Prolia (denosumab) / Amgen 
Welcome,         Profile    Billing    Logout  
 110 Diseases   151 Trials   151 Trials   7120 News 


«12...4546474849505152535455...8687»
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    [VIRTUAL] Bone modifying agents in veterans with castration-resistant prostate cancer. () -  Apr 28, 2021 - Abstract #ASCO2021ASCO_3124;    
    Patients who are older, had more comorbidities, or were Black were less likely to receive a BMA after starting treatment for CRPC . Understanding factors that lead to different patterns of treatment can guide initiatives toward more guideline-concordant care.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Xofigo (radium Ra-223 dichloride) / Bayer
    [VIRTUAL] Radium-223 (Ra-223) versus novel antihormone therapy (NAH) for progressive metastatic castration-resistant prostate cancer (mCRPC) after 1 line of NAH: RADIANT, an international phase 4, randomized, open-label study. () -  Apr 28, 2021 - Abstract #ASCO2021ASCO_2839;    
    P4
    As life-prolonging therapy is increasingly used in hormone-sensitive settings, this study has been designed to assess Ra-223 outcomes in patients with mCRPC that progressed after prior treatment with NAH and docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC) or mCRPC...Patients are randomized 1:1 to Ra-223 or NAH: Ra-223 55 kBq/kg intravenously every 4 weeks for 6 cycles or until disease progression, death, or withdrawal of consent if earlier; or abiraterone 1000 mg + prednisone 10 mg daily (if prior enzalutamide) or enzalutamide 160 mg daily (if prior abiraterone) until disease progression, death, or withdrawal of consent...Patients must use luteinizing hormone-releasing hormone analogs, if not surgically castrated, and bone health agents (bisphosphonates or denosumab) throughout the study...The expected study duration is 55 months, with a target of 696 patients to be randomized . The first patient was enrolled on November 9, 2020; 5 patients have been randomized and 2 have started treatment to date.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Journal:  Denosumab Treatment for Giant Cell Tumor of the Spine Including the Sacrum. (Pubmed Central) -  Apr 28, 2021   
    P2
    Results from the analysis suggest that denosumab is potentially effective treatment for patients with GCTB of the spine including the sacrum. The adverse event profile was consistent with the full study population.Level of Evidence: 2.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
    Journal:  Romosozumab : a new treatment for severe osteoporosis (Pubmed Central) -  Apr 28, 2021   
    The increase in bone mineral density is higher with romosozumab as compared to teriparatide in patients previously treated with alendronate. The use of romosozumab (Evenity) is admitted for patients with high risk of fractures but without serious vascular events.
  • ||||||||||  CMAB807 (denosumab biosimilar) / 3SBio
    Enrollment open:  Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia (clinicaltrials.gov) -  Apr 27, 2021   
    P3,  N=278, Recruiting, 
    Moreover, biochemical markers data indicate that osteoporotic patients, without other concomitant unstable health conditions, could be evaluated once a year, decreasing the number of specialistic center access. Not yet recruiting --> Recruiting
  • ||||||||||  Boyoubei (denosumab biosimilar) / Luye Group
    New P3 trial:  Efficacy and Safety of LY01011 and Xgeva (clinicaltrials.gov) -  Apr 25, 2021   
    P3,  N=850, Not yet recruiting, 
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Journal:  The role of M1 and M2 macrophage polarization in progression of medication-related osteonecrosis of the jaw. (Pubmed Central) -  Apr 24, 2021   
    This review article outlines the most current evidence-based medicine with regard to considerations in spine surgery of the osteoporotic patient, and aims to bring about new questions to be investigated in that paradigm. Therapeutic molecules targeting the inflammatory microenvironment via the regulation of either M1 or M2 macrophage polarization may represent a novel strategy for treatment of MRONJ.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Trial completion date, Trial primary completion date:  MiDeTe - microRNA Levels Under Denosumab and Teriparatide Therapy in Postmenopausal Osteoporosis (clinicaltrials.gov) -  Apr 22, 2021   
    P4,  N=80, Active, not recruiting, 
    Despite promising results, the incorporation of denosumab in preventive and therapeutic protocols of breast cancer beyond prevention of SREs cannot be endorsed until further research consolidates its efficacy. Trial completion date: Dec 2020 --> Sep 2021 | Trial primary completion date: Dec 2020 --> Jun 2021
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Clinical, Journal:  Persistence with oral bisphosphonates and denosumab among older adults in primary care in Ireland. (Pubmed Central) -  Apr 22, 2021   
    Free access to GP services and medications may have resulted in better medication persistence in this cohort. Future research should explore prescribing choices in primary care osteoporosis management and evaluate cost-effectiveness of interventions for improving persistence.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    [VIRTUAL] TREATMENT OF OSTEOCLAST BONE DYSPLASIAS WITH DENOSUMAB () -  Apr 14, 2021 - Abstract #ASPHO2021ASPHO_444;    
    We present six patients with osteoclast bone dysplasias successfully treated with denosumab who had 100% disease control rate, bone sclerosis and symptomatic improvement. Careful observation of younger patients for rebound hypercalcemia after completion of therapy is warranted.
  • ||||||||||  Prolia (denosumab) / Amgen
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  DenosuMast: Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis (clinicaltrials.gov) -  Apr 14, 2021   
    P3,  N=24, Active, not recruiting, 
    No abstract available Recruiting --> Active, not recruiting | N=90 --> 24 | Trial completion date: Mar 2024 --> Nov 2023 | Trial primary completion date: Mar 2024 --> Nov 2023
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    [VIRTUAL] Patient-Reported Outcomes in Commercial Pediatric Oncology Clinical Trials () -  Apr 12, 2021 - Abstract #ISPOR2021ISPOR_562;    
    When used, PRO data were often limited by lack of a clear prospective statistical analysis plan, high levels of missing data, and use of instruments that were not fit-for-purpose. 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 AEs and complement standard clinician-reported safety data in pediatric oncology trials.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
    [VIRTUAL] Are Multiple Brands Used to Charge Higher Prices for Orphan Drug Designations in the US? () -  Apr 12, 2021 - Abstract #ISPOR2021ISPOR_257;    
    For one month of treatment, the ratios of prices between orphan and non-orphan indications were: 11.163 for denosumab, 7.724 for everolimus, 2.707 for hydroxyurea, 2.683 for peginterferon alfa-2b, 1.062 for cabozantinib, and 0.930 for tolvaptan (ratios >1 indicate higher cost for the orphan indication)...CONCLUSIONS While certain drugs are significantly more expensive when used in an orphan indication, others do not follow this same pattern. Further research is needed to explore additional drug databases in the US and other countries.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Clinical, Journal:  The effect of denosumab in breast cancer patients receiving adjuvant aromatase inhibitors: 36-month results. (Pubmed Central) -  Apr 10, 2021   
    Low serum calcium, use of chemotherapeutic agents, and use of denosumab might contribute to the development of ARONJ. Twice-yearly administration of denosumab to the breast cancer patients treated with adjuvant AI, regardless of the skeletal site, resulted in consistent increases in BMD without severe adverse events at 36 months.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
    Clinical, Journal:  Romosozumab followed by denosumab in Japanese women with high fracture risk in the FRAME trial. (Pubmed Central) -  Apr 10, 2021   
    Twice-yearly administration of denosumab to the breast cancer patients treated with adjuvant AI, regardless of the skeletal site, resulted in consistent increases in BMD without severe adverse events at 36 months. Romosozumab/denosumab in Japanese subjects at high risk of fracture resulted in significant BMD gains and numerically lower vertebral fracture rate vs. placebo/denosumab at all timepoints measured.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Response to Denosumab in 2 Children With Recurrent Giant Cell Tumor of the Bone With Pulmonary Metastasis. (Pubmed Central) -  Apr 7, 2021   
    Denosumab, a fully human monoclonal antibody against RANKL (receptor activator of nuclear factor κB ligand), is approved for the treatment of unresectable GCTB in skeletally mature individuals. We present a case series of 2 pediatric patients with recurrent GCTB with pulmonary metastasis, with clinical response to denosumab therapy.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Journal:  Letter to the Editor: might denosumab fit in PBC treatment? (Pubmed Central) -  Apr 7, 2021   
    PBC is a chronic cholestatic liver disease characterized by progressive destruction of intrahepatic bile ducts, portal tract inflammation, and fibrosis that may eventually progress to end-stage liver disease (2). Even though the exact etiology of PBC remains unknown, it is extensively accepted that the development of PBC requires one or more environmental factors that initiate an autoimmune response in genetically predisposed individuals.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Review, Journal:  Schemes for Drug-Induced Treatment of Osteonecrosis of Jaws with Particular Emphasis on the Influence of Vitamin D on Therapeutic Effects. (Pubmed Central) -  Apr 7, 2021   
    In this article, the most important issues related to the treatment of drug-induced osteonecrosis of the jaws (ONJ) are raised, including medication-related osteonecrosis of the jaw (MRONJ); conservative treatment, including the use of laser; and the impact of vitamin D supplementation on the overall treatment, prognosis, and prevention before complication, which is osteonecrosis of the jaw in the course of treatment with bisphosphonates and other drugs predisposing to MRONJ, such as denosumab and angiogenesis inhibitors...Surgical treatment of advanced stages is complicated and carries a high risk of error and complications. MRONJ is a disease that is easy to avoid, but it is difficult to treat and treatment sometimes leads only to a partial remission of the disease, not a complete cure.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Review, Journal:  The Impact of Antiosteoporotic Drugs on Glucose Metabolism and Fracture Risk in Diabetes: Good or Bad News? (Pubmed Central) -  Apr 7, 2021   
    Moreover, there are insufficient data to clarify whether there are any differences in the efficacy of antiosteoporotic drugs on fracture incidence between diabetic and nondiabetic patients with osteoporosis. Although more studies are required for stronger recommendations to be issued, bisphosphonates appear to be the first-line drug for treatment of osteoporosis in diabetic patients, while denosumab seems preferable for older patients, particularly for those with impaired renal function, and osteoanabolic agents should be reserved for patients with more severe forms of osteoporosis.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Clinical, Journal, HEOR:  Effectiveness of Rehabilitative Intervention on Pain, Postural Balance, and Quality of Life in Women with Multiple Vertebral Fragility Fractures: A Prospective Cohort Study. (Pubmed Central) -  Apr 7, 2021   
    The aim of our longitudinal cohort study is to evaluate the effectiveness of rehabilitation, including postural training, resistance exercises, and visual stabilization exercises, for a 7-week period, on the pain, postural balance, and QoL of subjects with at least two vertebral fragility fractures receiving denosumab and vitamin D. We investigated, before (T0) and after (T1, at 7 weeks) rehabilitation, the following outcome measures on 28 patients: pain (Numerical Rating Scale (NRS)), self-perceived QoL (36-Item Short Form Survey (SF-36) and Mini-Osteoporosis Quality of Life Questionnaire (Mini-OQOL)), dizziness (Dizziness Handicap Inventory (DHI-I)), mobility (Timed-Up and Go (TUG) test), and instrumental posturographic assessment (FreeMed posturography system)...Moreover, a significant functional improvement (TUG test) was found in those with two vertebral fractures, without any statistically significant change reported for other outcomes. Our findings suggest that combined intervention, including anti-osteoporotic drugs and postural rehabilitation, should be proposed to osteoporotic patients with multiple vertebral fractures.