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


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  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Dupixent (dupilumab) / Sanofi, Regeneron
    Economic Results Generated By Optimizing a Parenteral Medication Application Process () -  Mar 9, 2023 - Abstract #ISPOR2023ISPOR_1032;    
    The incidence of adverse drug reactions was in line with expectations from previous studies, osteonecrosis of the jaw did not occur in any of the patients involved in the study. The Priori strategy generates greater timeliness in the administration of the drug after its prescription, avoiding the patient having to take administrative steps to access drug therapy and therefore better health outcomes.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Impact of Long-Acting Modality on Health Technology Assessments and Formulary Decision Making in the EU4 and USA () -  Mar 9, 2023 - Abstract #ISPOR2023ISPOR_379;    
    Payers cite Prolia (Densosumab), which is administered once every six months for postmenopausal osteoporosis in women who are at an increased risk of fractures, as an example... While the long-acting modality is an important benefit at the patient and prescriber level to achieve a relatively higher uptake/adherence, Payers and HTA bodies look beyond the long-acting mechanism to assess the therapeutic benefit, HTA rating, and pricing/reimbursement status of a novel therapy
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Denosumab treatment for progressive Enneking stage II cervical giant-cell tumor conservatively. (Pubmed Central) -  Mar 7, 2023   
    To date, this is the youngest patient ever reported to have a progressive Enneking stage II C3 GCTB treated with denosumab alone. Denosumab can be administered as a single and conservative therapy for pediatric patients with unresectable upper cervical GCTB, avoiding the risks and morbidity of surgical and radiative treatment.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal, BRCA Biomarker:  Differences between zoledronic acid and denosumab for breast cancer treatment. (Pubmed Central) -  Mar 7, 2023   
    Although denosumab's anticancer activity has not been clearly proven compared with zoledronic acid's anticancer activity, denosumab is promising in preventing BRCA1 mutant breast cancer because RANKL is a targetable pathway in BRCA1-associated tumorigenesis. Further studies and more effective clinical use of these agents are anticipated to contribute to the improvement of the clinical outcome of breast cancer patients.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  RANKL and RANK in Cancer Therapy. (Pubmed Central) -  Mar 4, 2023   
    Receptor activator of nuclear factor-kB (RANK) and its ligand (RANKL) have been described as key regulators in mammalian physiology such as bone metabolism, immune system, mammary gland biology or cancer. Herein, we explore the multiple functions of the RANKL/RANK pathway in physiology and pathophysiology and discuss the underlying principles and strategies to modulate the RANKL/RANK pathway as a therapeutic target in immune-mediated cancer treatment.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
    Journal:  Monoclonal antibodies for treatment of osteoporosis. (Pubmed Central) -  Mar 3, 2023   
    Denosumab is a fully human monoclonal antibody IgG2 isotype that binds RANK ligand (RANKL) and prevents the interaction of RANKL with its receptor RANK. Denosumab is an antiresorptive that has been used for more than a decade, and romosozumab has recently been approved for clinical practice worldwide.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion date, Trial primary completion date:  Study of XGEVA (clinicaltrials.gov) -  Mar 3, 2023   
    P4,  N=35, Not yet recruiting, 
    In postmenopausal women with osteoporosis, up to 10 years of denosumab significantly and continuously improved bone microarchitecture assessed by TBS, independently of BMD, and shifted more patients to lower fracture-risk categories. Trial completion date: Oct 2027 --> Jul 2027 | Trial primary completion date: Oct 2027 --> Jun 2027
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
    Clinical guideline, Journal:  Pharmacologic Treatment of Primary Osteoporosis or Low Bone Mass to Prevent Fractures in Adults: A Living Clinical Guideline From the American College of Physicians. (Pubmed Central) -  Feb 27, 2023   
    ACP suggests that clinicians use the sclerostin inhibitor (romosozumab, moderate-certainty evidence) or recombinant PTH (teriparatide, low-certainty evidence), followed by a bisphosphonate, to reduce the risk of fractures only in females with primary osteoporosis with very high risk of fracture (conditional recommendation). ACP suggests that clinicians take an individualized approach regarding whether to start pharmacologic treatment with a bisphosphonate in females over the age of 65 with low bone mass (osteopenia) to reduce the risk of fractures (conditional recommendation; low-certainty evidence).
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Giant cell tumor of bone: An update, including spectrum of pathological features, pathogenesis, molecular profile and the differential diagnoses. (Pubmed Central) -  Feb 27, 2023   
    Lately, a specific Histone mutation, namely H3.3G34W underlying almost all GCTBs has been discovered, further leading to the identification of a highly sensitive and specific immunohistochemical antibody marker, H3.3G34W, which is very useful for an exact diagnosis of a GCTB, including its differentiation from its various mimics, which has significant implications. This review describes clinicopathological features of a GCTB, including its variable features, recent concepts, underlying pathogenesis, post-denosumab related changes and various entities that constitute its differential diagnosis, including their molecular signatures, with treatment-related implications.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Outcome of healing after dental implant placement in patients with cancer on high-dose antiresorptive medications: a prospective feasibility study. (Pubmed Central) -  Feb 27, 2023   
    P=N/A
    This review describes clinicopathological features of a GCTB, including its variable features, recent concepts, underlying pathogenesis, post-denosumab related changes and various entities that constitute its differential diagnosis, including their molecular signatures, with treatment-related implications. This study demonstrated that it is feasible to insert dental implants and perform an abutment surgery in patients with cancer on HDAR, without the development of MRONJ.
  • ||||||||||  Clinical, Journal:  Age is just a number: the concept of time to benefit in older adults. (Pubmed Central) -  Feb 27, 2023   
    This case report illustrates that both mortality risk assessment and evaluation of the time to benefit should be part of any medication review in frail older adults. Conversely, with limited available data pertaining to the concept of time to benefit, we advocate a broader awareness among pharmacists and a systematic assessment in future clinical trials.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Role of denosumab in bone erosions in rheumatoid arthritis. (Pubmed Central) -  Feb 26, 2023   
    Denosumab, a fully human monoclonal antibody, binds RANK-L and suppresses the RANK-RANK-L signaling pathway leading to the inhibition of osteoclastogenesis. A retrospective analysis of published studies such as clinical trials evidenced the efficacy of denosumab in preventing bone erosion progression in RA patients.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Mailishu (denosumab biosimilar) / Mabwell (Shanghai) Biosci, Binnopharm
    Trial completion:  Efficacy and Safety of MW032 and Xgeva (clinicaltrials.gov) -  Feb 24, 2023   
    P3,  N=708, Completed, 
    Denosumab therapy can play a critical role in managing such patients especially when other therapeutic modalities cannot adequately control hypercalcaemia. Active, not recruiting --> Completed
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Trial completion date, Trial primary completion date:  Denosumab vs Alendronate After Vertebroplasty (clinicaltrials.gov) -  Feb 21, 2023   
    P=N/A,  N=90, Recruiting, 
    Active, not recruiting --> Completed Trial completion date: Jan 2023 --> Oct 2023 | Trial primary completion date: Jan 2023 --> Sep 2023
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Trial completion date, Trial primary completion date:  Denosumab vs Zoledronic Acid and Osteoporotic Compression Fracture (clinicaltrials.gov) -  Feb 21, 2023   
    P2/3,  N=122, Recruiting, 
    Trial completion date: Jan 2023 --> Oct 2023 | Trial primary completion date: Jan 2023 --> Sep 2023 Trial completion date: Oct 2022 --> Mar 2023 | Trial primary completion date: Sep 2022 --> Mar 2023
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Trial completion date, Trial primary completion date:  Denosumab and Screw Fixation for Osteoporotic Compression Fracture (clinicaltrials.gov) -  Feb 21, 2023   
    P2/3,  N=125, Recruiting, 
    Trial completion date: Oct 2022 --> Mar 2023 | Trial primary completion date: Sep 2022 --> Mar 2023 Trial completion date: Sep 2022 --> Sep 2023 | Trial primary completion date: Mar 2022 --> Mar 2023
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Enrollment open:  MITO: Muscle Impact of Treating Osteoporosis (clinicaltrials.gov) -  Feb 21, 2023   
    P4,  N=40, Recruiting, 
    Trial completion date: Sep 2022 --> Sep 2023 | Trial primary completion date: Mar 2022 --> Mar 2023 Not yet recruiting --> Recruiting
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Avastin (bevacizumab) / Roche, Herceptin (trastuzumab) / Roche
    UNPREDICTABLE EVOLUTION OF LOCALIZED TRIPLE-NEGATIVE BREAST CANCER IN A YOUNG 36-YEAR-OLD PATIENT () -  Feb 19, 2023 - Abstract #BGICC2023BGICC_458;    
    Recruiting --> Active, not recruiting First-line metastatic Taxotere/Trastuzumab/denosumab type chemotherapy; After CT4: more than 80% response to breast MRI Laterocervical adenopathy at CT10.Cervical biopsy: metastatic extension at the level of the muscle of mammary origin RH(-) Her (-) Ki67: 70%.CT scan: appearance of hepatic nodules; 2nd line chemotherapy was administered, such as Bevacizumab
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Bone mineral density response to antiosteoporotic drugs in older depressed adults. (Pubmed Central) -  Feb 13, 2023   
    Our study has shown that the presence of depression and/or serotonergic antidepressant use was associated with non-response to osteoporosis treatment in older adults. The results of our study may guide physicians to make treatment decisions in older individuals with depression.