Prolia (denosumab) / Amgen 
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  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Revlimid (lenalidomide) / BMS
    Biomarker, Review, Journal:  Management of Myeloma Bone Lesions. (Pubmed Central) -  Jun 12, 2021   
    In addition, several other bone-targeting agents, including bone-anabolic drugs, are currently used in preclinical and early clinical evaluations. This review summarizes the current knowledge of the pathogenesis of MBD and discusses novel agents that appear very promising and will soon enter clinical development.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Refractory hypercalcaemia associated with disseminated Cryptococcus neoformans infection. (Pubmed Central) -  Jun 11, 2021   
    A disseminated fungal infection should be suspected in immunosuppressed individuals presenting with hypercalcaemia. In immunocompromised patients with unexplained hypercalcaemia, fungal infections should be considered as the differential diagnoses; Glucocorticoids may be considered to treat 1,25-OH D-driven hypercalcaemia; however, the benefits of lowering the calcium need to be balanced against the risk of exacerbating an underlying infection; Fluconazole might be an effective therapy for both treatment of the hypercalcaemia by lowering 1,25-OH D levels as well as of the fungal infection.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Should denosumab treatment for osteoporosis be continued indefinitely? (Pubmed Central) -  Jun 10, 2021   
    However, discontinuation of denosumab may happen due to non-adherence; potential lack of efficacy in an individual; where reimbursement for therapy is limited to those with bone mineral density in the osteoporosis range, when assessment reveals this has been exceeded; or patient or physician concern regarding side effects. This review paper aims to discuss these concerns and to summarize the data available to date regarding sequential osteoporosis therapy following denosumab cessation to reduce the risk of multiple vertebral fracture.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Risk factors for skeletal-related events in non-small cell lung cancer patients treated with bone-modifying agents. (Pubmed Central) -  Jun 9, 2021   
    This review paper aims to discuss these concerns and to summarize the data available to date regarding sequential osteoporosis therapy following denosumab cessation to reduce the risk of multiple vertebral fracture. Careful observation is needed for patients with the identified risk factors, which include poor PS and male sex, despite the BMA treatment.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Practical update for the use of bone-targeted agents in patients with bone metastases from metastatic breast cancer or castration-resistant prostate cancer. (Pubmed Central) -  Jun 8, 2021   
    In this review, we discuss key practical themes regarding the use of bone-targeted agents (btas) such as bisphosphonates and denosumab for managing bony metastatic disease...The collaboration of all disciplines is essential for optimal patient care. Special consideration is given to these key questions: ■ What are btas, and what is their efficacy?■ What are their common toxicities?■ When should they be initiated?■ How do we choose the appropriate bta?■ What is the appropriate dose, schedule, and duration of btas?
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal, Real-world evidence:  Osteosarcopenia in Very Old Age Adults After Hip Fracture: A Real-World Therapeutic Standpoint. (Pubmed Central) -  Jun 8, 2021   
    The results showed a slightly and non-significant osteo-metabolic improvement in the Alendronate group compared to the Denosumab group, and a positive trend of RSMI measurements in the Denosumab group. Although preliminary in nature, this is the first report to longitudinally analyze osteosarcopenia in a real-world cohort of very old age patients after hip fracture and moved a step forward in the understanding of the best osteo-metabolic therapy for long- term treatment, exploring as well the potential dual role of denousumab as antiresorptive and muscle strength specific drug for osteosarcopenia in this vulnerable population.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    [VIRTUAL] Severe Hypocalcemia () -  Jun 7, 2021 - Abstract #AACE2021AACE_542;    
    We present a patient with bone disease due to MM who developed severe hypocalcemia in the setting of 25-hydroxy vitamin D (VITD) deficiency. The case highlights the importance of recognizing VITD deficiency as a modifiable risk factor in the prevention of denosumab-induced hypocalcemia.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    [VIRTUAL] Management of Denosumab-induced Hypocalcemia () -  Jun 7, 2021 - Abstract #AACE2021AACE_450;    
    However, treatment can be associated with severe hypocalcemia. We present a case of a patient with metastatic prostate cancer who developed severe hypocalcemia following denosumab treatment.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    [VIRTUAL] Elevated Parathyroid Hormone Levels Following Denosumab Treatment () -  Jun 7, 2021 - Abstract #AACE2021AACE_387;    
    Denosumab has also been associated with a compensatory increase in parathyroid hormone (PTH) levels during the first few months after injection, especially in the setting of chronic kidney disease. Here we report notable transitory PTH elevations after denosumab administration in two patients.
  • ||||||||||  Boyoubei (denosumab biosimilar) / Luye Group
    Enrollment open:  Efficacy and Safety of LY01011 and Xgeva (clinicaltrials.gov) -  Jun 7, 2021   
    P3,  N=850, Recruiting, 
    We present an unusual case of rapid-onset and severe hypocalcemia in a patient with normal renal function, skeletal metastasis and high bone turnover. Not yet recruiting --> Recruiting
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Outcome of lung metastases due to bone giant cell tumor initially managed with observation. (Pubmed Central) -  Jun 3, 2021   
    According to radiological imaging, approximately half of the patients progressed, and approximately half required a metastasectomy or denosumab treatment. However, patients with lung nodules > 5 mm should receive careful observation because of the high rate of disease progression in this group.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Infection as an Important Factor in Medication-Related Osteonecrosis of the Jaw (MRONJ). (Pubmed Central) -  Jun 3, 2021   
    This observation is very critical in order to implement policies to reduce the risk of MRONJ in patients under antiresorptive drugs. This critical review was conducted to collect the most reliable evidence regarding the link between local infection and MRONJ pathogenesis.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Retrospective data, Journal:  Microarchitecture of medication-related osteonecrosis of the jaw (MRONJ); a retrospective micro-CT and morphometric analysis. (Pubmed Central) -  Jun 2, 2021   
    Medication-related osteonecrosis of the jaw (MRONJ) is a severe side effect of antiresorptive (AR) drugs such as bisphosphonates (BP) and denosumab (Dmab)...This result might also suggest a high risk to microcrack accumulation. At some point, possibly some kind of over-ossification could lead to under-nourishment and microarchitectural weakness, creating instability, subsequently increasing vulnerability to MRONJ.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Contributing factors to the initial femoral stem migration in cementless total hip arthroplasty of postmenopausal women. (Pubmed Central) -  May 28, 2021   
    Based on analysis of covariance, which controlled for outliers and randomized antiresorptive treatment with denosumab or placebo, none of the analyzed demographics (including BMI) and surgery-related variables (including the stem-to-canal fil ratio) was associated with stem subsidence...This observation confirms the previous results of instrumented hip prostheses on torsional moments affecting stems during daily activities. High-resolution imaging modalities of local bone quality are needed to explore reasons for RSA-measurable stem subsidence even in women with normal hip BMD.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Choosing the Right Partner for Medication Related Osteonecrosis of the Jaw: What Central European Dentists Know. (Pubmed Central) -  May 28, 2021   
    Due to the considerable lack of knowledge regarding MRONJ among dentists, MRONJ patients and subjects at risk should be guided towards specialists for dental screening, treatment, and follow-up. This is important from an oncologic point of view to avoid any delay for treatment start of antiresorptives, and to reveal a potentially emerging osteonecrosis at an early stage, thus, avoiding the need for interruption or even cancellation of antiresorptive therapy.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Elevated Bone Hardness Under Denosumab Treatment, With Persisting Lower Osteocyte Viability During Discontinuation. (Pubmed Central) -  May 27, 2021   
    In biopsies from patients with high fracture occurrence, denosumab treatment reduced osteocyte viability, an effect that persisted during treatment discontinuation. High-resolution imaging of osteocyte viability indicates a role for osteocytes as a potential future mechanistic target to understand rebound bone loss and increased fractures with denosumab discontinuation.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion:  RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints (clinicaltrials.gov) -  May 26, 2021   
    P2,  N=100, Completed, 
    High-resolution imaging of osteocyte viability indicates a role for osteocytes as a potential future mechanistic target to understand rebound bone loss and increased fractures with denosumab discontinuation. Active, not recruiting --> Completed
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Is a Short-course of Preoperative Denosumab as Effective as Prolonged Therapy for Giant Cell Tumor of Bone? (Pubmed Central) -  May 25, 2021   
    Denosumab must be used cautiously before curettage for GCTB, and only if the benefit of joint salvage outweighs the possibility of LR. However, given the small number of patients, potentially clinically important differences might have been missed, and so our findings need to be confirmed by larger, multicenter, prospective trials.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Survival in older women with early stage breast cancer receiving low-dose bisphosphonates or denosumab. (Pubmed Central) -  May 22, 2021   
    Our results support and confirm the role of Radium-223 therapy on OS and, furthermore, appear to confirm that BHA treatment has not a survival benefit. Bisphosphonates at the doses recommended for osteoporosis are associated with improved survival in older postmenopausal women with early breast cancer.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    [VIRTUAL] ANTIRESORPTIVE THERAPY AFTER TERIPARATIDE DISCONTINUATION – WHEN IS THE BEST TIME TO STARTING IT? (Posters Viewing) -  May 21, 2021 - Abstract #EULAR2021EULAR_3414;    
    Although this study is unable to show that anti-resorptive treatment should be started in the first year after discontinuation of TPTD, it is promising since the difference between the medians in the total hip BMD values obtained until one year and after one year are marginally significant. These results can be linked to the small sample size and highlight the need for further studies in this area.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  An update on vascular calcification and potential therapeutics. (Pubmed Central) -  May 21, 2021   
    The interventions include phosphate binders, sodium thiosulphate, vitamin K, calcimimetics, vitamin D, bisphosphonates, Myoinositol hexaphosphate (IP6), Denosumab and TNAP inhibitors...This review focuses on the relationship of vascular calcification to clinical diseases, regulators and factors causing calcification including genetics which have been identified. At present, there is lack of any significant preventive measures for calcifications and hence this review explores further possibilities for drug development and treatment modalities.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Review, Journal, BRCA Biomarker:  Nonsurgical Prevention Strategies in BRCA1 and BRCA2 Mutation Carriers. (Pubmed Central) -  May 21, 2021   
    Recently, denosumab, a well-tolerated osteoprotective drug, has been shown to have an antitumoral effect on RANK+, BRCA1-deficient luminal progenitor cells in vitro, and has been demonstrated to abrogate tumors in BRCA1-deficient mouse models. The prospectively randomized, double-blind BRCA-P trial is currently investigating the preventative effect of denosumab in healthy BRCA1 germline mutation carriers.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Retrospective data, Journal:  The progress of medication-related osteonecrosis of the jaw with conservative initial treatment: A 12-year retrospective study of 129 patients. (Pubmed Central) -  May 20, 2021   
    The factors examined included sex, age, stage of MRONJ (1-3), type of bone modifying agents (bisphosphonate or denosumab), primary disease (osteoporosis or malignant tumor), medical history (diabetes and rheumatoid arthritis), use of corticosteroids, the trigger of MRONJ (teeth extraction or others), and separation of sequestrum, using logistic regression analysis...MRONJ had a poor prognosis with conventional treatment carried according to the stage of the disease. This was especially prominent when conservative treatment was employed for mild cases.