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


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  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Glucocorticoid-induced osteoporosis-Focus treatment (part 2) (Pubmed Central) -  Mar 8, 2022   
    The severity of osteoporosis, especially the presence of osteoporotic fractures, the approach of treatment (preventive or curative) and contraindications are factors that are important for the differentiated application of the mentioned substances. Furthermore, it must be noted that the effect of osteoanabolic treatment must be stabilized by a subsequent antiresorptive treatment and that after termination of antiresorptive treatment with denosumab a temporary bisphosphonate treatment is required to prevent a rebound phenomenon.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Use of Adjuvant Bisphosphonates and Other Bone-Modifying Agents in Breast Cancer: ASCO-OH (CCO) Guideline Update. (Pubmed Central) -  Mar 8, 2022   
    The Panel supports starting bisphosphonate therapy early, consistent with the points outlined in the parent CCO-ASCO guideline; this is a consensus recommendation. The Panel does not recommend adjuvant denosumab to prevent breast cancer recurrence, because studies did not show a consistent reduction of breast cancer recurrence in any subset of those with early-stage breast cancer.Additional information can be found at www.asco.org/breast-cancer-guideline.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Biomarker, Journal:  Advances in Bone Turnover Markers (PINP and CTX) in Optimizing Anti-resorptive and Anabolic Therapies Against Osteoporosis. (Pubmed Central) -  Mar 8, 2022   
    The numerical changes and clinical significance of BTMs in two therapies are summarized and the practical application and potential value of PINP and CTX as therapeutic target, threshold of follow-up therapy, and evaluation of fracture risk in different regimes such as bisphosphonates, denosumab, raloxifene, teriparatide, abaloparatide, and romosozumab are reviewed in this paper. The application of BTMs is expected to improve the efficacy of the treatments and reduce the rate of osteoporotic fracture in clinical practice.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Spontaneous medication-related osteonecrosis of the jaw: a bimodal treatment approach. (Pubmed Central) -  Mar 8, 2022   
    In addition, the patient was prescribed the antiresorptive drug denosumab for osteoporosis...The patient is often unaware of the exposed bone, which is relatively painless. Patients with complicated medical histories, who often are treated by multiple medical practitioners and prescribed multiple medications for different conditions, may require a similar bimodal treatment approach.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial primary completion date:  Denosumab Safety Assessment in Multiple Observational Databases (clinicaltrials.gov) -  Mar 8, 2022   
    P=N/A,  N=508215, Active, not recruiting, 
    Patients with complicated medical histories, who often are treated by multiple medical practitioners and prescribed multiple medications for different conditions, may require a similar bimodal treatment approach. Trial primary completion date: Mar 2024 --> Jun 2023
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Hypercalcemia Secondary to Relapsed Subcutaneous Sarcoidosis () -  Mar 6, 2022 - Abstract #NKFSCM2022NKF_SCM_810;    
    The patient was then started on oral Prednisone 50 mg daily...CONCLUSION In PTH independent Hypercalcemia, without evidence of malignancy, sarcoidosis should be considered as a unifying diagnosis. Physicians should have a high index of suspicion for sarcoidosis recurrence in patients who present with refractory hypercalcemia despite the absence of supportive clinical findings of SS.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Back to Basics with Denosumab Induced Severe Hypophosphatemia () -  Mar 6, 2022 - Abstract #NKFSCM2022NKF_SCM_599;    
    However, patients with prostate cancer with bone metastasis can have severe life-threatening hypophosphatemia if treated with denosumab. We believe that by increasing the awareness and enhancing the expertise among the medical community to early diagnose and treat denosumab induced hypophosphatemia can help reduce the morbidity and mortality associated with it.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
    Refractory Hypercalcemia due to Ectopic Production of Calcitriol in Malignant Sarcomatoid Mesothelioma () -  Mar 6, 2022 - Abstract #NKFSCM2022NKF_SCM_577;    
    CONCLUSION We present this rare case of hypercalcemia of malignancy due to tumor production of 1,25-dihydroxyvitamin D, refractory to bisphosphonates, denosumab and calcitonin. While both prednisone and hemodialysis are possible therapeutic options for resistant hypercalcemia of malignancy, our patient decided to forego treatment and instead opted for hospice after learning of progression of disease on repeat imaging.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Giant cell tumor of bone: A single center study of 115 cases. (Pubmed Central) -  Mar 5, 2022   
    GCTB recurs frequently after intralesional curettage and cement augmentation. While denosumab is a potential (neo-)adjuvant treatment option that might be used for lesions that are difficult to resect, surgeons should be aware that LR is still frequent.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Observational data, Journal:  Denosumab vs. zoledronic acid treatment in post-menopausal breast cancer: a 2-year prospective observational study. (Pubmed Central) -  Mar 4, 2022   
    Our data indicate that for BC patients in AI treatment who refused or were not able to receive ZA treatment, denosumab might be recommended as a second choice. Regarding markers of bone turnover and BMD denosumab is equal to ZA.Summary: Women with early breast cancer receiving anti-estrogen treatment are at risk of developing osteoporosis.We followed 194 women receiving zoledronic acid (ZA) or denosumab for up to 2 years.We find that with regard to bone protection, denosumab is a viable alternative to ZA and might be recommended as a second choice.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Tooth extractions in patients with cancer receiving high-dose antiresorptive medication: a randomized clinical feasibility trial of drug holiday versus drug continuation. (Pubmed Central) -  Mar 4, 2022   
    Regarding markers of bone turnover and BMD denosumab is equal to ZA.Summary: Women with early breast cancer receiving anti-estrogen treatment are at risk of developing osteoporosis.We followed 194 women receiving zoledronic acid (ZA) or denosumab for up to 2 years.We find that with regard to bone protection, denosumab is a viable alternative to ZA and might be recommended as a second choice. The results indicate that a high-dose AR drug holiday does not prevent development of MRONJ after surgical tooth extraction and that patient-reported health state declines during a drug holiday compared with drug continuation.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Regulation of TNF-Induced Osteoclast Differentiation. (Pubmed Central) -  Mar 4, 2022   
    However, there is a specific concern of a rebound effect of denosumab discontinuation in treating osteoporosis...However, TNFα polarized macrophages also produce anabolic factors, including insulin such as 6 peptide and Jagged1, to slow down bone loss in the pathological conditions. Thus, the development of novel approaches targeting TNFα signaling should focus on its downstream molecules that do not affect its anabolic effect.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Denosumab might prevent periprosthetic bone loss after total hip and knee arthroplasties: a review. (Pubmed Central) -  Mar 4, 2022   
    This article reviews the present findings and evidence concerning the effect of denosumab on the periprosthetic bone loss after total hip arthroplasty and total knee arthroplasty. Overall, the current evidence suggests that denosumab is a promising agent for the treatment of periprosthetic bone loss.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal, Patient reported outcomes:  Patient Reported Outcomes in Pediatric Cancer Registration Trials: A U.S. Food and Drug Administration Perspective. (Pubmed Central) -  Feb 25, 2022   
    When used, PRO data were limited by lack of a clear research objective and corresponding prospective statistical analysis plan. Contemporary PRO symptom libraries such as the National Cancer Institute's Pediatric PRO-CTCAE may provide an opportunity to better evaluate the occurrence and impact of symptomatic Adverse Events, from the patient's perspective, in pediatric oncology trials.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Preclinical, Journal:  Osteonecrosis development by tooth extraction in zoledronate treated mice is inhibited by active vitamin D analogues, anti-inflammatory agents or antibiotics. (Pubmed Central) -  Feb 24, 2022   
    Invasive dental treatment such as tooth extraction following treatment with strong anti-bone resorptive agents, including bisphosphonates and denosumab, reportedly promotes osteonecrosis of the jaw (ONJ) at the extraction site, but strategies to prevent ONJ remain unclear...Specifically, tooth extraction during treatment with zoledronate induced osteonecrosis in mice, but administration of either 1,25(OH)D or ED71, both active vitamin D analogues, significantly antagonized osteonecrosis development, even under continuous zoledronate treatment...Furthermore, administration of either anti-inflammatory or antibiotic reagents significantly blocked ONJ development following tooth extraction and zoledronate treatment. These findings suggest that administration of active vitamin D, anti-inflammatory agents or antibiotics could prevent ONJ development induced by tooth extraction in patients treated with zoledronate.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Hemodynamic Instability Associated with Spontaneous Carcinoid Crisis (Room 3009/3011 (West Building, Level 3), Moscone Center) -  Feb 19, 2022 - Abstract #ATS2022ATS_2029;    
    He underwent palliative chemotherapy and was stable on outpatient octreotide and denosumab...A high degree of suspicion is required to diagnose this condition outside of the perioperative setting. Somatostatin analogues remain first line therapy despite questionable efficacy.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Enrollment closed, Enrollment change, Trial primary completion date:  Denosumab Treatment for Fibrous Dysplasia (clinicaltrials.gov) -  Feb 18, 2022   
    P2,  N=9, Active, not recruiting, 
    Somatostatin analogues remain first line therapy despite questionable efficacy. Enrolling by invitation --> Active, not recruiting | N=14 --> 9 | Trial primary completion date: Mar 2026 --> Nov 2021
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Editorial: Management of Bone Disorders in Children. (Pubmed Central) -  Feb 12, 2022   
    Enrolling by invitation --> Active, not recruiting | N=14 --> 9 | Trial primary completion date: Mar 2026 --> Nov 2021 No abstract available
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Incidence of Antiresorptive Agent-Related Osteonecrosis of the Jaw in Urologic Cancers (Pubmed Central) -  Feb 11, 2022   
    Time-to-ARONJ was shorter in patients treated with denosumab than in patients treated with zoledronic acid. The occurrence of ARONJ may be underestimated; therefore, further studies are needed to investigate the actual frequency of ARONJ in Japan.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Review, Journal:  Successful treatment with denosumab for pelvic fibrous dysplasia: A case report and review of the literature. (Pubmed Central) -  Feb 8, 2022   
    We described successful denosumab treatment in a patient with cystic fibrous dysplasia (FD) who maintained efficacy for 9 months after treatment. Although the use of denosumab in fibrous dysplasia is currently off-label, our experience with this patient supports the potential of denosumab therapy for patients for whom surgical treatment is challenging.