- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, Real-world evidence, Patient reported outcomes: Real-world patient-reported outcomes of breast cancer or prostate cancer patients receiving antiresorptive therapy for bone metastases: Final results of the PROBone registry study. (Pubmed Central) - Mar 29, 2022
Antiresorptive treatment, such as denosumab and bisphosphonates, can help to reduce the frequency of skeletal complications, to control bone pain and potentially to improve QoL...This point gains even more importance as our data support current recommendations by ESMO guidelines as well as by German evidence-based S3-guidelines for diagnosis and treatment of breast and prostate cancer to initiate bone-targeted agents (BTA) as soon as BM are diagnosed, to keep pain levels at the lowest level possible, to minimize the debilitating effects of metastatic bone pain and maintain a good QoL. Bone pain management by an early use of BTA following BM diagnosis might improve patient care.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Metabolic Bone Diseases and New Drug Developments. (Pubmed Central) - Mar 29, 2022
A large amount of research literature suggests that balanced nutrition and balanced periodic supplementation of calcium, phosphate, and vitamin D can improve re-absorption and the regrowth of bones, and inhibit the formation of skeletal fractures, except in the case of hereditary bone diseases. Meanwhile, new and improved drug formulations, such as raloxifene, teriparatide, sclerostin, denosumab, and abaloparatide, have been successfully developed and administered as treatments for metabolic bone diseases, while others (romososumab and odanacatib) are in various stages of clinical trials.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: LENVOS: Study of the Efficacy of Lenvatinib Combined With Denosumab in the Treatment of Patients With Predominant Bone Metastatic Radioiodine Refractory Differentiated Thyroid Carcinomas (clinicaltrials.gov) - Mar 29, 2022
P2, N=35, Recruiting,
Meanwhile, new and improved drug formulations, such as raloxifene, teriparatide, sclerostin, denosumab, and abaloparatide, have been successfully developed and administered as treatments for metabolic bone diseases, while others (romososumab and odanacatib) are in various stages of clinical trials. Trial completion date: Jun 2022 --> Jan 2023 | Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Bone disease ([VIRTUAL]) - Mar 26, 2022 - Abstract #EMN2022EMN_92;
Radiotherapy should be considered for uncontrolled pain due to impeding or symptomatic spinal cord compression and due to pathological fractures. Surgery should be considered for prevention and restoration of long-bone pathological fractures, vertebral column instability and spinal cord compression with bone fragments within the spinal route.
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Journal: COVID pandemic and denosumab adherence. (Pubmed Central) - Mar 25, 2022
Clinical trials to evaluate the long-term effects and safety of denosumab in children are ongoing. No abstract available
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Mechanisms of acute hypercalcemia in pediatric patients following the interruption of Denosumab. (Pubmed Central) - Mar 23, 2022
Our data suggest that precautions must be taken when Denosumab therapy is interrupted and gradual decrease of dose and/or timing of treatment should be performed. To prevent the onset of hypercalcemia that could be in the discontinuation phase, cytofluorimetric analysis of PBMC should be performed to evaluate osteoclast precursors.
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Clinical, Journal, HEOR, Real-world evidence: A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China. (Pubmed Central) - Mar 23, 2022
On June 23, 2020, Prolia (denosumab) was approved by the National Medical Products Administration (NMPA) in the People's Republic of China as the first monoclonal antibody for the treatment of postmenopausal women with osteoporosis at high risk of fractures...The benefits of such an approach include avoiding the collection of additional placebo-controlled trial data in populations where adequate ethnic characterization of efficacy, effectiveness, and safety may already exist from postmarketing sources, and accelerate access for patients to innovative medicines in important regions. Here, we describe a regulatory case study of a novel MAA incorporating RWE that provided important evidence to confirm the benefit:risk of a new drug and facilitated a label expansion to a new patient population.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Endocrinology of bone mineralization: an update. (Pubmed Central) - Mar 23, 2022
Diagnosis is based on clinical history, phosphocalcic metabolism assessment and, if necessary, molecular characterization, and must be rapid in order to initiate the most appropriate treatment and consider new treatments such as burosumab if necessary...The question of treatment sequencing in osteoporosis is another challenge, notably after denosumab cessation, complicated by a decrease in bone mineral density and increased risk of fracture...New treatments are also available, including romosozumab, a humanized monoclonal antibody which promotes bone formation and inhibits bone resorption by inhibiting sclerostin. Romosozumab is approved in several countries, including France, for treating severe osteoporosis in postmenopausal women at high risk of fracture and free of cardiovascular comorbidity.Endocrinologists need to be aware of these fragilizing osteopathies in order to improve both diagnosis and treatment.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Denosumab for the Treatment of Hypercalcemia in a Patient With Parathyroid Carcinoma: A Case Report. (Pubmed Central) - Mar 19, 2022
Repeated administration of zoledronic acid only had transient effects on calcium levels, and bisphosphonate treatment was ultimately discontinued because of chronic renal failure...Several case reports studied denosumab in hypercalcemia due to parathyroid carcinoma, and the treatment were efficient to decrease levels of calcium when repeated as needed or monthly. We report another case of refractory hypercalcemia treated with several doses of denosumab in a patient with parathyroid carcinoma.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: A Review of Current Clinical Concepts in the Pathophysiology, Etiology, Diagnosis, and Management of Hypercalcemia. (Pubmed Central) - Mar 19, 2022
Initial treatment involves vigorous intravenous hydration and drugs to reduce bone resorption such as bisphosphonates and, more recently, denosumab, in refractory cases; also, corticosteroids and calcitonin can be used in specific cases. This review aims to provide a clinical update on current concepts of the pathophysiology of calcium homeostasis, epidemiology, screening, clinical presentation, diagnosis, and management of hypercalcemia.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Review, Journal: Review and Update of the Risk Factors and Prevention of Antiresorptive-Related Osteonecrosis of the Jaw. (Pubmed Central) - Mar 16, 2022
Antiresorptive-related osteonecrosis of the jaw (ARONJ) is a rare but serious adverse event of bisphosphonate or denosumab administration; it is associated with severe pain and a deteriorated quality of life...Furthermore, close cooperation between prescribing physicians and dentists is important. The aim of this review was to provide up-to-date information regarding the risk factors and prevention of ARONJ from a physician's perspective.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Skeletal abnormalities in Hypoparathyroidism and in Primary Hyperparathyroidism. (Pubmed Central) - Mar 15, 2022
This article reviews skeletal involvement in HypoPT and in PHPT, as assessed by bone remodeling, DXA, trabecular bone score, and quantitative computed tomography, as well as data on bone strength and fracture risk. The effects of PTH replacement on the skeleton in subjects with HypoPT, and the outcome of parathyroidectomy in patients with PHPT, are also reviewed here.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Update on Glucocorticoid Induced Osteoporosis. (Pubmed Central) - Mar 15, 2022
Teriparatide has been shown to have a preventive effect on vertebral fractures, but not on nonvertebral fractures. In this article we aimed to provide an update on glucocorticoid-induced osteoporosis by focusing on the assessment of its risk and treatment options.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Long-Term Treatment of Postmenopausal Osteoporosis. (Pubmed Central) - Mar 15, 2022
This publication addresses how best to use the pharmacological options available for postmenopausal osteoporosis to provide lifelong fracture protection in patients at high and very high risk of fracture. The benefit of osteoporosis therapies far outweighs the rare risks.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Preclinical, Journal: Osteoinductive potential of recombinant BMP-9 in bone defects of mice treated with antiresorptive agents. (Pubmed Central) - Mar 15, 2022
In line with in vivo study, bone marrow cells isolated from both sham and mAb-treated mice confirmed greater osteogenic potential upon stimulation with rhBMP-9 in vitro. These findings suggest for the first time that local rhBMP-9 administration might be a strategy to accelerate bone regeneration in the context of AMART.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Modeling-Based Bone Formation After 2 Months of Romosozumab Treatment: Results From the FRAME Clinical Trial. (Pubmed Central) - Mar 15, 2022
P3
Participants in the bone biopsy substudy received quadruple tetracycline labeling and underwent transiliac biopsies at month 2...After 2 months, the median percentage of MBBF referent to the total bone surface was significantly increased with romosozumab vs placebo on cancellous (18.0% vs 3.8%; p =?0.005) and endocortical (36.7% vs 3.0%; p =?0.001), but not on periosteal (5.0% vs 2.0%; p =?0.37) surfaces, with no significant difference in the surface extent of RBBF on all three bone surfaces. These data show that stimulation of bone formation in the first 2 months of romosozumab treatment in postmenopausal women with osteoporosis is predominately due to increased MBBF on endocortical and cancellous surfaces.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Analysis of Denosumab by a Validated CZE Method and Determination of Sialic Acids by the RP-HPLC Method. (Pubmed Central) - Mar 15, 2022
An RP-HPLC method with fluorescence detection (RP-HPLC-F), performed on a Kinetex® EVO C18 column (5 μm, 100 Å, 250 mm × 4.6 mm), was optimized to determine the levels of sialic acids of DmAb biomolecules, giving mean concentrations of 0.16 and 0.17 μg N-acetylneuraminic acid/mg DmAb for Prolia® and Xgeva® pharmaceutical products, respectively. The results demonstrated the capability of each one of the methods, and their use in combination constitutes a strategy to monitor instability, thereby assuring the quality and the batch-to-batch consistency of the biotechnology-derived medicine.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Romosozumab Reduces Incidence of New Vertebral Fractures Across Severity Grades Among Postmenopausal Women with Osteoporosis. (Pubmed Central) - Mar 12, 2022
P3
Reductions in the incidence of new moderate and severe VFs were sustained through 24 months, after transition from romosozumab to denosumab or alendronate, independent of baseline VF prevalence or severity; no significant interactions were observed between the incidence of new moderate-or-severe VFs and the presence of prevalent (FRAME; p=0.81) or severe (ARCH; p=0.99) VFs at baseline. With increasing recommendations for initial treatment with bone-forming agents for postmenopausal women with osteoporosis, these analyses will help to inform treatment decisions for patients at very high risk of VF.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Systemic effects of abnormal bone resorption on muscle, metabolism, and cognition. (Pubmed Central) - Mar 12, 2022
Currently available bone-targeting therapies such as bisphosphonates and denosumab inhibit bone resorption, decrease morbidity associated with bone destruction, and improve survival...To be able to identify the molecular link between bone and distant organs during abnormal bone resorption and then treat these abnormalities and prevent their systemic effects could improve survival benefits. The current review highlights the link between bone resorption and its systemic effects on muscle, pancreas, and brain.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Nonoperative and Operative Bone and Cartilage Regeneration and Orthopaedic Biologics of the Hip: An Orthoregeneration Network (ON) Foundation Hip Review. (Pubmed Central) - Mar 11, 2022
Promising and established treatment modalities for osteonecrosis include nonweightbearing; pharmacological treatments including low molecular-weight heparin, prostacyclin, statins, bisphosphonates, and denosumab, a receptor activator of nuclear factor-kB ligand inhibitor; extracorporeal shock wave therapy; pulsed electromagnetic fields; core decompression surgery; cellular therapies including bone marrow aspirate comprising mesenchymal stromal cells (MSCs aka mesenchymal stem cells) and bone marrow autologous concentrate, with or without expanded or cultured cells, and possible addition of bone morphogenetic protein-2, vascular endothelial growth factor, and basic fibroblast growth factor; and arterial perfusion of MSCs that may be combined with addition of carriers or scaffolds including autologous MSCs cultured with beta-tricalcium phosphate ceramics associated with a free vascularized fibula...LEVEL OF EVIDENCE: Level V, expert opinion. Hip Orthoregeneration for Osteonecrosis and Chondral Defects.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Denosumab in the Treatment of Osteoporosis: 10 Years Later: A Narrative Review. (Pubmed Central) - Mar 9, 2022
Taken together, the available data show that denosumab has a favorable benefit/risk profile and is a versatile agent for preventing osteoporotic fractures in the short and long term. Video abstract: Denosumab in the Treatment of Osteoporosis-10 Years Later (MP4 62727 KB).
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Remote management of osteoporosis in the first wave of the COVID-19 pandemic. (Pubmed Central) - Mar 9, 2022
This large group of osteoporotic patients showed high compliance and lower COVID-19 lethality compared to patients of the same age. Novel approaches such as telemedicine can provide critical support for the remote follow-up of patients with chronic diseases also in the setting of routine care.
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