- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
[VIRTUAL] Abstracts: Osteoporosis & Metabolic Bone Disease () - Nov 11, 2020 - Abstract #ACRARHP2020ACR_ARHP_3450;
In patients treated with Aln or DMAb, transition to Romo can improve BMD, though gains are not as large as those seen when Romo is used first. Since BMD on treatment is a strong surrogate for bone strength, our findings support the concept that high-risk patients should be offered treatment with Romo first, followed by transition to a potent antiresorptive
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
[VIRTUAL] Osteoporosis & Metabolic Bone Disease Poster () - Nov 11, 2020 - Abstract #ACRARHP2020ACR_ARHP_3362;
P2
BMD response in the placebo to romosozumab group was similar to that observed in other studies. Transitioning to romosozumab after 12 months of denosumab further improves lumbar spine BMD and maintains total hip BMD.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Anti-Sclerostin Antibodies in Osteoporosis and Other Bone Diseases. (Pubmed Central) - Nov 1, 2020
Therefore, romosozumab was recently approved in several countries for the treatment of severe osteoporosis in postmenopausal women with high fracture risk and without a history of heart attack, myocardial infarction or stroke. This review aims to outline the role of sclerostin, the efficacy and safety of anti-sclerostin therapies and in particular romosozumab and their place in therapeutic strategies against osteoporosis or other bone diseases.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Which Drug Next? Sequential Therapy for Osteoporosis. (Pubmed Central) - Oct 30, 2020
The article by Kendler et al. in this issue of JCEM reports alendronate preserves bone accrued during administration of denosumab.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: New Osteoporosis Treatment Means New Bone Formation. (Pubmed Central) - Oct 27, 2020
It has been approved for use in postmenopausal women at greater risk for bone fracture. Romosozumab-aqqg is administered once monthly in injection form for 12 consecutive months.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
[VIRTUAL] Treatment Sequences with Romosozumab Before or After Antiresorptive Medication (Feed 12) - Oct 8, 2020 - Abstract #ACRARHP2020ACR_ARHP_2736;
In patients treated with Aln or DMAb, transition to Romo can improve BMD, though gains are not as large as those seen when Romo is used first. Since BMD on treatment is a strong surrogate for bone strength, our findings support the concept that high-risk patients should be offered treatment with Romo first, followed by transition to a potent antiresorptive
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB, zoledronic acid / Generic mfg.
Journal: Controversies in the treatment of postmenopausal osteoporosis: How long to treat with bisphosphonates? (Pubmed Central) - Oct 4, 2020
Until a risk calculator for predicting risk of atypical fractures, becomes available in clinical practice, and we view this as an unlikely scenario, it is up to the physician to consider continuing or discontinuing bisphosphonate use after the critical 3-5 year period of treatment with zoledronic acid or alendronate, but close monitoring for the residual bone effects overtime should be planned. For other bisphosphonates, in which no residual effects are expected, drug holiday is usually not applied.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Romosozumab: a novel bone anabolic treatment option for osteoporosis? (Pubmed Central) - Sep 26, 2020
In Japan, South Korea, Canada, Australia, and the USA, osteoporosis patients at a high risk of fracture may already be treated with romosozumab (Evenity). Approval in the European Union was granted by 2019-12-12.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Pharmacological Therapy of Osteoporosis: What's New? (Pubmed Central) - Sep 20, 2020
In particular, abaloparatide has been demonstrated to reduce major nonvertebral fracture risk compared with both placebo and teriparatide, although the European Medicines Agency (EMA) refused the marketing authorization because the benefits of this drug did not outweigh its risks. On the other side, EMA has recently approved romosozumab, a monoclonal antibody directed against sclerostin and the only available therapeutic option targeting Wnt signaling, as both bone-forming and antiresorptive intervention to treat osteoporosis and fragility fractures.
- |||||||||| Review, Journal: Comparison table: some drugs for postmenopausal osteoporosis. (Pubmed Central) - Sep 20, 2020
On the other side, EMA has recently approved romosozumab, a monoclonal antibody directed against sclerostin and the only available therapeutic option targeting Wnt signaling, as both bone-forming and antiresorptive intervention to treat osteoporosis and fragility fractures. No abstract available
- |||||||||| Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Trial completion date, Trial initiation date, Trial primary completion date: Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users (clinicaltrials.gov) - Sep 7, 2020
P4, N=72, Not yet recruiting,
No abstract available Trial completion date: Apr 2024 --> Oct 2024 | Initiation date: Jul 2020 --> Dec 2020 | Trial primary completion date: Jul 2023 --> Dec 2023
- |||||||||| Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim, Evenity (romosozumab) / Astellas, Amgen, UCB, Rinvoq (upadacitinib) / AbbVie
Journal: Romosozumab-aqqg, upadacitinib, and risankizumab-rzaa. (Pubmed Central) - Sep 4, 2020
Trial completion date: Apr 2024 --> Oct 2024 | Initiation date: Jul 2020 --> Dec 2020 | Trial primary completion date: Jul 2023 --> Dec 2023 No abstract available
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Romosozumab and Sequential Therapy in Postmenopausal Osteoporosis. (Pubmed Central) - Sep 1, 2020
An evaluation of studies where romosozumab was used in sequence to other therapies in PMP women showed that it causes significant reductions in bone resorption markers, increases in bone-formation markers, improves BMD, and reduces the risk of clinical fracture. However, these efficacy improvements must be carefully weighed against the increased risk of cardiovascular adverse effects compared with other treatments.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Review, Journal: Osteoporosis in Older Adults. (Pubmed Central) - Aug 20, 2020
Bisphosphonates are a first-line therapy for many patients with osteoporosis. Other treatments for osteoporosis include denosumab, teriparatide, abaloparatide, romosozumab, and selective estrogen receptor modulators.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
[VIRTUAL] Osteoporosis: An Overview (Feed 1) - Aug 16, 2020 - Abstract #ACRARHP2020ACR_ARHP_501;
Other treatments for osteoporosis include denosumab, teriparatide, abaloparatide, romosozumab, and selective estrogen receptor modulators. Learning Objectives: Present a review of current data on osteoporosis treatments, including anabolic therapy, denosumab and "drug holidays" Describe the mechanism of action and use of romosozumab Discuss regimens of combination and sequential osteoporosis treatments Discuss the presentations of hypophosphatasia in rheumatology practice, including diagnosis and management
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Preclinical, Journal: Inverse correlation between trabecular bone volume and bone marrow adipose tissue in rats treated with osteoanabolic agents. (Pubmed Central) - Jul 21, 2020
Sclerostin-neutralizing antibodies (Scl-Ab), romosozumab, human parathyroid hormone (hPTH, 1-34), and hPTH/hPTHrP analogues (e.g. teriparatide and abaloparatide) stimulate bone formation and have been studied in clinical trials for severe osteoporosis...Thus, researchers should consider which adiposity measurement is more informative and relevant for their studies. Overall, our findings should help design improved therapies or combination treatments to target a potential new contributor to bone diseases: the bone marrow adipocyte.
- |||||||||| Retrospective data, Journal: Comparative efficacy and safety of pharmacological interventions for osteoporosis in postmenopausal women: a network meta-analysis (Chongqing, China). (Pubmed Central) - Jul 16, 2020
Meanwhile, there is no statistical difference between abaloparatide, teriparatide or romosozumab, and placebo in terms of safety. Furthermore, in terms of adverse events, zoledronic acid is statistically worse than placebo, and two of the best interventions are denosumab and romosozumab, of which denosumab also reduces the risk of different kinds of fractures.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions: Results of the FRAME Extension Study. (Pubmed Central) - Jul 11, 2020
Furthermore, in terms of adverse events, zoledronic acid is statistically worse than placebo, and two of the best interventions are denosumab and romosozumab, of which denosumab also reduces the risk of different kinds of fractures. The sequence of romosozumab followed by denosumab may be a promising regimen for the treatment of osteoporosis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Biomarker, Journal: Osteoporosis Management in the Era of COVID-19. (Pubmed Central) - Jul 1, 2020
Particular emphasis is placed on the transition from parenteral osteoporosis therapies. It is hoped that these recommendations can be used to safely guide care for patients with osteoporosis until a return to routine clinical care standards is available.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Novel therapies in osteoporosis: PTH-related peptide analogues and inhibitors of sclerostin. (Pubmed Central) - Jun 20, 2020
Romosozumab is a monoclonal antibody that targets the Wnt inhibitor sclerostin...Based on these results, abaloparatide was FDA approved in April 2017. This review discusses available data of both agents with regard to efficacy and safety as well as their possible future concomitant application to current treatment options.
- |||||||||| Review, Journal: Osteoporosis, bone mineral density and CKD-MBD (II): Therapeutic implications. (Pubmed Central) - May 9, 2020
Post-hoc analyses of randomised studies have shown that the efficacy of drugs such as alendronate, risedronate, raloxifene, teriparatide and denosumab is similar to that of the general population in patients with a mild/moderate decline in their glomerular filtration rate (especially CKD-3)...However, we must also be aware that most studies are not consistent and the level of evidence is low. Consequently, any pharmacological intervention (risk/benefit) should be prudent and individualised.
- |||||||||| Review, Journal: Treating osteoporosis to prevent fractures: current concepts and future developments. (Pubmed Central) - May 7, 2020
For patients with severe osteoporosis and high fracture risk, bisphosphonates alone are unlikely to be able to provide long-term protection against fracture and restore BMD. For those patients, sequential treatment, starting with a bone-building drug (e.g. teriparatide), followed by an antiresorptive, will likely provide better long-term fracture prevention and should be the golden standard of future osteoporosis treatment.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: The evolving role of anabolic therapy in the treatment of osteoporosis. (Pubmed Central) - May 7, 2020
Studies comparing treatment sequences with anabolic and antiresorptive treatments are also summarized. High-risk patients who should be considered for initial treatment with anabolic medication are defined.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB, zoledronic acid / Generic mfg.
Clinical, Journal: Combination and sequential treatment in women with postmenopausal osteoporosis. (Pubmed Central) - May 6, 2020
Combination therapy with teriparatide and denosumab or zoledronate has achieved higher BMD gains compared to each agent alone; however, due to the high cost, combination therapy is rarely compensated. On the contrary, the combination of teriparatide with alendronate results in smaller BMD increases than TPTD monotherapy.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Bones, heart and the new anabolic agent romosozumab. (Pubmed Central) - Apr 29, 2020
Restoring the abnormal signal network and individualized therapy are critical for the ideal drug development. No abstract available
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