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Journal: Osteoporosis care during the COVID-19 pandemic in the Netherlands: A national survey. (Pubmed Central) - Jan 15, 2021 More than half of the respondents reported a substantial lower quality of osteoporosis care during the COVID pandemic. To prevent an increase in fracture rates and a decrease in patient motivation, adherence and satisfaction, standardization of osteoporosis care delivery in situations of crisis is needed.
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Journal: A Novel Sulforaphane-Regulated Gene Network in Suppression of Breast Cancer-Induced Osteolytic Bone Resorption. (Pubmed Central) - Jan 13, 2021 Oral SFN administration significantly increased the percentage of bone volume/total volume of affected bones in the intracardiac MDA-MB-231-Luc model indicating in vivo suppression of osteolytic bone resorption by SFN. These results indicate that SFN is a novel inhibitor of breast cancer induced osteolytic bone resorption in vitro and in vivo.
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Journal: Chondroblastoma Expresses RANKL by RNA In Situ Hybridization and May Respond to Denosumab Therapy. (Pubmed Central) - Jan 12, 2021 Our results indicate a high proportion of chondroblastomas, GCTs, and aneurysmal bone cysts express RANKL while reactivity in fibrous dysplasia is dependent on the presence of osteoclast-type giant cells. On the basis of the success of denosumab therapy for GCTs, our results indicate that it may be a potential therapeutic option in other primary osseous tumors.
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Trial completion, Trial primary completion date: Circulating Myokine Levels and Bone Metabolism (clinicaltrials.gov) - Jan 12, 2021 P=N/A, N=220, Completed, There are other issues including safety and the launching of new drugs. Recruiting --> Completed | Trial primary completion date: Jun 2020 --> Sep 2020
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Review, Journal: Denosumab Discontinuation and the Rebound Phenomenon: A Narrative Review. (Pubmed Central) - Jan 8, 2021 Therefore, subsequent antiresorptive treatment is mandatory, although the optimal regimen is yet to be clarified. In the present review, we outline what is currently known regarding the negative effects of denosumab discontinuation on different aspects of bone status, the factors that may affect them, and strategies to prevent them.
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[VIRTUAL] Use of bone modifying agents in patients with metastatic castrate-sensitive prostate cancer. () - Jan 8, 2021 - Abstract #ASCOGU2021ASCO_GU_290; In this cohort of mCSPC patients, who were unlikely to have a BMA indication for osteoporotic fracture prevention based on the absence of history of osteoporosis, osteopenia, or fracture, nearly one-quarter received BMAs. The increase in BMA use which occurred during the 2007-2015 study period appears to have been driven by increased utilization of denosumab following its approval in 2010.
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Journal: Dynamics of Bone Cell Interactions and Differential Responses to PTH and Antibody-Based Therapies. (Pubmed Central) - Jan 8, 2021 The main attributes of each disease are qualitatively well captured by the model, for example changes in bone turnover in the disease states. We explored dosing regimens for each disease based on the combination of denosumab and romosozumab, identifying adequate ratios and doses of both drugs for subpopulations of patients in function of categories of osteoporosis and the degree of severity of the disease.
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Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Reduced Dose-density of Denosumab for Unresectable GCTB (clinicaltrials.gov) - Jan 6, 2021 P2, N=2, Terminated, Clinical history and knowledge of these features are necessary for excluding differential diagnoses and avoiding misdiagnosis. N=100 --> 2 | Trial completion date: Mar 2025 --> Jul 2020 | Recruiting --> Terminated | Trial primary completion date: Sep 2024 --> Jul 2020; Poor accrual
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Enrollment closed, Enrollment change: Alendronate Versus Denosumab in Kidney Transplant Patients (clinicaltrials.gov) - Dec 11, 2020 P2/3, N=90, Active, not recruiting, Active, not recruiting --> Completed | Trial primary completion date: Feb 2020 --> Dec 2020 Recruiting --> Active, not recruiting | N=60 --> 90
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Clinical, Journal: The safety profile of denosumab in oncology beyond the safety of denosumab as anti-osteoporotic agent: still more to learn. (Pubmed Central) - Dec 9, 2020 Despite the generally acceptable safety profile of denosumab in oncology, many issues remain unresolved. Further research is mandatory to counteract current challenges, namely: (i) validation of risk factors for adverse events; (ii) elucidation of the pathophysiology of the adverse events in search of actionable molecular pathways; (iii) illumination of the association of denosumab with increased risk of infections and/or second primary cancer; (iv) establishment of optimal diagnostic, and therapeutic protocols.
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Retrospective data, Review, Journal: Bone modifying agents for bone loss in patients with aromatase inhibitor as adjuvant treatment for breast cancer; insights from a network meta-analysis. (Pubmed Central) - Dec 2, 2020 Among the bisphosphonates, zoledronate increased BMD the most, but risedronate, not zoledronate, use was associated with lower risk of fracture. Denosumab increased BMD not only of LS but also of the cortical-bone-rich hip, and showed a significant reduction of fracture risk.
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Journal: Osteoporosis management in Australian general practice: an analysis of current osteoporosis treatment patterns and gaps in practice. (Pubmed Central) - Dec 1, 2020 In addition, it appears that most patients who ceased denosumab treatment had no record of subsequent antiresorptive therapy, which would place them at risk of further fractures. The study supports the need for the development of clinical education programs addressing GP knowledge gaps and attitudes, and the implementation of specific interventions such as good reminder/recall systems to avoid delays in reviewing and treating patients with osteoporosis.
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Journal: Preventive effect of fluvastatin on the development of medication-related osteonecrosis of the jaw. (Pubmed Central) - Dec 1, 2020 Medication-related osteonecrosis of the jaw (MRONJ) occurs in patients undergoing oral surgery while medicated with bisphosphonate, denosumab or anti-angiogenic agents...A MRONJ-like model was created by treating rats with zoledronate and dexamethasone, extracting teeth, and immediately injecting fluvastatin at the extraction site...Bone volume fraction calculated on μ-CT images was significantly larger in the FS-H group than in the MRONJ group (p = 0.021). Our findings suggest that a single local injection of fluvastatin following tooth extraction can potentially reduce the chance of developing MRONJ-like lesion in rats.
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Clinical, Journal: Osteoporosis medication use among Australian women over two decades. (Pubmed Central) - Dec 1, 2020 Use of anti-fracture medication among women at risk of fracture remained low over time. Investment into systems approaches to correct the treatment gap is warranted.
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Review, Journal: Therapeutic approach and management algorithms in medication-related osteonecrosis of the jaw (MONJ): recommendations of a multidisciplinary group of experts. (Pubmed Central) - Dec 1, 2020 The consensus group generated definitions and recommendations useful for doctors and dentists, following clinical algorithms involving four scenarios: osteoporosis patient who requires dental procedures and has not received antiresorptives, osteoporosis patient who are under treatment with antiresorptives, cancer patients, and MONJ-instituted patients. The therapeutic approach in osteoporosis and cancer patients, in invasive dental procedures, must be relied on the risk-benefit treatment.
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Trial completion date, Trial initiation date, Trial primary completion date: Study of XGEVA (clinicaltrials.gov) - Nov 30, 2020 P4, N=35, Not yet recruiting, The therapeutic approach in osteoporosis and cancer patients, in invasive dental procedures, must be relied on the risk-benefit treatment. Trial completion date: Jul 2025 --> Nov 2025 | Initiation date: Jun 2021 --> Oct 2021 | Trial primary completion date: Jul 2025 --> Nov 2025
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Enrollment closed, Trial completion date, Trial primary completion date: Denosumab for the Treatment of Adult LCH (clinicaltrials.gov) - Nov 30, 2020 P2, N=10, Active, not recruiting, Trial completion date: Jul 2025 --> Nov 2025 | Initiation date: Jun 2021 --> Oct 2021 | Trial primary completion date: Jul 2025 --> Nov 2025 Recruiting --> Active, not recruiting | Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: May 2021 --> May 2022
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Journal: New Frontiers in Osteoporosis Therapy. (Pubmed Central) - Nov 28, 2020 New approaches now in clinical use include the antisclerostin monoclonal antibody romosozumab, as well as the parathyroid hormone-related peptide analog abaloparatide...Expected final online publication date for the Annual Review of Medicine, Volume 71 is January 27, 2020. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.
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Clinical, Journal: Efficacy of denosumab co-administered with vitamin D and Ca by baseline vitamin D status. (Pubmed Central) - Nov 26, 2020 It was suggested that sequential therapy using ZOL could suppress the decrease of BMD, and increase of BTM, if the period of Dmab administration was less than 3 years. Among DIRECT trial subjects supplemented with ≥ 400 IU/day of vitamin D and ≥ 600 mg/day of Ca, baseline 25(OH)D sufficiency may not influence the efficacy of denosumab in increasing BMD or preventing vertebral fractures.
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