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


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  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinicopathologic Characteristics of Giant Cell Tumor of Bone with Malignant Transformation (Poster Board Number: 46; LACC West Exhibit Hall A) -  Dec 13, 2021 - Abstract #USCAP2022USCAP_1307;    
    In this cohort, 4 of 13 patients were known to have denosumab treatment prior to sarcomatous transformation of GCTB. Additional investigations are needed to better characterize underlying mechanisms in sarcomatous transformation.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Enrollment change, Trial termination:  Pilot Study of Denosumab in BRCA1/2 Mutation Carriers Scheduled for Risk-Reducing Salpingo-Oophorectomy (clinicaltrials.gov) -  Dec 8, 2021   
    P1,  N=1, Terminated, 
    Additional investigations are needed to better characterize underlying mechanisms in sarcomatous transformation. N=60 --> 1 | Suspended --> Terminated; it was decided that due to lack of accrual on the trial, and low potential for accruing over the near future, the trial will be shut down.
  • ||||||||||  Prolia (denosumab) / Amgen
    Enrollment open, Trial primary completion date, Head-to-Head:  REDUSE: Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks (clinicaltrials.gov) -  Dec 7, 2021   
    P3,  N=1380, Recruiting, 
    N=60 --> 1 | Suspended --> Terminated; it was decided that due to lack of accrual on the trial, and low potential for accruing over the near future, the trial will be shut down. Active, not recruiting --> Recruiting | Trial primary completion date: Dec 2021 --> Dec 2022
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion date, Trial primary completion date:  Study of XGEVA (clinicaltrials.gov) -  Dec 3, 2021   
    P4,  N=35, Not yet recruiting, 
    Active, not recruiting --> Recruiting | Trial primary completion date: Dec 2021 --> Dec 2022 Trial completion date: Oct 2026 --> Oct 2027 | Trial primary completion date: Oct 2026 --> Oct 2027
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Promoting bone health in children and adolescents following solid organ transplantation. (Pubmed Central) -  Dec 1, 2021   
    Dual-energy X-ray absorptiometry can be useful to detect abnormal bone mass and fracture risk in this population and newer bone assessment methods are being evaluated in children at risk for poor bone outcomes. Newer bone therapies being explored in adults with transplants, particularly bisphosphonates and the RANKL inhibitor denosumab, may offer promise for children with low bone mass post-transplantation.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Metastasectomy Versus Non-Metastasectomy for Giant Cell Tumor of Bone Lung Metastases. (Pubmed Central) -  Nov 29, 2021   
    The biological behaviors and clinical courses of lung metastases are difficult to predict, and their treatment recommendations vary, including metastasectomy and non-metastasectomy with chemotherapy (denosumab, interferon-alfa, bisphosphonates), with radiation therapy, or with observation alone...[Orthopedics. 2021;44(x):xx-xx.].
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Hypercalcemia following discontinuation of denosumab therapy: A systematic review. (Pubmed Central) -  Nov 29, 2021   
    These results may further underscore that high bone formation and bone turnover rates are critically associated with hypercalcemia after the discontinuation of denosumab. In contrast, given that not all skeletally immature patients develop hypercalcemia, it is probable that other unidentified factors are involved in the pathology of this condition.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    NEOADJUVANT DENOSUMAB IN GCT. LONG TERM INJECTION CAN DECREASE THE RISK OF LOCAL RECURRENCE ([VIRTUAL]) -  Nov 26, 2021 - Abstract #CTOS2021CTOS_364;    
    The minimum number of neoadjuvant denosumab is determined, which reduces the risk of LR in a case of attenuated surgery. Despite an increase of LR rate (statistically insignificant, p > 0.05) combined treatment with neoadjuvant denosumab for patients with anatomically complex localization of GCT is the preferred method, especially with high risks of postoperative complications after mutilating surgery.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  The incidence of medication-related osteonecrosis of the jaw following tooth extraction in patients prescribed oral bisphosphonates. (Pubmed Central) -  Nov 25, 2021   
    Patients with previous or current exposure to intravenous bisphosphonates, denosumab, novel-targeted chemotherapies used in the oncology setting or radiotherapy to the head and neck were excluded from this study.Results The incidence of medication-related osteonecrosis of the jaw following tooth extraction in this group of 652 was 0.8%. A significantly increased risk of developing medication-related osteonecrosis of the jaw was evident in patients prescribed oral bisphosphonates for four years or more (p = 0.02), with an incidence in this group of 1.6%.Conclusion This study demonstrates that, following dental extraction, patients who are prescribed oral bisphosphonates are at risk of developing medication-related osteonecrosis of the jaw and that this risk increases significantly when the patient has been taking the bisphosphonate for four years or more.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
    Journal:  Denosumab versus romosozumab for postmenopausal osteoporosis treatment. (Pubmed Central) -  Nov 24, 2021   
    Adverse events were few and predominantly minor in both groups, with no remarkable difference in the incidence of new vertebral fractures. Romosozumab showed a higher potential for improving BMD than denosumab in this clinical study of postmenopausal osteoporosis patient treatment.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Observational data, Journal, HEOR:  Influence of Preventive Tooth Extractions on Quality of Life in Patients with Antiresorptive Intake-A Prospective Longitudinal Study. (Pubmed Central) -  Nov 24, 2021   
    Patients were stratified as high-risk (malignant disease with bone metastasis or multiple myeloma, with monthly high-dose antiresorptive therapy delivered intravenously [bisphosphonate] or subcutaneously [denosumab]) and low-risk/osteoporosis patients (weekly low-dose antiresorptive therapy administered orally [bisphosphonate] or half-yearly subcutaneously [denosumab])...Therefore, if indicated, preventive tooth extraction should not be omitted. Patient-oriented outcome measures are important to obtain a good risk-benefit balance for patient-specific treatment.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion, Enrollment change, Trial completion date, Combination therapy:  Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases (clinicaltrials.gov) -  Nov 23, 2021   
    P2,  N=6, Completed, 
    Patient-oriented outcome measures are important to obtain a good risk-benefit balance for patient-specific treatment. Active, not recruiting --> Completed | N=50 --> 6 | Trial completion date: Dec 2021 --> Dec 2020
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Pediatric Mandibular Central Giant Cell Granuloma: Neoadjuvant Immunotherapy to Minimize Surgical Resection. (Pubmed Central) -  Nov 21, 2021   
    Neoadjuvant immunotherapy with denosumab (human monoclonal antibody) facilitated treatment of the tumor without the need for a large resection which would have otherwise necessitated a vascularized bony mandibular reconstruction. Consideration of neoadjuvant medical management of CGCG as the primary treatment is advocated.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Efficacy of Antiosteoporotic Medications in Patients With Rebound-Associated Fractures After Denosumab Discontinuation. (Pubmed Central) -  Nov 21, 2021   
    Three patients sustained additional fractures despite treatment reinstitution (2 with zoledronate and 1 with teriparatide). Among patients with RAVFs following denosumab discontinuation both antiresorptive (zoledronate and denosumab) and anabolic (teriparatide) treatment as well as the combination of denosumab with teriparatide seem to be effective in terms of BMD response.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Transforming non metastatic in metastatic prostate cancer () -  Nov 20, 2021 - Abstract #PROSCABLADDR2021PROSCA_BLADDR_1;    
    We choose to classify the patient as a mCRPC TREATMENT As first line treatment for mCPRC patient we decided to start on Enzalutamide + Denosumab COMMENT In Spartan and Prosper trials the incidence of fractures reaches up to 18%, and Darolutamide is not available in Argentina. With the PET-CT PSMA we “transformed” this patient into a mCPRC one and we could treat him with a better bone protection therapy (denosumab 120 mg every 4 weeks or Zoledrinic ac 4 mg every 4 weeks).
  • ||||||||||  AVT03 (denosumab biosimilar) / Alvotech, Dr. Reddy's
    New P1 trial:  AVT03 With Prolia in Healthy Male Subjects (clinicaltrials.gov) -  Nov 18, 2021   
    P1,  N=206, Not yet recruiting, 
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Retrospective data, Journal:  Recurrent giant cell tumour of the distal ulna after en bloc resection with preoperative denosumab use. (Pubmed Central) -  Nov 17, 2021   
    There are a few reports of recurrent cases after en bloc resection; however, the association with the use of denosumab is unknown. We present the clinical, radiological and histopathological findings of a case of Campanacci grade III GCTB at the distal end of the ulna, which resulted in soft tissue recurrence after en bloc resection with the preoperative use of denosumab.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  On the effect of antiresorptive drugs on the bone remodeling of the mandible after dental implantation: a mathematical model. (Pubmed Central) -  Nov 17, 2021   
    We show that using antiresorptive agents such as bisphosphonates or denosumab increases bone density and the associated mechanical properties, but at the same time, it also increases bone brittleness. We conclude that, despite the many limitations of these very complex models, the one presented here is capable of predicting qualitatively the evolution of some of the main biological and chemical variables associated with the process of bone remodeling in patients receiving drugs for osteoporosis, so it could be used to optimize dental implant design and coating for osteoporotic patients, as well as the drug dosage protocol for patient-specific treatments.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Retrospective data, Review, Journal:  Denosumab is not associated with risk of malignancy: systematic review and meta-analysis of randomized controlled trials. (Pubmed Central) -  Nov 16, 2021   
    We conclude that, despite the many limitations of these very complex models, the one presented here is capable of predicting qualitatively the evolution of some of the main biological and chemical variables associated with the process of bone remodeling in patients receiving drugs for osteoporosis, so it could be used to optimize dental implant design and coating for osteoporotic patients, as well as the drug dosage protocol for patient-specific treatments. No abstract available