Prolia (denosumab) / Amgen 
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  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Retrospective data, Journal:  Retrospective Analysis of the Effects of Non-Compliance with Denosumab on Changes in Bone Mineral Density During the COVID-19 Pandemic. (Pubmed Central) -  Jul 23, 2021   
    The difference between LS BMD indicates that there is a statistical difference between subjects who received denosumab injections between 5 and 7 months (near-standard dosing interval) and more than 9 months (P=0.03), but not in FN BMD, and no clinically significant association was identified. The results of this study show that in special clinical situations, such as the COVID-19 pandemic, clinicians may have some flexibility to prescribe denosumab, but the interval between injections should not exceed 9 months.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  The Treatment Gap in Osteoporosis. (Pubmed Central) -  Jul 20, 2021   
    Recently, romosozumab has been added as well...Knowledge of these could be very helpful in improving compliance and hopefully reducing the gap. In this paper, we summarize recent evidence regarding the efficacy of the various treatment options, potential side effects, and the overall benefit of treatment.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  A pragmatic window of opportunity to minimise the risk of MRONJ development in individuals with osteoporosis on Denosumab therapy: a hypothesis. (Pubmed Central) -  Jul 18, 2021   
    Based on the different pharmacological activity of denosumab and nitrogen-containing bisphosphonates, it is likely that the MRONJ risk profile of patients with osteoporosis could somewhat vary. We hypothesize the chance to maximize the pharmacokinetic of denosumab 60 mg (Prolia®) and identify a time interval in which invasive oral treatments can ideally take place without restrictions in patients with metabolic bone fragility, We propose that dental surgery (e.g. tooth extraction) may be safely performed without additional intra or peri-operative procedures in osteoporosis patients using denosumab provided that careful case selection, adequate communication among specialists, planning of a delayed dosing window (1-month deferral) and rigorous postoperative follow-up are granted.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  A Review on the Role of Denosumab in Fracture Prevention. (Pubmed Central) -  Jul 17, 2021   
    The safety profile of denosumab is consistent with increased years of exposure. In conclusion, denosumab is a safe and effective option for reducing fracture risk among patients with osteoporosis.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Radiomics on radiography predicts giant cell tumor histologic response to denosumab. (Pubmed Central) -  Jul 17, 2021   
    In conclusion, denosumab is a safe and effective option for reducing fracture risk among patients with osteoporosis. Radiomics analysis of plain radiographs quantifies time-dependent matrix mineralization and trabecular reconstitution that mark positive response of giant cell tumors of bone to denosumab.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Relationship Between Bone Mineral Density and Risk of Vertebral Fractures with Denosumab Treatment in Japanese Postmenopausal Women and Men with Osteoporosis. (Pubmed Central) -  Jul 16, 2021   
    P3
    Because there was no relationship between lumbar spine BMD change and T-score at 24 months of denosumab treatment, and because there can be small undetectable vertebral deformities that may increase BMD values, these results suggest that lumbar spine BMD change is not a good surrogate for vertebral fracture risk assessment. It is suggested that both total hip BMD change and T-score can be good surrogates for predicting vertebral fracture risk in Japanese patients with osteoporosis under denosumab treatment.ClinicalTrials.gov identifier: NCT00680953.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Pharmacological agents and natural compounds: available treatments for osteoporosis. (Pubmed Central) -  Jul 16, 2021   
    Anabolic drugs such as teriparatide, strontium ranelate, romosozumab have recently become available based on advanced clinical trials...In addition, possible mechanisms of action of all aforementioned treatments associated with bone remodelling, osteoclastogenesis, osteoblastogenesis, bone cell activity, death, and oxidative stress are presented. Nevertheless, more high-quality clinical studies with natural compounds are needed to provide greater evidence of the beneficial and safer antiosteoporotic application for the candidate.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  "Drugs to avoid" to improve quality use of medicines: how is Australia faring? (Pubmed Central) -  Jul 15, 2021   
    Medicines safety has become an Australian National Health Priority. Regulatory and reimbursement agencies should review the marketing and funding status of medicines which have not been shown to provide an efficacy and safety at least similar to alternative therapeutic options.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
    Journal:  Skeletal responses to romosozumab after 12 months of denosumab. (Pubmed Central) -  Jul 15, 2021   
    P2
    © 2021 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Review, Journal:  Assessment of Cardiovascular Safety of Anti-Osteoporosis Drugs. (Pubmed Central) -  Jul 14, 2021   
    Denosumab does not appear to be associated with cardiovascular disease and, although parathyroid hormone analogues are associated with palpitations and dizziness, no association with a defined cardiovascular pathology has been demonstrated. Finally, romosozumab has been shown to have a possible cardiovascular signal, and therefore post-market surveillance of this therapy will be vital.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Trial completion date, Trial primary completion date:  BAD: Alendronate in an Weekly Effervescent Tablet Formulation Following Denosumab Discontinuation (clinicaltrials.gov) -  Jul 14, 2021   
    P=N/A,  N=100, Recruiting, 
    Finally, romosozumab has been shown to have a possible cardiovascular signal, and therefore post-market surveillance of this therapy will be vital. Trial completion date: Apr 2022 --> Apr 2023 | Trial primary completion date: Oct 2021 --> Oct 2022
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Xofigo (radium Ra-223 dichloride) / Bayer
    [VIRTUAL] What's New in the Management of Hormone Naïve & Castrate Resistant Prostate Cancer: A Case-based Session for Urologists, Advanced Practice Providers and Teams (Marco Polo 801) -  Jul 13, 2021 - Abstract #AUA2021AUA_794;    
    We aim to allow urologists and their practice teams to be comfortable prescribing the following agents: abiraterone, enzalutamide, apalutamide, daralutamide, radium-223, denosumab, Sipuleucel-T and understand systemic chemotherapy, PARP inhibitors and emerging immunotherapy.Learning Objectives: List the three main advanced prostate cancer disease states (HSMPC); M0 CRPC and M1 CRPC) and be able to identify these patients in urologic practice.Identify FDA-hormonal and non-hormonal therapies for use in each of these three disease states: HSMPC, M0 CRPC, M1 CRPC.Demonstrate the safe use and unique mechanism of action and side effects of new and existing agents. Explain the sequencing of novel therapies and be able to identify patient progression of disease by PSA, imaging and signs and symptoms.Work in team care including urologists, advanced practice providers, oncology nursing, oncology pharmacy, medical oncology and radiation oncology and their support staffs.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Antiresorptive-Type and Discontinuation-Timing Affect ONJ Burden. (Pubmed Central) -  Jul 11, 2021   
    In contrast, discontinuation of either ZA or OPG-Fc in rats with established ONJ did not lead to ONJ resolution. In conclusion, our findings suggest that antiresorptive discontinuation is dependent on both the type of antiresorptive and the timing of discontinuation.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  "The use of bisphosphonates to treat skeletal complications in solid tumours". (Pubmed Central) -  Jul 11, 2021   
    Despite the success of denosumab in reducing osteolysis, bisphosphonates also remain mainstay drugs for treatment of metastatic bone disease. Recognizing the 50th Anniversary of the discovery of bisphosphonates, this review focuses on their continuing value in BM treatment and their future potential, for example in providing a bone-targeting vehicle for cytotoxic drugs.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial primary completion date:  Denosumab for Smoldering Multiple Myeloma (clinicaltrials.gov) -  Jul 8, 2021   
    P2,  N=20, Recruiting, 
    No abstract available Trial primary completion date: Jun 2021 --> Jun 2022
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Therapeutic targets in myeloma bone disease. (Pubmed Central) -  Jul 7, 2021   
    Current management of MBD includes antiresorptive agents, bisphosphonates and denosumab, that are only partially effective due to their inability to repair the existing lesions...Thus, research into agents that prevent bone destruction and more importantly repair existing lesions by inducing new bone formation, is of the utmost importance. This review discusses the mechanisms regulating the uncoupled bone remodelling in MM, and summarizes current advances in the treatment of MBD.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Overview of treatment approaches to osteoporosis. (Pubmed Central) -  Jul 7, 2021   
    Anti-resorptive therapies, including bisphosphonates and denosumab, increase bone mineral density (BMD) and reduce the risk of fractures by 20-70%...Treatment failure will often lead to switch of treatment from orally to parentally administrated anti-resorptives treatment or from anti-resorptive to bone-forming or dual-action treatment. Osteoporosis is a chronic condition and therefore needs a long-term management plan with a personalized approach to treatment.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Review, Journal:  Dental Implant Placement in Patients with a History of Medications Related to Osteonecrosis of the Jaws: A Systematic Review. (Pubmed Central) -  Jul 7, 2021   
    Importantly, all patients with a history of bisphosphonates are at risk of MRONJ, necessitating this to be included in the informed consent obtained prior to implant placement. The James Cook University College of Medicine and Dentistry Honours program and the Australian Dental Research Foundation Colin Cormie Grant were the primary sources of funding for this systematic review.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Observational data, Journal, Real-world evidence:  Risk factors for vertebral fractures and bone loss after denosumab discontinuation: A real-world observational study. (Pubmed Central) -  Jul 7, 2021   
    Compared to no subsequent therapy, zoledronate was associated with fewer vertebral fractures after denosumab. Further, BMD loss depended on denosumab treatment duration, age, prior BP therapy and BMD gain under denosumab therapy, whereas BTM levels were associated with bone loss at the total hip and denosumab treatment duration.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Management of Primary Hyperparathyroidism With Severe Hypercalcemia During the COVID-19 Pandemic. (Pubmed Central) -  Jul 7, 2021   
    However, osteoporosis treatment initiation still needs to be improved. Medical management of PHPT and severe hypercalcemia presents a reasonable alternative for parathyroid surgery during the COVID-19 outbreak and should be instituted until the pandemic ends and surgery can be performed safely.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Review, Journal:  The role of antiresorptive drugs and medication-related osteonecrosis of the jaw in nononcologic immunosuppressed patients: A systematic review. (Pubmed Central) -  Jul 6, 2021   
    However, more recently it has been observed in patients taking other medications, such as the RANK ligand inhibitor (denosumab) and antiangiogenic drugs...The data reviewed have confirmed that an invasive procedure is the commonest trigger of MRONJ with relatively high frequency of post-operative complications or recurrence following management. However, due to low-quality research available in the literature it is difficult to draw a definitive conclusion on the outcomes analysed in this systematic review.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Standard vs Cyclic Teriparatide and Denosumab Treatment for Osteoporosis: A Randomized Trial. (Pubmed Central) -  Jul 4, 2021   
    Although the Cyclic regimen did not improve BMD compared with Standard at 36 months, there appeared to be a benefit at 18 months, especially in the highly cortical skeletal sites. This could be clinically relevant in patients at high imminent risk of fracture, particularly at nonvertebral sites.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Controversies in the use of new bone-modifying therapies in multiple myeloma. (Pubmed Central) -  Jul 4, 2021   
    Three-monthly infusions of zoledronic acid or at-home denosumab administration should be considered during the coronavirus disease 2019 (COVID-19) pandemic. Measures to prevent hypocalcaemia, renal toxicity and osteonecrosis of the jaw are important for all bone-modifying agents.