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[VIRTUAL] Bones Versus Teeth () - Mar 27, 2021 - Abstract #ENDO2021ENDO_3199;
At age 84 she began ibandronate but stopped due to worsening of esophageal reflux...Her dentist recommended the extraction of several teeth before beginning zoledronate...Bone health treatments such as bisphosphonates and denosumab are generally safe but can potentially cause osteonecrosis of the jaw even with simple tooth extraction in old-old population...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021.
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[VIRTUAL] Treatment of Polyostotic Fibrous Dysplasia With Intravenous Ibandronate () - Mar 27, 2021 - Abstract #ENDO2021ENDO_3196;
Zoledronic acid is commonly used however our patient developed APR to the first dose and refused retrial...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021.
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[VIRTUAL] Fracture Rates in Men With Non-Metastatic Prostate Cancer on Androgen Deprivation Therapy With or Without Anti-Osteoporosis Treatment () - Mar 27, 2021 - Abstract #ENDO2021ENDO_3177;
Anti-OsteoRx included bisphosphonates, denosumab, and parathyroid hormone analogs. Fracture rate subgroups: • ADT only - Anti-OsteoRx 37/ 374 fractured (9.89%) • ADT only + Anti-OsteoRx 10/52 fractured (19.23%) • ADT + SupplRx + Anti-OsteoRx 2/19 fractured (10.53%) • ADT + SupplRx + Anti-OsteoRx 13/170 fractured (7.65%) Comparing fracture rates between subgroups: • Comparing ADT only +/- Anti-OsteoRx, statistical significance was observed with higher fracture rate in patients taking Anti-OsteoRx (19.23% vs. 9.89%, p < 0.044) • Comparing ADT + SupplRx +/- Anti-OsteoRx, no significant difference in fracture rates due to small number of fractures Comparing combined subgroups: • ADT +/- SupplRx + Anti-OsteoRx 12/71 (16.9%) fractured • ADT +/- SupplRx - Anti-OsteoRx 50/544 (9.19%) fractured • Statistically significant between groups fracture rates was observed (p= 0.042) in patients treated with Anti-OsteoRX Patients receiving Anti-OsteoRx, regardless of their prostate cancer therapies, had higher rates of fractures (16.9 vs. 9.19%, p= 0.042) due to their being selected for therapy based on greater clinical risks.
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[VIRTUAL] Meet the Professor () - Mar 27, 2021 - Abstract #ENDO2021ENDO_2934;
Zoledronate: Zoledronate is usually given at intervals of 1-2 years...Anabolics (teriparatide, abaloparatide, romosozumab): BMD gains during treatment are lost in the months following cessation...In patients having had treatment for >5 years, prevention of rebound bone loss appears to be more difficult, so more intensive bisphosphonate therapy may be required with close monitoring of bone resorption markers and BMD. Patients starting denosumab should be told of this phenomenon so they know that they must not delay injections or discontinue them without transition to a bisphosphonate.
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Journal: Local administration and enhanced release of bone metabolic antibodies from hydroxyapatite/chondroitin sulfate nanocomposite microparticles using zinc cations. (Pubmed Central) - Mar 26, 2021
Herein, we report the release properties of model antibodies such as immunoglobulin (IgG), human IgG (hIgG), and denosumab (Dmab) from HAp/ChS using this formulation method...After three weeks, the area of the newly formed osteoid around the drilled hole where HAp/ChS loaded with Sclmab and Zn was locally administered was significantly higher than that observed in the control group (normal saline). Thus, HAp/ChS microparticles and the formulation method of monoclonal antibodies using Zn could be useful in the treatment of local bone diseases.
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Journal: Osteoporosis treatment (Pubmed Central) - Mar 26, 2021
The patient must be informed of the benefits, risks, and duration of treatment and the consolidation treatment required after teriparatide or denosumab discontinuation. Adherence and tolerance to treatment must be monitored to ensure its efficiency.
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Journal: Repurposing denosumab in lung cancer beyond counteracting the skeletal related events: an intriguing perspective. (Pubmed Central) - Mar 24, 2021
Given the improvement of lung cancer prognosis ascribed to revolutionary targeted treatment agents, the possibility of denosumab-related increased risk of second primary malignancies merits further evaluation. Many challenges in endorsing denosumab as a strategy to treat lung cancer beyond SREs prevention are pending counteraction, including: (i) patient selection guided by validated predictive and prognostic biomarkers; (ii) assessment of long-term outcomes; (iii) evaluation of benefit-risk ratio; (iv) translational research; (v) combination of denosumab with other targeted therapies; (vi) integration of genomic biomarkers, immune-related biomarkers, and biomarkers of active RANKL pathway to guide the decision-making process.
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Journal: Denosumab for Cancer-Related Bone Loss. (Pubmed Central) - Mar 24, 2021
Adjuvant six-monthly denosumab delays the time to first fracture onset in early stage breast cancer patients with normal or altered bone mineral density (BMD). Similarly, denosumab treatment is able to prevent fractures and BMD loss in non-metastatic prostate cancer patients.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Mailishu (denosumab biosimilar) / Mabwell (Shanghai) Biosci, Binnopharm
New P3 trial: Efficacy and Safety of MW032 and Xgeva (clinicaltrials.gov) - Mar 22, 2021
P3, N=706, Active, not recruiting,
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Review, Journal: Review of Bone Modifying Agents in Metastatic Breast Cancer. (Pubmed Central) - Mar 20, 2021
Current American Society of Clinical Oncology (ASCO) guidelines recommend denosumab 120 mg subcutaneously every four weeks, or zolendronic acid 4 mg every four weeks or every 12 weeks, or intravenous pamidronate 90 mg every four weeks...Current ASCO guidelines recommend continuing BMAs indefinitely, however, in clinical practice, this decision needs to be individualized, especially since there is no data on the impact of long-term use of BMAs. Further studies would need to be developed to develop an algorithm of SRE risk assessment and to determine which patients would benefit from BMAs.
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[VIRTUAL] PILOT STUDY OF BONE RESISTANCE MEASURED IN VIVO BY IMPACT MICROINDENTATION IN KIDNEY TRANSPLANTATION (Mini-Orals Hall) - Mar 19, 2021 - Abstract #ERAEDTA2021ERA_EDTA_974;
IMI is a technique with excellent tolerance that may offer complementary information on bone quality in the global assessment of bone resistance. IMI may allow the detection of EARLY changes in bone resistance in corticosteroid-treated KT patients with/without antiresorptives added to prophylactic treatment with calcium and vitamin D.
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[VIRTUAL] DENOSUMAB: NOVEL APPROACH TO TREATMENT OF OSTEOPOROSIS IN RENAL DISEASE (Mini-Orals Hall) - Mar 19, 2021 - Abstract #ERAEDTA2021ERA_EDTA_741;
Denosumab may have advantages in patients with kidney dysfunction, because not excreted by the kidney and there is no need for dose adjustment. This prospective study showed a significant improvement in osteoporosis (at Dexa mean T- score ≤ -1), but particular attention should be paid to ensuring that patients are calcium and Vitamin D replete.
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Clinical, Journal: Treatments of osteoporosis increase bone material strength index in patients with low bone mass. (Pubmed Central) - Mar 19, 2021
PTH and abaloparatide are less tolerated than placebo whereas the eight other drugs assessed in the study have the same tolerability as placebo. In patients at increased fracture risk, antiresorptive treatments induced BMD-independent increases in BMSi values, the magnitude of which depended on pretreatment values.
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Clinical, Review, Journal: Methotrexate osteopathy: five cases and systematic literature review. (Pubmed Central) - Mar 19, 2021
Our cohort of 5 cases represent the largest series of the literature. Pathophysiological studies raised the question of a dose-dependent remnant effect of MTX on osteo-forming bone cells.
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Retrospective data, Review, Journal: Denosumab is not associated with risk of malignancy: systematic review and meta-analysis of randomized controlled trials. (Pubmed Central) - Mar 19, 2021
Early concerns about a potential increased risk of malignancy resulting from an immunomodulatory effect of denosumab are not supported by evidence from this meta-analysis of 25 RCTs with drug exposure of up to 48 months. Since RCTs with longer observation for safety outcomes are not expected, post-marketing surveillance will be the main means for detection of rare or late-occurring events.
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Journal: Zoledronic Acid after Treatment with Denosumab is Associated with Bone Loss within 1 Year. (Pubmed Central) - Mar 19, 2021
This study suggests that buffered soluble ALN represents a cost-effective strategy compared with relevant alternative treatments for postmenopausal osteoporosis women in Italy aged 60 years and over. A single dose of ZA administered approximately 6 months after denosumab leads to some BMD loss, mostly within 1 year of ZA administration, particularly in patients with osteoporosis at the time of denosumab discontinuation.
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Journal: Denosumab Recovers Aortic Arch Calcification During Long-Term Hemodialysis. (Pubmed Central) - Mar 19, 2021
Denosumab effects on decalcification were not observed 12 months after initiation. We conclude that long-term use of denosumab is effective to reverse or treat AoAC in patients undergoing hemodialysis.
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Review, Journal: Treatment of multiple myeloma-related bone disease: recommendations from the Bone Working Group of the International Myeloma Working Group. (Pubmed Central) - Mar 16, 2021
After assessing the available literature and grading recommendations using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) method, experts from the working group recommend zoledronic acid as the preferred bone-targeted agent for patients with newly diagnosed multiple myeloma, with or without multiple myeloma-related bone disease...Denosumab can also be considered for the treatment of multiple myeloma-related bone disease, particularly in patients with renal impairment...Radiotherapy is recommended for uncontrolled pain, impeding or symptomatic spinal cord compression, or pathological fractures. Surgery should be used for the 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: Anorexia Nervosa with Markedly High Bone Turnover and Hyperphosphatemia During Refeeding Rectified by Denosumab. (Pubmed Central) - Mar 12, 2021
Denosumab 60 mg was administered that was followed by: rapid normalisation of serum phosphate; normalisation of resorption markers, transient hypocalcaemia with secondary hyperparathyroidism, and normalisation of both TmPO4/GFR and C-terminal FGF23. We speculate that prolonged immobilization as part of AN management led to a high remodelling state followed by hyperphosphatemia and high-normal calcium with appropriate suppression of PTH and that marked hyperphosphatemia and high TmP/GFR despite high FGF23 indicates the necessity of PTH adequacy for excess FGF23 to lower TmP/GFR.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Clinical, Journal, Real-World Evidence: Characterizing patients initiating abaloparatide, teriparatide, or denosumab in a real-world setting: a US linked claims and EMR database analysis. (Pubmed Central) - Mar 12, 2021
Minodronate or denosumab can be used for preventing bone loss related to ADT in Asian patients with PCa. Patients initiating ABL and TPTD differed in sex, age, pathologic fractures, comorbidity index, and prior bisphosphonate use compared with those initiating DMAB.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Clinical, Review, Journal: Hypercalcemia upon denosumab withdrawal in primary hyperparathyroidism: a case report and literature review. (Pubmed Central) - Mar 12, 2021
A surgical approach by minimally invasive parathyroidectomy allowed for definite resolution of hyperparathyroidism and hypercalcemia. This case suggests that hypercalcemia can be a side consequence of denosumab discontinuation, which can become severe when other causes of hypercalcemia, such as primary hyperparathyroidism, are present.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial completion date, Trial primary completion date: Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration (clinicaltrials.gov) - Mar 11, 2021
P4, N=36, Recruiting,
In summary, these reporter-based bioassays provide valuable tools for the development, stability testing, and potency determination in the manufacture of cytokine biosimilars and biobetters. Trial completion date: Nov 2021 --> Jun 2022 | Trial primary completion date: Nov 2021 --> Mar 2022
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, Repatha (evolocumab) / Amgen, Astellas
Evolocumab + niacin+ Prolia (Twitter) - Mar 10, 2021
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