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


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  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Antibody characterization using novel ERLIC-MS/MS-based peptide mapping. (Pubmed Central) -  Jun 9, 2019   
    ...Here, we describe a novel ERLIC-MS/MS-based peptide mapping method that was successfully used for the characterization of denosumab, in particular the analysis of sequence coverage, terminal peptides, methionine oxidation, asparagine deamidation and glycopeptides...This study extends the applications of ERLIC from that of a trapping/fractioning column to biologic therapeutics characterization. The ERLIC-MS/MS method can enhance biologic therapeutics analysis with more reliability and confidence for bottom-up peptide mapping-based characterization.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Journal, Circulating Tumor Cells:  Denosumab treatment is associated with the absence of circulating tumor cells in patients with breast cancer. (Pubmed Central) -  Jun 7, 2019   
    In addition to blood count correlatives to single and clustered CTCs, we found that denosumab treatment associates with most patients lacking CTCs from their peripheral circulation. Prospective studies will be needed to validate the involvement of denosumab in the prevention of CTC generation.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  ACE Gene Variant Causing High Blood Pressure May Be Associated With Medication-related Jaw Osteonecrosis. (Pubmed Central) -  Jun 6, 2019   
    ...The second patient, a 65 years old woman, took denosumab, 120 mg subcutaneously once per month for 6 months for possible bone metastases from breast cancer...He also presented with hypertension and genetic testing revealed that she had the high blood pressure D variant of the ACE gene in a heterozygous state, which moderately predisposes to hypertension. To our knowledge, this is the first report indicating that genetic predisposition to hypertension may increase risk for MRONJ.
  • ||||||||||  abaloparatide (BA058) / Radius
    Clinical, Journal:  Efficacy and safety of abaloparatide for the treatment of post-menopausal osteoporosis. (Pubmed Central) -  Jun 6, 2019   
    These results, together with a reduced prevalence of hypercalcemia and a lower cost of the marketed compound, point toward improved cost effectiveness with abaloparatide versus teriparatide. However, some concerns have been raised due to a somewhat higher occurrence of adverse effects (particularly with palpitations and increased heart rate) or the resultant discontinuation due to these adverse effects when compared to teriparatide.
  • ||||||||||  Prolia (denosumab) / Amgen
    Biomarker, Trial completion, Trial completion date, Trial primary completion date:  RANKL Inhibition and Breast Tissue Biomarkers (clinicaltrials.gov) -  Jun 6, 2019   
    P1,  N=10, Completed, 
    No abstract available Recruiting --> Completed | Trial completion date: May 2019 --> Dec 2018 | Trial primary completion date: May 2019 --> Dec 2018
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial initiation date:  DEFENCE: Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients (clinicaltrials.gov) -  May 30, 2019   
    P2,  N=164, Not yet recruiting, 
    Recruiting --> Completed | Trial completion date: May 2019 --> Dec 2018 | Trial primary completion date: May 2019 --> Dec 2018 Initiation date: Jan 2019 --> Jun 2019
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Fosrenol (lanthanum carbonate) / Takeda, Evomate (raloxifene hydrochloride) / Shreya Life Sciences
    Journal:  Mineral and bone disorders in conventional hemodialysis: Challenges and solutions. (Pubmed Central) -  May 29, 2019   
    ...Many drugs used in the treatment of osteoporosis, including bisphosphonate, raloxifene, denosumab, and teriparatide can, under specific conditions, increase bone mineral density (BMD), which is associated with a lower fracture rate...Some clinical studies have shown that cinacalcet, lanthanum carbonate, and sevelamer reduce mortality in elderly patients on HD, suggesting the benefits of reducing PTH and serum phosphate levels...This is also the case when treating low PTH levels by decreasing vitamin D or calcium load. RCTs with hard clinical endpoints comparing different targets are necessary in the future.
  • ||||||||||  abaloparatide (BA058) / Radius, Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Long-term treatment strategies for postmenopausal osteoporosis. (Pubmed Central) -  May 29, 2019   
    RCTs with hard clinical endpoints comparing different targets are necessary in the future. Optimal sequential monotherapy, over an average of 30 postmenopausal years, should be able to minimize exposure to pharmacology while maximizing benefits on bone strength and minimizing imminent and long-term risk of fracture.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion date, Trial primary completion date:  A Study of Denosumab in Multiple Myeloma Patients with Renal Insufficiency (clinicaltrials.gov) -  May 28, 2019   
    P2,  N=55, Recruiting, 
    This pilot study provides evidence that lumbar spine BSV as obtained from conventional radiographs constitutes a useful means for the assessment of bone-specific treatment effects in postmenopausal women with osteoporosis. Trial completion date: Oct 2023 --> Oct 2022 | Trial primary completion date: Oct 2019 --> Oct 2020
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Review, Journal:  Roles of the RANKL-RANK axis in antitumour immunity - implications for therapy. (Pubmed Central) -  May 24, 2019   
    We highlight the role of immune cells as sources of RANK and RANKL in the tumour microenvironment and review data on RANKL inhibition in mouse models of cancer. Finally, we describe hypothetical immune-related mechanisms of action, which could be assessed in clinical trials of immune-checkpoint inhibitors and denosumab in patients with cancer.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Severe osteoporosis: Principles for pharmacological therapy in mexico. (Pubmed Central) -  May 23, 2019   
    The results of this review can therefore be used to formulate clinical studies more precisely in order to standardise and focus on patient-relevant outcomes. Our results agree with the recommendations available in national and international clinical practice guidelines, with both therapies proposed as a sequential, but not a substitute, treatment.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Edirol (eldecalcitol) / Roche, Taisho
    Journal:  Body weight and bone/calcium metabolism. Bone and calcium metabolism in anorexia nervosa. (Pubmed Central) -  May 17, 2019   
    Eldecalcitol of 0.5μg/day shows about 5%increase in lumbar vertebrae BMD in first year. Bisphosphonate and a RANK ligand inhibitors, denosumab should not be used for young patients and women in hope of the pregnancy.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Review, Journal:  Hypercalcemia of Malignancy. (Pubmed Central) -  May 16, 2019   
    ...Management options include aggressive hydration, bisphosphonates, denosumab, calcitonin, and corticosteroids...It is also important for continuous monitoring to occur alongside treatment for HCM to prevent potential adverse effects. Finally, the ultimate resolution of HCM comes only from the treatment of the underlying malignancy; therefore, all previously undiagnosed patients should be referred to an oncologist early after HCM is recognized.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, P3 data, Journal:  A randomized phase III trial of denosumab before curettage for giant cell tumor of bone: Japan Clinical Oncology Group Study JCOG1610. (Pubmed Central) -  May 15, 2019   
    Secondary endpoints include overall survival, joint-preserved survival, local RFS, metastasis-free survival, adverse events, serious adverse events, surgical and postoperative complications, and discontinuation of denosumab. This trial is conducted by the Bone and Soft Tissue Tumor Study Group in the Japan Clinical Oncology Group and has been registered in the UMIN Clinical Trials Registry as UMIN000029451 [http://www.umin.ac.jp/ctr/index.htm].
  • ||||||||||  Xtandi (enzalutamide) / Pfizer, Astellas, Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Zytiga (abiraterone acetate) / J&J
    Clinical, Review, Journal:  Bone Health Issues in Patients with Prostate Cancer: An Evidence-Based Review. (Pubmed Central) -  May 14, 2019   
    Bone targeted drugs have become standard of care in patients with metastatic castration resistant prostate cancer, their role in metastatic hormone sensitive prostate cancer has been discussed controversely. In oligometastatic prostate cancer patients several promising approaches in metastasis directed therapy, including conventional surgery, stereotactic ablative radiation and image-guided single-fraction robotic stereotactic radiosurgery (CyberKnife®) were launched but are not in routine clinical use until now caused by sparse clinical evidence.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Fortuitous administration of denosumab in breast carcinoma with osteoclastic giant cells. (Pubmed Central) -  May 9, 2019   
    To the best of our knowledge, this is the first report of breast cancer with OGCs occurring initially in a metastasis while absent in the original tumor and the first description of its successful treatment with denosumab. This case sheds light on the development of giant cells in the tumor microenvironment and suggests the potential use of denosumab in the management of cancers with giant cell elements.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Journal:  Clinical improvement in a patient with monostotic melorheostosis after treatment with denosumab: a case report. (Pubmed Central) -  May 9, 2019   
    This case sheds light on the development of giant cells in the tumor microenvironment and suggests the potential use of denosumab in the management of cancers with giant cell elements. This is the first report indicating that denosumab has a place in the treatment of melorheostosis when the effect of bisphosphonate treatment is insufficient.
  • ||||||||||  Rituxan (rituximab) / Roche, Biogen
    Review, Journal:  Osteoporosis in Rheumatic Diseases: Anti-rheumatic Drugs and the Skeleton. (Pubmed Central) -  May 8, 2019   
    Medications that are approved for the treatment of osteoporosis have been evaluated to prevent bone loss in rheumatic disease patients, including denosumab, cathepsin K, bisphosphonates, anti-sclerostin antibodies and parathyroid hormone (hPTH 1-34), and have some efficacy in both the prevention of systemic bone loss and reducing localized bone erosions. This article reviews the effects of biologic DMARDs on bone mass and erosions in patients with rheumatic diseases and trials of anti-osteoporotic medications in animal models and patients with rheumatic diseases.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Retrospective data, Journal:  The impact of switching once-weekly teriparatide to denosumab in osteoporosis patients. (Pubmed Central) -  May 8, 2019   
    BMD significantly increased in osteoporosis patients switched from w-TPTD to DMAb. However, the impact of switching from w-TPTD to DMAb in secondary osteoporosis patients was not as great as in primary osteoporosis patients at the view points of changes in BMD of FN and TH.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Edirol (eldecalcitol) / Roche, Taisho
    Journal:  Potential association with early changes in serum calcium level after starting or switching to denosumab combined with eldecalcitol. (Pubmed Central) -  May 7, 2019   
    Therefore, appropriate assessment before administration of DMAb, including pretreatment therapy as well as serum Ca and bone metabolic markers will help identify the risk of hypocalcemia following DMAb in combination with eldecalcitol. Our findings also showed that early change in serum Ca level after DMAb initiation could potentially predict the efficacy for therapy reaction.
  • ||||||||||  Avastin (bevacizumab) / Roche
    Journal:  Progress on medication-related osteonecrosis of the jaw (Pubmed Central) -  May 7, 2019   
    In addition to BPs, several antiresorptive and antiangiogenic agents, such as denosumab and bevacizumab, as well as targeted agents, such as sunitinib and temsirolimus, can cause osteonecrosis of  the  jaw according to the literature. This review aims to summarize the research progress on these new drugs.
  • ||||||||||  abaloparatide (BA058) / Radius, Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
    Review, Journal:  Molecular understanding of pharmacological treatment of osteoporosis. (Pubmed Central) -  May 7, 2019   
    Cite this article: EFORT Open Rev 2019;4:158-164. DOI: 10.1302/2058-5241.4.180018.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion date, Trial primary completion date:  Denosumab Safety Assessment in Multiple Observational Databases (clinicaltrials.gov) -  May 3, 2019   
    P=N/A,  N=508215, Active, not recruiting, 
    DOI: 10.1302/2058-5241.4.180018. Trial completion date: May 2020 --> Jun 2023 | Trial primary completion date: May 2020 --> Jun 2023
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB, Actonel (risedronate) / Sanofi
    Journal:  Osteoporosis (Pubmed Central) -  Apr 30, 2019   
    Atypical femoral fractures associated with bisphosphonate treatment could be more frequent in patients with particular anatomical features. Management of osteoporosis treatment depends on the drug which is used and on the risk of fracture of the patient.
  • ||||||||||  Zinbryta (daclizumab) / Biogen, AbbVie
    Journal, Adverse events:  Pharmacovigilance update (Pubmed Central) -  Apr 30, 2019   
    Voriconazole: cutaneous squamous cell carcinoma under long-term therapy. Proton pump inhibitors : early exposure might increase fracture risk in young children.