Prolia (denosumab) / Amgen 
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  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    [VIRTUAL] Locally advanced GCTB recurrence after neoadjuvant denosumab use. () -  Apr 29, 2020 - Abstract #ASCO2020ASCO_5843;    
    Neoadjuvant denosumab for GCTB provides promising results, with acceptable recurrence rates, as well as a less aggressive approach, with lower risk of morbidity or sequelae and excellent safety profile. Research Funding: None
  • ||||||||||  [VIRTUAL] Establishment of a primary cell culture of bone metastasis from urothelial carcinoma. () -  Apr 29, 2020 - Abstract #ASCO2020ASCO_4311;    
    This system can recreate microenvironmental conditions more similar to in-vivo ones and it promoted the isolation of tumor cell clones from stromal components of the heterogeneous primary culture. This cell line could be useful to investigate the molecular and genetic profile in order to identify promising molecular targets and to better understard the natural history of BM from UC.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg.
    [VIRTUAL] Multicenter Italian bone metastasis database: First prospective data on breast cancer patients. () -  Apr 29, 2020 - Abstract #ASCO2020ASCO_2934;    
    This study presents prospective data about a cohort of BC pts enrolled at the first BM occurrence and followed over the time, extrapolated by the multicentric observational BMDB in order to better understed the clinical history of breast cancer and bone metastases. Research Funding: None
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Protein Expression Profiles Corresponding to Histological Changes with Denosumab Treatment in Giant Cell Tumors of Bone. (Pubmed Central) -  Apr 29, 2020   
    While invasive OPEs were common in these denosumab-treated women and were associated with an increased ONJ incidence, the overall rate of ONJ was low, and all cases with complete follow-up resolved with treatment. We believe that the identified proteins and the results of the network analysis will provide a better understanding of the effects of denosumab in GCTB.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  A Novel, Tumor-Induced Osteoclastogenesis Pathway Insensitive to Denosumab but Interfered by Cannabidiol. (Pubmed Central) -  Apr 26, 2020   
    Osteoclastogenesis and its interference by cannabidiol were independent of the expression of nuclear factor of T cell c1 (NFATc1). These results show that osteoclastogenesis induced by OSCC cells targeting OPCs is a novel osteoclastogenic pathway independent of NFATc1 expression that is partially caused by tumor-derived exosomes and suppressed by cannabidiol.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Trial initiation date:  Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI (clinicaltrials.gov) -  Apr 23, 2020   
    P2,  N=39, Not yet recruiting, 
    These results show that osteoclastogenesis induced by OSCC cells targeting OPCs is a novel osteoclastogenic pathway independent of NFATc1 expression that is partially caused by tumor-derived exosomes and suppressed by cannabidiol. Initiation date: Feb 2020 --> Oct 2020
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Identification of osteoclast-osteoblast coupling factors in humans reveals links between bone and energy metabolism. (Pubmed Central) -  Apr 21, 2020   
    Based on these analyses, LIF, CREG2, CST3, CCBE1, and DPP4 are likely osteoclast-derived coupling factors in humans. Given the role of Dipeptidyl Peptidase-4 (DPP4) in glucose homeostasis, we further demonstrate that DMAb-treated participants have a significant reduction in circulating DPP4 and increase in Glucagon-like peptide (GLP)-1 levels as compared to the placebo-treated group, and also that type 2 diabetic patients treated with DMAb show significant reductions in HbA1c as compared to patients treated either with bisphosphonates or calcium and vitamin D. Thus, our results identify several coupling factors in humans and uncover osteoclast-derived DPP4 as a potential link between bone remodeling and energy metabolism.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial suspension:  PROUD: Preventing Osteoporosis Using Denosumab (clinicaltrials.gov) -  Apr 20, 2020   
    P4,  N=212, Suspended, 
    Given the role of Dipeptidyl Peptidase-4 (DPP4) in glucose homeostasis, we further demonstrate that DMAb-treated participants have a significant reduction in circulating DPP4 and increase in Glucagon-like peptide (GLP)-1 levels as compared to the placebo-treated group, and also that type 2 diabetic patients treated with DMAb show significant reductions in HbA1c as compared to patients treated either with bisphosphonates or calcium and vitamin D. Thus, our results identify several coupling factors in humans and uncover osteoclast-derived DPP4 as a potential link between bone remodeling and energy metabolism. Recruiting --> Suspended
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Review, Journal:  Clinical and Translational Pharmacological Aspects of the Management of Fibrous Dysplasia of Bone. (Pubmed Central) -  Apr 15, 2020   
    Various drugs have been used to achieve clinical improvement in FD/MAS patients including bisphosphonates and denosumab, however further translational studies are also warranted to address unresolved pathophysiological issues and explore novel pharmacological targets for the management of FD/MAS. In this article, we review literature on the medical treatment of FD/MAS, discuss the unresolved pathophysiological issues and explore novel pharmacological targets for the management of FD/MAS.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Review, Journal:  Antiresorptive Agents' Bone-protective and Adjuvant Effects in Postmenopausal Women with Early Breast Cancer. (Pubmed Central) -  Apr 15, 2020   
    After a course of therapy, stoppage of bisphosphonates yields a persistent antiresorptive effect, whereas discontinuation of denosumab causes a rebound increase in bone resorption markers and a loss of bone mineral density to baseline levels. Whether the potential adjuvant benefits of denosumab are also rapidly lost after drug discontinuation deserves further investigation.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Review, Journal:  Clinical and translational pharmacology of drugs for the prevention and treatment of bone metastases and cancer-induced bone loss. (Pubmed Central) -  Apr 14, 2020   
    These have been successfully mitigated with the development of bone-targeted agents (BTAs; bisphosphonates and denosumab), focused on inhibiting osteoclast activity...In this review, the authors aimed to discuss the role of BTAs in the treatment and prevention of bone metastases, as well as their potential value in preventing cancer treatment-induced bone loss (CTIBL). The review will focus on breast and prostate cancers, with the aim of providing the most relevant clinical data emerging from bench to bedside translational research in the field of cancer-induced bone disease.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB, blosozumab (LY2541546) / Eli Lilly
    Review, Journal:  Pharmacometrics and Systems Pharmacology for Metabolic Bone Diseases. (Pubmed Central) -  Apr 14, 2020   
    This review provides an overview of several M&S approaches ranging from simple pharmacokinetic to integrated pharmacometric and systems pharmacology modeling. Examples are included to illustrate the use of these approaches during the development of several drugs for metabolic bone diseases such as bisphosphonates, denosumab, teriparatide and sclerostin inhibitors (romosozumab and blosozumab).
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Review, Journal:  Integration of denosumab therapy in the management of giant cell tumors of bone. (Pubmed Central) -  Apr 14, 2020   
    Will denosumab be the breakthrough GCTB treatment? Here, we provide a pertinent case example, a review of the literature regarding the history and basic science behind the use of denosumab for GCTB, highlight the newest insights into the dosing and duration of treatment, and note advancements in the field.
  • ||||||||||  MSC-1 / Northern biologics
    [VIRTUAL] Phase 1 dose escalation of MSC-1, a humanized anti-LIF monoclonal antibody, in patients with advanced solid tumors (Virtual Meeting: All Session Times Are U.S. EDT) -  Apr 13, 2020 - Abstract #AACRI2020AACR-I_147;    
    Analysis of paired biopsies collected from matched metastatic lesions supported MSC-1 mediated STAT3 signaling inhibition, stimulatory (M1) to suppressive (M2) macrophage skewing in the majority of paired biopsies evaluated and increased CD8 T-cell infiltration in a subset of samples.Single agent MSC-1 was well tolerated in doses ranged from 75 mg to 1500 mg IV OD in patients with advanced solid tumors, showed promising activity as an anti-cancer therapy, and is Phase 1b/2 ready for combination with other agents. The updated final safety, efficacy, PK, LIF stabilization analyses, and tumor biopsy data will be presented.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Journal:  Effect of denosumab on trabecular bone score in de novo kidney transplant recipients. (Pubmed Central) -  Apr 12, 2020   
    The TBS is a useful additional score of bone health, which may help to better define fracture risk. Treatment with denosumab led to improved trabecular bone texture in de novo KTR in addition to its beneficial effect on BMD.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB, zoledronic acid / Generic mfg.
    Journal:  Clinically Relevant Doses of Sclerostin-Antibody do not Induce Osteonecrosis of the Jaw (ONJ) in Rats with Experimental Periodontitis. (Pubmed Central) -  Apr 10, 2020   
    Antiresorptive agents, such as bisphosphonates and denosumab, are frequently used for the management of osteoporosis...In clinical trials, a sclerostin antibody (romosozumab, Amgen Inc., UCB Brussels) increases bone formation and lowers the risk of osteoporotic fractures...Beginning 8 weeks post-ovariectomy, rats were treated for 22 weeks with weekly injections of vehicle (Veh), 200 μg/kg zoledronic acid (ZA), a potent bisphosphonate at 100-fold the osteoporosis dose, or 5 mg/kg sclerostin antibody (Scl-Ab) at the osteoporotic dose...However, these animals presented with no histologic signs of ONJ. In conclusion, sclerostin inhibition enhanced structural bone parameters, without inducing ONJ-like lesions, in ovariectomized rats with EP.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Enrollment change:  Denosumab Treatment for Fibrous Dysplasia (clinicaltrials.gov) -  Apr 8, 2020   
    P2,  N=3, Enrolling by invitation, 
    on behalf of American Society for Bone and Mineral Research. N=14 --> 3
  • ||||||||||  Avastin (bevacizumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS, doxorubicin hydrochloride / Generic mfg.
    EXTENDED SURVIVAL WITH MULTIPLE CYCLES OF SAMARIUM / NIVOLUMAB FOR RELAPSED OSTEOSARCOMA () -  Apr 3, 2020 - Abstract #ASPHO2020ASPHO_141;    
    CASE REPORT: A 13-year-old female with localized OST treated initially with methotrexate, doxorubicin, cis-platinuum, ifosfamide, etoposide experienced 4 relapses in: isolated bone, isolated lung, disseminated lung, disseminated lung,soft tissue and bone, at 9 months, 5 months, 4 months after surgery and systemic therapies (denosumab, gemcitabine/taxotere, zoledronic acid, bevacizumab),respectively. We believe the combination of check point inhibitors and samarium is worthy of further investigation in select patients with OST relapse who have few other options.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion date:  Denosumab In Addition To Intense Urate-Lowering Therapy for Bone Erosions (clinicaltrials.gov) -  Apr 3, 2020   
    P2,  N=20, Recruiting, 
    We believe the combination of check point inhibitors and samarium is worthy of further investigation in select patients with OST relapse who have few other options. Trial completion date: Feb 2020 --> Mar 2021
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Review, Journal:  Management of glucocorticoid-related osteoporotic vertebral fracture. (Pubmed Central) -  Apr 1, 2020   
    Teriparatide and denosumab are alternative options. Percutaneous vertebroplasty and kyphoplasty may be considered for symptomatic control of acute vertebral fracture-related pain when conservative measures fail.