- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Giant Cell Tumor of Bone Presenting as Left Posteromedial Chest Wall Tumor. (Pubmed Central) - Aug 23, 2019
Given its proximity to vital structures in the thoracic cavity, treatment options may be challenging. We report a case of a GCT of the posterolateral chest wall with invasion of the thoracic spine treated with neoadjuvant denosumab followed by surgical resection.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Actonel (risedronate) / Sanofi
Clinical, Journal: "Holidays" for osteoporosis drugs: A case-based approach. (Pubmed Central) - Aug 22, 2019
We report a case of a GCT of the posterolateral chest wall with invasion of the thoracic spine treated with neoadjuvant denosumab followed by surgical resection. •A "drug holiday" can be considered for patients at low fracture risk•It is optimal after completion of five years of alendronate and three years of zoledronic acid or risedronate use•The "drug holiday" strategy should not be implemented for denosumab, estrogen, SERMs or teriparatide.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, odanacatib (MK-0822) / Merck (MSD)
Clinical, Retrospective data, Journal: Vertebral fractures cascade: potential causes and risk factors. (Pubmed Central) - Aug 21, 2019
The results of this retrospective study showed that only half of VFC occurred in patients with a secondary cause of osteoporosis. Prospective studies are needed to further explore the determinants of this severe complication of osteoporosis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: Interstitial Lung Disease in a Patient Treated with Denosumab. (Pubmed Central) - Aug 16, 2019
We present, to our knowledge, the first case report in the English literature of clinically significant interstitial lung disease likely related to denosumab. Denosumab is a fully human monoclonal antibody which may rarely cause interstitial lung disease (ILD).The findings from this isolated case report of ILD in a patient taking denosumab do not prove causality.Nevertheless, we suggest that patient exposure to denosumab should be considered in a patient with ILD.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Current situation and future issues of antiresorptive agent-related osteonecrosis of the jaw (Pubmed Central) - Aug 15, 2019
...In addition, patients treated with denosumab, a human monoclonal antibody against receptor activator of nuclear factor-kappa B ligand (RANKL) whose antiresorptive effects differ from those of BP, may develop osteonecrosis of the jaw...Despite the publication of the first position paper on BRONJ in Japan in 2010, an increase of the number of patients of BRONJ is hypothesized to result from an increase in the long-term use of BP. Previous findings have suggested that inadequate preventive measures including restriction of tooth extraction may be responsible for increases in BRONJ incidence.
- |||||||||| abaloparatide (BA058) / Radius, Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Current Status of Bone-Forming Therapies for the Management of Osteoporosis. (Pubmed Central) - Aug 15, 2019
The BMD response to bone-forming treatment is reduced in patients previously treated with antiresorptive drugs; however, based on the findings of the VERO trial, the anti-fracture efficacy of bone-forming treatment in comparison with antiresorptives seems to be preserved. This review provides an overview of the existing bone-forming therapies for osteoporosis including considerations of sequential and combination therapy.
- |||||||||| Prolia (denosumab) / Amgen
Trial primary completion date: Denosumab In Addition To Intense Urate-Lowering Therapy for Bone Erosions (clinicaltrials.gov) - Aug 11, 2019
P2, N=20, Recruiting,
This review provides an overview of the existing bone-forming therapies for osteoporosis including considerations of sequential and combination therapy. Trial primary completion date: Sep 2019 --> Feb 2020
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Review, Journal: New aspects on giant cell tumor of bone (Pubmed Central) - Aug 11, 2019
Worrisome is the fact that under denosumab therapy a histological change of the lesions can be seen and there are first reports of sarcomas arising after therapy. When diagnosing giant cell-rich lesions, pathologists should be aware of the various differential diagnoses and morphological spectrum within GCTB.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Mild primary hyperparathyroidism-to treat or not to treat? (Pubmed Central) - Aug 11, 2019
Data on normocalcaemic PHPT are lacking. Large-scale randomized controlled trials would be welcome in these areas, however in view of the cost implications a more pragmatic approach may be to develop collaborative multi-centre registries.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Pharmacological treatment for pregnancy and lactation associated osteoporosis. (Pubmed Central) - Aug 11, 2019
There are some reports that show bisphosphonate, teriparatide and/or denosumab are effective on PLO cases. When the patients have wishes for having babies, we have to pay attention if the prescription effect on next pregnancy.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: ASBMR topics from clinical research(osteoporosis and sarcopenia). (Pubmed Central) - Aug 11, 2019
When the patients have wishes for having babies, we have to pay attention if the prescription effect on next pregnancy. There are a lot of progressive topics about osteoporosis and sarcopenia in 2018 ASBMR Annual Meeting, involving an association between diabetes and bone microarchitecture, associations between atypical femoral fractures and bisphosphonate drug holidays as well as pre-treatment bone mineral density, an effect of combined denosumab and high-dose teriparatide on bone parameters, and relationships between muscle and deuterated creatine, a selective androgen receptor modulator, and high-dose vitamin D supplementation.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Retrospective data, Journal: Therapeutic benefits of neoadjuvant and post-operative denosumab on sacral giant cell tumor: a retrospective cohort study of 30 cases. (Pubmed Central) - Aug 9, 2019
There are a lot of progressive topics about osteoporosis and sarcopenia in 2018 ASBMR Annual Meeting, involving an association between diabetes and bone microarchitecture, associations between atypical femoral fractures and bisphosphonate drug holidays as well as pre-treatment bone mineral density, an effect of combined denosumab and high-dose teriparatide on bone parameters, and relationships between muscle and deuterated creatine, a selective androgen receptor modulator, and high-dose vitamin D supplementation. Neoadjuvant therapy with denosumab can significantly relieve the symptoms and neurologic deficits.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Review, Journal: Systematic review of the effect of denosumab on children with osteogenesis imperfect showed inconsistent findings. (Pubmed Central) - Aug 7, 2019
Denosumab is a RANK ligand antibody that prevents RANKL ligand-RANK interaction and inhibits osteoclast formation, thus reducing bone resorption, which has been approved to treat postmenopausal osteoporosis. Its effects on osteoclast may make it suitable for patients with OI and this systematic review summarises the most recent evidence from clinical studies exploring its potential for paediatric OI cases.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Romosozumab (Evenity) for postmenopausal osteoporosis. (Pubmed Central) - Aug 6, 2019
Trial completion date: Feb 2020 --> Feb 2021 | Trial primary completion date: Jul 2019 --> Jul 2020 No abstract available
- |||||||||| Xtandi (enzalutamide) / Pfizer, Astellas, Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Zytiga (abiraterone acetate) / J&J
Clinical, Journal: Optimal Management of Prostate Cancer Based on its Natural Clinical History. (Pubmed Central) - Aug 3, 2019
Osteoclast targeted agents, such as zoledronic acid and denosumab can always been employed, but their use should be limited to the castrate resistant setting. The optimal understanding of all phases characterizing the natural history of prostate cancer may certainly be useful for the selection of the best therapeutic options in prostate cancer.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Denosumab and osteonecrosis of the jaw. (Pubmed Central) - Aug 2, 2019
on behalf of American Society for Bone and Mineral Research. No abstract available
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: Severe hypocalcemia following denosumab treatment in a patient with secondary osteoporosis associated with primary sclerosing cholangitis. (Pubmed Central) - Jul 28, 2019
Even though denosumab treatment had been terminated, the T score of the lumbar spine improved from -4.4 to -2.6 by 1 year after the second administration, possibly due to the amelioration of osteomalacia through the treatment with eldecalcitol and the higher doses of calcium and phosphate. This report indicates that denosumab can cause severe hypocalcemia in patients with osteoporosis associated with chronic diseases of the hepatobiliary system including PSC, in turn suggesting that the possibility of vitamin D deficiency or osteomalacia should be considered before administering treatments and that serum calcium levels should be closely monitored to detect life-threatening hypocalcemia in patients who have high risk factors for hypocalcemia.
- |||||||||| abaloparatide (BA058) / Radius, Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Current and emerging osteoporosis pharmacotherapy for women: state of the art therapies for preventing bone loss. (Pubmed Central) - Jul 26, 2019
Abaloparatide, a parathyroid-hormone-related peptide (PTHrP)-analogue, approved by the FDA in April 2017, constitutes the first new anabolic osteoporosis drug in the US for nearly 15 years and has also proven its anti-fracture efficacy. Romosozumab, a sclerostin inhibitor, which induces bone formation and suppresses bone resorption, has also been developed and shown a significant reduction in fracture incidence; however, concerns have arisen with regard to increased cardiovascular risk.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Osteoporosis: Discontinuing denosumab discouraged. (Pubmed Central) - Jul 24, 2019
Romosozumab, a sclerostin inhibitor, which induces bone formation and suppresses bone resorption, has also been developed and shown a significant reduction in fracture incidence; however, concerns have arisen with regard to increased cardiovascular risk. No abstract available
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: In recent years, bisphosphonates and RANK-ligand inhibitors have become the mainstay of treatment for multiple types of osteoporosis, as well as several other metabolic bone diseases. Although rare, atypical femoral fracture is a recent but clearly defined complication of antiresorptive therapy with bisphosphonates, and likely also with denosumab. In this article, we present 3 different cases of atypical femoral fracture: an incomplete fracture linked to a bisphosphonate, an incomplete fracture linked to denosumab, and a complete atypical femoral fracture. Specific diagnostic steps and therapy are described. We also offer a complete overview of available literature concerning diagnosis, epidemiology, pathogenesis, treatment and future outlooks concerning this entity. Although antiresorptive therapy offers a very significant benefit in the prevention of osteoporotic fractures, clinicians should be aware of the possible complications, especially with long-term therapy. (Pubmed Central) - Jul 24, 2019
...Although rare, atypical femoral fracture is a recent but clearly defined complication of antiresorptive therapy with bisphosphonates, and likely also with denosumab...We also offer a complete overview of available literature concerning diagnosis, epidemiology, pathogenesis, treatment and future outlooks concerning this entity. Although antiresorptive therapy offers a very significant benefit in the prevention of osteoporotic fractures, clinicians should be aware of the possible complications, especially with long-term therapy.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Bone Loss After Romosozumab/Denosumab: Effects of Bisphosphonates. (Pubmed Central) - Jul 19, 2019
In the zoledronate group, mean PINP 6 months post-FRAME was 23 ± 4 µg/L and at 12 months it was 47 ± 8 µg/L, suggesting that repeat zoledronate dosing is needed at 1 year to maintain the BMD gains. In conclusion, delaying administration of intravenous bisphosphonate when transitioning from short-term denosumab appears to increase the extent to which the gains in BMD are maintained.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Review, Journal: Certainties and Uncertainties About Denosumab Discontinuation. (Pubmed Central) - Jul 19, 2019
In conclusion, delaying administration of intravenous bisphosphonate when transitioning from short-term denosumab appears to increase the extent to which the gains in BMD are maintained. No abstract available
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal, PD(L)-1 Biomarker, IO Biomarker: Baseline Absolute Lymphocyte Count and ECOG Performance Score Are Associated with Survival in Advanced Non-Small Cell Lung Cancer Undergoing PD-1/PD-L1 Blockade. (Pubmed Central) - Jul 13, 2019
Neither antibiotic exposure (antibiotic-positive versus antibiotic-negative, HR: 0.90, 95%CI: 0.56-1.45, P = 0.675), nor PD-L1 expression on tumor cells (≥1% versus <1%, HR: 0.68, 95%CI: 0.41-1.13, P = 0.140) was associated with survival. Baseline ECOG performance status and ALC were associated with survival in aNSCLC patients treated with PD-1/PD-L1 inhibitors and assessment of these parameters could be suitable in clinical practice.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Denosumab for bone lesions in multiple myeloma - what is its value? (Pubmed Central) - Jul 11, 2019
Baseline ECOG performance status and ALC were associated with survival in aNSCLC patients treated with PD-1/PD-L1 inhibitors and assessment of these parameters could be suitable in clinical practice. No abstract available
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