cancer biology and therapeutics, focusing on bone metastatic disease, BCa onset and progression, and immune modulation. Here, we compare the probability of achieving a T-score of > -2.5 over 3 years at the total hip (TH) or lumbar spine (LS) in women with osteoporosis, ≥55 years of age, after the following treatment sequences: 1 year romosozumab followed by 2 years denosumab (FRAME and FRAME extension trials), 1 year romosozumab followed by 2 years alendronate, or alendronate-only for 3 years (ARCH trial).
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Giant cell tumor of the cervical spine treated by carbon ion radiotherapy: A case report. (Pubmed Central) -  Nov 12, 2021   
    PD-L1 and SIRPα immune checkpoint inhibitors may provide clinical benefit in GCTB patients with recurrent lesions after denosumab therapy. These findings suggest that carbon ion radiotherapy is a safe and effective therapeutic option for patients with recurrent GCT of the cervical spine.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Trial completion, Trial completion date, Trial primary completion date:  Alendronate Versus Denosumab in Kidney Transplant Patients (clinicaltrials.gov) -  Nov 12, 2021   
    P2/3,  N=90, Completed, 
    These findings suggest that carbon ion radiotherapy is a safe and effective therapeutic option for patients with recurrent GCT of the cervical spine. Active, not recruiting --> Completed | Trial completion date: Jan 2021 --> May 2021 | Trial primary completion date: Jan 2021 --> May 2021
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  All bone metastases are not created equal: Revisiting treatment resistance in renal cell carcinoma. (Pubmed Central) -  Nov 10, 2021   
    Resistance to these antiresportives in RCCBM reflects unique cellular and molecular mechanisms in the bone microenvironment that promote progression via inhibition of the anabolic reparative response. Identification of critical mechanisms underlying RCCBM induced anabolic impairment could provide needed insight into how to improve treatment outcomes for patients with RCCBM, with the goals of minimizing progression that necessitates palliative surgery and improving survival.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Pharmacological approaches for bone health in persons with spinal cord injury. (Pubmed Central) -  Nov 10, 2021   
    Denosumab has recently been reported to prevent bone loss in persons with acute SCI but should be continued for an as yet indeterminate time because discontinuation will result in rapid bone loss. Several other novel approaches to preserving bone at the time of acute SCI should be tested, as well as approaches to reverse bone loss in individuals with chronic SCI.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Long term osteoporosis treatment and other therapeutic considerations () -  Nov 7, 2021 - Abstract #APLAR2021APLAR_319;    
    Reduction of clinical and radiographic vertebral fractures as well as non-vertebral fractures are evident on use of bisphosphonates, denosumab, teriparatide, and abaloparatide, while risk of hip fracture has been shown in bisphosphonates and denosumab...Sequential therapy following an approach agreed upon by both the physician and the patient in order to maximize benefits of anti-osteoporosis medications on bone strength and fracture risk reduction is another important concept. Combination therapy (bone forming and anti-resorptives, anti-resorptives of different mechanism of actions) should be reserved for very rare circumstances.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Denosumab for the treatment of primary pediatric osteoporosis. (Pubmed Central) -  Nov 6, 2021   
    Transient hypercalcemia was probably due to amplification of the effect of growth spurt and puberty on bone remodeling by the transient, short-term discontinuation of the drug. Furthermore, our data suggest that mobilization of calcium from treatment-induced sclerotic transverse lines in bone metaphyses may contribute to the development of hypercalcemia.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Influence of denosumab on bone mineral density in a severe case of pregnancy-associated osteoporosis. (Pubmed Central) -  Nov 6, 2021   
    As the patient had regular menstrual cycles and considered a further pregnancy, denosumab treatment was terminated and soon a second pregnancy occurred. After the second pregnancy, BMD decreased at the lumbar spine, femur neck, and total hip by -8.8%, -6.9%, and -7.0% respectively compared to the maximum values during treatment with denosumab, but was still significantly higher compared to baseline levels with no further fractures.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Review, Journal:  Values and other decisional factors regarding treatment of hypercalcaemia of malignancy: a systematic review protocol. (Pubmed Central) -  Nov 5, 2021   
    Several treatment options are available including pharmacological therapy with bisphosphonates, denosumab, glucocorticoids and calcimimetics, as well as conventional therapy with hydration and possibly calcitonin...Ethical approval is not applicable for our study, since we will only collect data from available literature. This systematic review will be submitted to a peer-reviewed journal when completed.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Effects of Medical Treatment of Prostate Cancer on Bone Health. (Pubmed Central) -  Nov 4, 2021   
    Bone antiresorptive agents [selective estrogen receptor modulators (SERMS), bisphosphonates, and denosumab] increase bone mineral density (BMD) and in some instances reduce fracture risk in PC patients on ADT. Awareness and management of bone health in PC can be improved by integrating endocrinologists into the multidisciplinary PC team.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Short-term efficacy and safety of zoledronate acid or denosumab in Japanese patients with postmenopausal osteoporosis. (Pubmed Central) -  Nov 4, 2021   
    The combination therapy of Zol or DMAb and ELD may increase BMD at 12 months after the first administration in Japanese patients with postmenopausal osteoporosis, regardless of BPs pretreatment. Bone metabolic markers at baseline may be useful predictors for reaction to the therapy and side effects caused by these combination therapies in postmenopausal osteoporosis.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Retrospective data, Review, Journal:  Biomechanical mechanisms of atypical femoral fracture. (Pubmed Central) -  Nov 4, 2021   
    Antiresorptives such as bisphosphonates (BP) and denosumab are commonly used osteoporosis treatments that are effective in preventing osteoporotic fractures by suppressing bone turnover...The review focuses on three major potential mechanical mechanisms of AFF based on the current literature which are (1) macroscale femoral geometry which influences the stress/strain distribution in the femur under loading; (2) bone matrix composition, potentially altered by long-term remodeling suppression by BPs, which directly influences the material properties of bone and its mechanical behavior; and (3) microstructure, potentially altered by long-term remodeling suppression by BPs, which impacts fracture resistance through interaction with crack propagation. In addition, this review presents the critical knowledge gaps in understanding AFF and also discusses approaches to closing the knowledge gap in understanding the underlying mechanisms of AFF.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Denosumab for the treatment of HIV-associated osteoporosis with fractures in a premenopausal woman. (Pubmed Central) -  Oct 30, 2021   
    After four years of treatment, bone mineral density improved, no new fractures occurred, and neither HIV reactivation nor opportunistic infections were observed. We show that denosumab could be a safe and effective approach for osteoporosis in patients with HIV and could be considered in women of childbearing age.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Depression and anxiety in recurrent giant cell tumor of bone. (Pubmed Central) -  Oct 30, 2021   
    The patients can be treated with pharmacological agents (Denosumab), surgery with tumor excision, reconstruction or osteosynthesis, and radiotherapy...It is necessary to evaluate in a multidisciplinary team to avoid unfavorable oncological and psychiatric developments. Through its clinical, HP, and therapeutic features, GCTB has multiple connections with the psychological and psychopathological dimension.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal, HEOR, Real-world evidence:  Real-world cost-effectiveness of denosumab for the treatment of postmenopausal osteoporosis in Taiwan. (Pubmed Central) -  Oct 30, 2021   
    In accordance with current literature, the applied protocol showed a reliable outcome in preventing ARONJ when a tooth extraction is required. In a real-world setting, at a cost per QALY threshold equivalent to gross domestic product per capita in 2020 in Taiwan (USD $30,038), continued treatment with denosumab in postmenopausal women with osteoporosis is cost-effective compared with treatment discontinuation.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Review, Journal:  BONE METASTASES IN NEUROENDOCRINE TUMORS: MOLECULAR PATHOGENESIS AND IMPLICATIONS IN CLINICAL PRACTICE. (Pubmed Central) -  Oct 29, 2021   
    While it is currently unclear whether or not the earlier recognition of bone involvement by PET/CT imaging techniques employing 68Ga-DOTA-conjugated peptides might improve outcomes through the exploitation of timely treatments, the management of bone-colonizing NETs is today based only on clinical experience from other osteotropic tumors. Here, we summarize the fundamental molecular mechanisms driving bone colonization and revisit both established and novel treatments for patients with bone metastatic NETs.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal, Real-world evidence:  Long-Term Follow-Up of Denosumab Discontinuers with Multiple Vertebral Fractures in the Real-World: A Case Series. (Pubmed Central) -  Oct 28, 2021   
    This long-term follow-up of real-world patients with MVF following denosumab discontinuation reveals that management is inconsistent, and recurrent fractures are not uncommon. It calls for clear management guidelines for patients with MVF after denosumab discontinuation and for special attention to this high-risk group.