- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Osteoporosis in children and adolescents: how to treat and monitor? (Pubmed Central) - Dec 7, 2022 This clinical review focuses on the prevention, treatment, and follow-up of children with, or at risk of developing, osteoporosis and the transition from pediatric to adult care.
- |||||||||| zamaporvint (RXC004) / Redx
Enrollment change, Trial completion date, Trial primary completion date, Metastases: KEYNOTE-E86: A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2) (clinicaltrials.gov) - Dec 7, 2022 P2, N=80, Recruiting, This clinical review focuses on the prevention, treatment, and follow-up of children with, or at risk of developing, osteoporosis and the transition from pediatric to adult care. N=40 --> 80 | Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Mar 2023 --> Jun 2023
- |||||||||| Xofigo (radium Ra-223 dichloride) / Bayer
Review, Journal: Current and future targeted alpha particle therapies for osteosarcoma: Radium-223, actinium-225, and thorium-227. (Pubmed Central) - Dec 3, 2022 P1, P1/2 A case of an inoperable left upper lobe vertebral-paraspinal-mediastinal osteoblastic lesion treated successfully with Ra combined with gemcitabine is described. Because not all areas of osteosarcoma lesions are osteoblastic, but nearly all osteosarcoma cells overexpress IGF1R, and some subsets expressing Her-2, the anti-IGF1R antibody FPI-1434 linked to actinium-225 (Ac) or the Her-2 antibody linked to thorium-227 (Th) may become other means to provide targeted alpha particle therapy against osteosarcoma (NCT03746431 and NCT04147819).
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Review, Journal: A systematic review and meta-analysis of interventional studies of bisphosphonates and denosumab in multiple myeloma and future perspectives. (Pubmed Central) - Dec 3, 2022 Results are mixed regarding the efficacy of pamidronate in reducing skeletal related events...DENOS demonstrated non-inferiority to ZOL, in improving overall survival [pooled Hazard Ratio(HR) 1.02(95% CI 0.72,1.44)], progression free survival [pooled HR 0.92(95% CI 0.76,1.11)] and in reducing skeletal related events [pooled HR 1.03(95% CI 0.92,1.16)], with similar rates of ONJ and better safety profile regarding renal toxicity. Denosumab has comparable efficacy and safety with ZOL and may even replace BPs in the future, in the management of myeloma bone disease.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
New P4 trial: Efficacy and Safety of Actonel (clinicaltrials.gov) - Nov 30, 2022 P4, N=155, Not yet recruiting,
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Blue lacy matrix in giant cell tumour of bone with or without denosumab therapy. (Pubmed Central) - Nov 30, 2022 The matrix was associated with depletion of osteoclast-like giant cells and fascicular proliferation of spindle cells, regardless of the history of denosumab therapy. Recognising this unique matrix will help avoid confusion with other bone tumours with different clinical management.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Denosumab for the Treatment of Smoldering Multiple Myeloma: Rates of Osteoporosis and Change in Lowest T-Score after 12 Months of Treatment () - Nov 29, 2022 - Abstract #ASH2022ASH_7746; All progression of disease has been biochemical and there have been no skeletal-related events recorded at the time of this report.Conclusion : While there appears to be minimal disease response of SMM to denosumab, there does appear to be either stable or increased bone mineral density in the majority of patients that have completed therapy thus far. All patients that have progressed since initiation of the study experienced biochemical progression and no patients have had skeletal-related events at the time of this report.
- |||||||||| Jardiance (empagliflozin) / Eli Lilly, Boehringer Ingelheim
Repurposing of Empagliflozin as Treatment for Neutropenia in Glycogen Storage Disease Type Ib: A Case Report (Poster Gallery) - Nov 29, 2022 - Abstract #IDF2022IDF_976; The CDAI decreased to 52 and stool calprotectin levels decreased from 141 to 35 μg/g (>50 representing a marker of intestinal inflammation). Her serum 1,5AG level decreased from 140.07 to 33.87 μM after 10 months of treatmentConclusionEmpagliflozin is a new alternative for neutropenia and can also ameliorate IBD symptoms in GSD-1b patients
- |||||||||| RGB-14-P (denosumab biosimilar) / Gedeon Richter
Enrollment closed, Trial primary completion date: Comparative Efficacy and Safety Study of RGB-14-P and Prolia (clinicaltrials.gov) - Nov 29, 2022 P3, N=473, Active, not recruiting, Her serum 1,5AG level decreased from 140.07 to 33.87 μM after 10 months of treatmentConclusionEmpagliflozin is a new alternative for neutropenia and can also ameliorate IBD symptoms in GSD-1b patients Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2023 --> Nov 2023
- |||||||||| SB16 (denosumab biosimilar) / Samsung
Trial completion, Trial completion date, Trial primary completion date: Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects (clinicaltrials.gov) - Nov 28, 2022 P1, N=168, Completed, Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2023 --> Nov 2023 Recruiting --> Completed | Trial completion date: Aug 2021 --> Nov 2022 | Trial primary completion date: Aug 2021 --> Nov 2022
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Pathophysiology and therapeutic advances in myeloma bone disease. (Pubmed Central) - Nov 25, 2022 Denosumab is preferred in patients with MM and renal dysfunction. Although effective drugs have been approved, antimyeloma therapy is the most important method for controlling bone disease.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Orkedia (evocalcet) / Mitsubishi Tanabe, Kyowa Kirin
Journal, Combination therapy: A Case of Successful Control of Hypercalcemia with Sorafenib, Evocalcet, and Denosumab Combination Therapy for Recurrent Parathyroid Carcinoma. (Pubmed Central) - Nov 22, 2022 In this case, the serum calcium level was under control for 10 months after the initiation of sorafenib. This case suggests that combination therapy with sorafenib, evocalcet, and denosumab may be an alternative, stronger management option for refractory hypercalcemia in recurrent PC.
- |||||||||| cinacalcet HCl / Generic mfg.
Journal: Refractory paraneoplastic hypercalcaemia responding to cinacalcet. (Pubmed Central) - Nov 22, 2022 Her hypercalcaemia initially responded to intravenous fluids, and later on zolendronate,but the problem recurred again, with the response to a repeat dose of zolendronate and even denosumab being unsatisfactory. As a last resort cinacalcet was started, and although there was a good response to it, our patient sadly died a few weeks later.We believe our case to be the first case of hypercalcaemia associated with isolated bladder cancer which showed a successful response to cinacalcet.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Asclera (polidocanol) / Merz Pharma
Journal: The treatment of aneurysmal bone cysts. (Pubmed Central) - Nov 22, 2022 Systematic therapy with denosumab exhibits favorable results but should be reserved in the pediatric population for unresectable lesions, as it may result in severe hypercalcemia in children. When selecting a treatment option, localization, stability and safety should be considered.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Discontinuation of denosumab in men with prostate cancer. (Pubmed Central) - Nov 21, 2022 In men with non-metastatic prostate cancer, discontinuation of DMAB after stopping ADT led to an average bone loss of 2-5%. Zoledronate prevented bone loss in men with osteopenia.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Treating osteoporosis: risks and management. (Pubmed Central) - Nov 18, 2022 Romosozumab is a new anabolic treatment for osteoporosis and, together with teriparatide, is subsidised as second-line therapy for individuals with severe disease and multiple fractures. Specialist referral should be considered for patients who sustain fractures while undergoing osteoporosis therapy.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Medical management of primary hyperparathyroidism. (Pubmed Central) - Nov 18, 2022 We emphasize the most studied and widely used pharmacological alternatives: bisphosphonates, denosumab, cinacalcet and hormone therapy, in addition to combined therapy. We also address the relevant aspects of perioperative management.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Long-term consequences of osteoporosis therapy with denosumab. (Pubmed Central) - Nov 18, 2022 This review focuses upon prolonged treatment with DMAb, with regard to beneficial effects on fracture reduction and safety. Additionally, its use in patients with impaired renal function, compare its results with those of bisphosphonates (BPs), the occurrence/frequency of complications, in addition to the use of different tools, from imaging techniques to histological findings, to evaluate its effects on bone tissue.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal, Combination therapy: The why and how of sequential and combination therapy in osteoporosis. A review of the current evidence. (Pubmed Central) - Nov 18, 2022 Though data suggests that combining a bisphosphonate with teriparatide does not provide substantial BMD gains compared to monotherapy, the concomitant administration of denosumab with teriparatide has been shown to significantly increase areal BMD as well as to increase volumetric BMD and estimated bone strength. This narrative review explores the available evidence regarding the various sequential and combination therapy approaches and the potential role they could play in better managing osteoporosis.
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