- |||||||||| Prolia (denosumab) / Amgen, Focus V (anlotinib) / Advenchen, Sino Biopharm
Journal: Clinical-proteomic classification and precision treatment strategy of chordoma. (Pubmed Central) - Oct 6, 2024 Notably, these approaches demonstrate positive treatment outcomes for each subtype in vitro and in vivo. Altogether, this work sheds light on the clinical-proteomic characteristics of chordoma and provides a candidate precision treatment strategy for chordoma according to molecular classification, underscoring their potential for clinical application.
- |||||||||| Prolia (denosumab) / Amgen
Journal: Giant cell tumor of the cervical spine: A very uncommon cause for cervical spine compression. (Pubmed Central) - Oct 4, 2024 She was proposed for adjuvant treatment based on Denosumab...Meanwhile, she experienced a pulmonary embolism leading to her demise. This case underscores the importance of considering giant cell tumors in the differential diagnosis of cervical spine lesions and emphasizes the successful and prompt management through a multidisciplinary approach involving surgical intervention and adjuvant therapy.
- |||||||||| Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Biomarker, Clinical, Retrospective data, Journal: Comparison of Denosumab with Romosozumab in the treatment of male osteoporosis: a retrospective cohort study. (Pubmed Central) - Oct 2, 2024 Conversely, with romosozumab, the levels of bone formation markers increased transiently at 6 months before returning to baseline, whereas bone resorption markers significantly decreased at both time points. Romosozumab demonstrated significantly superior effects over denosumab in improving BMD, especially of the lumbar spine, suggesting that romosozumab can be used for treating male osteoporosis.
- |||||||||| Prolia (denosumab) / Amgen
Review, Journal: Autologous platelet concentrates as adjuvant in the surgical management of medication-related osteonecrosis of the jaw. (Pubmed Central) - Sep 30, 2024 Medication-related osteonecrosis of the jaw (MRONJ) is an infectious side effect associated with bisphosphonates and monoclonal antibodies (denosumab, immune modulators, and antiangiogenic medications)...The overall results of this review have shown favorable healing rates of MRONJ lesions managed with the application of APCs after surgical treatment; however, significant methodological limitations may limit the scientific evidence supporting their use. Further randomized controlled trials with strict criteria are needed to establish the extent to which APCs can improve wound healing and quality of life in patients with MRONJ requiring surgical treatment.
- |||||||||| Prolia (denosumab) / Amgen
Retrospective data, Journal: Denosumab combined with en bloc resection and arthrodesis for recurrent grade 3 giant cell tumor of bone in distal radius. (Pubmed Central) - Sep 29, 2024 Further randomized controlled trials with strict criteria are needed to establish the extent to which APCs can improve wound healing and quality of life in patients with MRONJ requiring surgical treatment. Preoperative adjuvant denosumab therapy (PADT) combined with en bloc resection and arthrodesis is a promising method for the treatment of recurrent Campanacci III GCTB in distal radius with acceptable short-term local control and functional satisfaction.
- |||||||||| Pluvicto (lutetium Lu 177 vipivotide tetraxetan) / Novartis
Factors Influencing Clinical and Biological Response in Patients Treated with [177Lu]Lu-PSMA-617 under France's early access program. (e-Poster Area) - Sep 27, 2024 - Abstract #EANM2024EANM_2086; No significant differences (p>0.05) were observed between the responders and the non-responders with respect to patient age, ECOG score, initial PSA levels, metastasis locations, the number of previous NHT, the number of lines of taxane-based chemotherapy, and treatments received such as external radiotherapy, bisphosphonates, denosumab or immunotherapy. The response to [177Lu]Lu-PSMA-617 may be influenced by the number of [177Lu]Lu-PSMA-617 cycles administered, PSMA-PET lesion positivity and concurrent NHT administration.
- |||||||||| Prolia (denosumab) / Amgen
Review, Journal: Evaluating Treatment Modalities for Reducing Recurrence in Central Giant Cell Granuloma: A Narrative Review. (Pubmed Central) - Sep 27, 2024 Twenty-nine studies were reviewed, including six studies on surgical excision and curettage, eight studies on intralesional corticosteroid injections, six studies on calcitonin therapy, five studies on interferon-alpha therapy, and four studies on the therapy with denosumab...Aggressive surgical excision combined with nonsurgical methods may lower recurrence rates, while conservative techniques remain viable in some cases. Further prospective research is needed to validate these findings and enhance CGCG treatment options.
- |||||||||| Prolia (denosumab) / Amgen
Journal, Adverse events, Real-world evidence, Real-world: A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for denosumab. (Pubmed Central) - Sep 27, 2024 These findings underscore the critical importance of pharmacovigilance and are consistent with established clinical observations. Notably, osteonecrosis of the jaw, arthralgia, pain in extremities, back pain, myalgia, and bone pain were identified as the most prevalent risk signals associated with denosumab.
- |||||||||| Prolia (denosumab) / Amgen
Hypercalcemia in IgG4-Related Tubulointerstitial Nephritis: An Unusual Presentation (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_3214; Long-term management involves regular monitoring of renal function, disease activity, and avoiding potential complications such as renal failure or systemic involvement. Early recognition and intervention in TIN-IgG4, including thorough evaluations for hypercalcemia, are crucial for favorable outcomes and preventing disease progression.Laboratory values on admissionLaboratory TestsValuesUrine report/24 hrsValuesSerum urea72 mg/dLCalcium288 mgSerum creatinine3.04 mg/dLCreatinine770 mgPTH7 pg/mLProtein301 mgKappa free light chain56.70 mg/L--Lambda free light chain29.20 mg/L--1,25 dihydroxyvitamin D313.7 pg/mL--Total IgG15.90 g/L--IgG, immunoglobulin G; P-ANCA, perinuclear antineutrophil cytoplasmic antibodies; PHT, parathyroid hormone.
- |||||||||| Prolia (denosumab) / Amgen
Liquid Silicone Injections: An Infrequent Cause of CKD and Kidney Stones (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_2494; His AKI and hypercalcemia improved with intravenous fluid, denosumab, and calcitonin...If silicone cannot be removed, the treatment focuses on reduction of hypercalcemia and removal of kidney stones. Figure 1.CT scan abdomen and pelvis (A) showing kidney stones and axial view (B) showing extensive bilateral calcifications of the buttocks
- |||||||||| Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Depressive Symptoms and RANKL/OPG in Hemodialysis (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_2018; OPG wasn't significantly associated with depressive symptoms. Higher plasma RANKL levels were associated with lower depressive symptoms in HD patients.Odds ratios of plasma RANKL, OPG, and RANKL/OPG ratio for depressive symptoms OR (95% CI)UnadjustedP valueOR (95% CI)AdjustedP ValueRANKL tertile 1 Reference Reference RANKL tertile 20.51 (0.24-1.09)0.0800.42 (0.16-1.09)0.074RANKL tertile 30.40 (0.19-0.86)0.0180.31 (0.12-0.82)0.018OPG tertile 1Reference Reference OPG tertile 21.64 (0.78-3.44)0.1910.59 (0.20-1.69)0.326OPG tertile 31.37 (0.66-2.85)0.4010.29 (0.08-1.02)0.165RANKL/OPG tertile 1Reference Reference RANKL/OPG tertile 20.48 (0.23-1.03)0.0590.51 (0.20-1.32)0.041RANKL/OPG tertile 30.35 (0.17-0.75)0.0070.55 (0.21-1.42)0.256RANKL receptor activator of nuclear factor-?B ligand, OPG Osteoprotegerin, OR Odds Ratio, CI Confidential Interval Multivariate, adjusted for age, sex, BMI, Diabetes mellitus, cardiovascular diseases, HD vintage, spKt/V, hsCRP
- |||||||||| Prolia (denosumab) / Amgen
Calcium Chaos: When Siliconoma Steals the Show (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1232; The patient was treated with IV fluids, zoledronic acid, and calcitonin for 5 days and discharged on alendronate 70 mg weekly.Four months later, she was hospitalized with symptomatic hypercalcemia and was managed similarly...Over the next two years of receiving denosumab 120 mg monthly, hypercalcemia persisted, leading to recurrent nephrolitiasis and hydronephrosis, which further compromised kidney function...Siliconoma, though difficult to treat and often leading to complications like CKD, can result from an immune reaction to silicone, causing hypercalcemia by increasing calcium absorption through the production of 1,25 Vitamin D3.(1) Normalization of calcium could be related to the development of secondary hyperparathyroidism due to advanced CKD compared to treatment response as observed in this case. Due to the challenge in removing extensive granulomas, the development of alternative management strategies is crucial.
- |||||||||| Prolia (denosumab) / Amgen
Trial completion date, Trial primary completion date: Study of XGEVA (clinicaltrials.gov) - Sep 22, 2024 P4, N=35, Recruiting, The prevalence of frailty was high in the subgroup of elderly HD patients. Trial completion date: Oct 2027 --> May 2028 | Trial primary completion date: Oct 2027 --> May 2028
- |||||||||| Prolia (denosumab) / Amgen
Reimbursement, US reimbursement, Journal, Metastases: Spinal metastases and metastatic spinal cord compression: interpretation for National Institute for Health and Care Excellence (NICE) 2023 guideline (Pubmed Central) - Sep 21, 2024 In 2023, NICE launched new guidelines for spinal metastases and MSCC. Based on a thorough study of the guidelines, this article discusses and interprets pain management, corticosteroid treatment, application of bisphosphonates and denosumab, tools for assessing spinal stability and prognosis, radiation therapy, surgical timing and approach, etc., providing reference for clinical diagnosis and treatment in China.
- |||||||||| Prolia (denosumab) / Amgen
Review, Journal: The use of denosumab in osteoporosis - an update on efficacy and drug safety. (Pubmed Central) - Sep 20, 2024 Although bisphosphonates are often selected as initial therapy for osteoporosis, denosumab may be an appropriate initial therapy in patients at high risk for fracture, including older patients who have difficulty with the dosing requirements of oral bisphosphonates, as well as patients who are intolerant of, unresponsive to, or have contraindications to other therapies. Additional data is needed to address questions regarding treatment duration and discontinuation.
- |||||||||| HLX14 (denosumab biosimilar) / Fosun Pharma, Organon
Trial completion, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia (clinicaltrials.gov) - Sep 20, 2024 P3, N=514, Completed, Additional data is needed to address questions regarding treatment duration and discontinuation. Active, not recruiting --> Completed | Trial primary completion date: Apr 2024 --> Dec 2023
- |||||||||| Prolia (denosumab) / Amgen
Journal, Surgery: Post-craniopharyngioma surgery hypocalcemia due to denosumab use for osteoporosis: A case report. (Pubmed Central) - Sep 20, 2024 More large RCTs are needed to verify these results. It underscores the necessity for clinicians to perform a thorough evaluation of the patient's overall health status, complete all requisite testing, pay particular attention to those in high-risk categories, and ensure serum calcium levels are monitored, along with conducting other essential tests, prior to and following each administration of denosumab.
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, Prolia (denosumab) / Amgen, Pluvicto (lutetium Lu 177 vipivotide tetraxetan) / Novartis
Clinical, Journal, Metastases: Lu-177 PSMA vs Comparator Treatments and Survival in Metastatic Castration-Resistant Prostate Cancer. (Pubmed Central) - Sep 20, 2024 Observed treatment effects on overall survival (OS) differed substantially in the first 2 randomized clinical trials of lutetium Lu 177 vipivotide tetraxetan (Lu-177) prostate-specific membrane antigen (PSMA) in metastatic castration-resistant prostate cancer...VISION randomized participants to receive treatment with or without Lu-177 PSMA in addition to physicians' choice of protocol-permitted treatments (PPT; approved hormonal treatments [such as abiraterone and enzalutamide], bisphosphonates, radiotherapy, denosumab, or glucocorticoids), excluding cabazitaxel...Findings of this secondary analysis of the TheraP and VISION randomized clinical trials suggest that the choice of comparator treatments (ie, cabazitaxel vs PPT) may explain the difference in the observed effect of Lu-177 PSMA on OS between the 2 trials. Causal inference methods such as RPSFTM and IPCW may help rule out crossover as a plausible explanation.
- |||||||||| Prolia (denosumab) / Amgen
Clinical, Retrospective data, Review, Journal: Impact of anti-fracture medications on bone material and strength properties: a systematic review and meta-analysis. (Pubmed Central) - Sep 11, 2024 Additionally, anti-resorptives (bisphosphonates and denosumab) significantly increased crystallinity [SDM 0.387], mineral-matrix ratio [SDM 0.771], microhardness [SDM 0.858], and contact hardness [SDM 0.952] of cortical bone...In strontium ranelate-treated patients, there was no difference in BMPs compared to placebo. Collectively, our study suggests that AFMs improve bone quality, which explains their anti-fracture ability that is not fully accounted for by increased BMD in osteoporosis patients.
- |||||||||| Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB, Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
ASSOCIATION OF MONOCLONAL ANTIBODY TREATMENT WITH THE DEVELOPMENT OF STRESS CARDIOMYOPATHY (Convention Center Exhibit Hall: Poster Area 1) - Sep 11, 2024 - Abstract #CHEST2024CHEST_6320; The FRAME study found similar incidence of cardiovascular events with romosozumab-denosumab compared to placebo-denosumab [1]...An analysis of the reSURFACE 1 and 2 trials found limited cardiovascular events with tildrakizumab, similar to placebo [3]... This case highlights a potential association between monoclonal antibodies and stress cardiomyopathy, however, the exact mechanism is uncertain emphasizing the need for further research.
- |||||||||| Prolia (denosumab) / Amgen
Review, Journal, Checkpoint inhibition: Response rate specific to bone metastasis of various cancers for immune checkpoint inhibitors: a systematic review. (Pubmed Central) - Sep 5, 2024 We confirm that the CIM threshold values determined in the OsteoGeo study are generally valid for this much larger and diverse surveillance study group covering a diverse population encompassing various medical conditions and therapies. Although response rates to ICIs for BM are poor, patients treated with ICI plus denosumab for bone metastases with impending fractures from NSCLC and melanoma are likely to avoid surgery to prevent fractures.
- |||||||||| Prolia (denosumab) / Amgen
Journal: Three cases of uncommon medication-associated osteonecrosis of temporal bone. (Pubmed Central) - Sep 5, 2024 She had a history of osteoporosis treated with denosumab and risedronic acid...He had a history of osteoporosis treated with alendronic acid and zoledronic acid...He had a history of chronic myelogenous leukemia treated with a tyrosine-kinase inhibitor, imatinib...Anti-resorptive agents and/or tyrosine kinase inhibitors may lead to dysregulation of bone remodeling and result in rare cases of temporal bone osteonecrosis. When a local debridement and antibiotic therapy fail, definitive surgical excision of necrotic bone with subsequent reconstruction of the EAC may offer patients a possible resolution in symptoms.
- |||||||||| Prolia (denosumab) / Amgen
Enrollment closed: TRIDENT: RANKL Inhibition and Mammographic Breast Density (clinicaltrials.gov) - Sep 4, 2024 P2, N=210, Active, not recruiting, When a local debridement and antibiotic therapy fail, definitive surgical excision of necrotic bone with subsequent reconstruction of the EAC may offer patients a possible resolution in symptoms. Recruiting --> Active, not recruiting
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