- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Role of bone-forming agents in the management of osteoporosis. (Pubmed Central) - May 4, 2021
Recent evidence confirms the superiority of osteoanabolic therapy compared to anti-remodeling drugs for rapid improvement in bone density and fracture risk reduction, providing strong justification for the use of these anabolic agents as the initial therapy in high-risk patients, to be followed by anti-remodeling therapy. This review will highlight the results of recent studies and define the current status of osteoanabolic therapy for osteoporosis.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Romosozumab : a new treatment for severe osteoporosis (Pubmed Central) - Apr 28, 2021
The increase in bone mineral density is higher with romosozumab as compared to teriparatide in patients previously treated with alendronate. The use of romosozumab (Evenity) is admitted for patients with high risk of fractures but without serious vascular events.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Romosozumab followed by denosumab in Japanese women with high fracture risk in the FRAME trial. (Pubmed Central) - Apr 10, 2021
It is especially effective in patients with low baseline spine BMD, high TRACP-5b, and high iP1NP. Romosozumab/denosumab in Japanese subjects at high risk of fracture resulted in significant BMD gains and numerically lower vertebral fracture rate vs. placebo/denosumab at all timepoints measured.
- |||||||||| Strensiq (asfotase alfa) / Alexion Pharma, Evenity (romosozumab) / Astellas, Amgen, UCB, Crysvita (burosumab) / Ultragenyx, Kyowa Hakko Kirin
Journal: New therapeutic options for bone diseases. (Pubmed Central) - Apr 7, 2021
The sclerostin antibody romosozumab is the most recently approved drug for the therapy of postmenopausal osteoporosis...For rare bone diseases such as X‑linked hypophosphatemia (XLH) and hypophosphatasia (HPP), specific therapies are now also available, showing promising data in children and adults with a severe disease course. However, long-term data are needed to assess a sustained benefit for patients.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
[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.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Nonclinical cardiovascular safety evaluation of romosozumab, an inhibitor of sclerostin for the treatment of osteoporosis in postmenopausal women at high risk of fracture. (Pubmed Central) - Mar 26, 2021
P3
Although pharmacodynamic effects were observed in the bone, there were no functional, morphological, or transcriptional effects on the cardiovascular system in animal models in the presence or absence of atherosclerosis. These nonclinical studies did not identify evidence that proves the association between sclerostin inhibition and adverse cardiovascular function, increased cardiovascular calcification, and atheroprogression.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, P3 data, Journal: Romosozumab or alendronate for fracture prevention in East Asian patients: a subanalysis of the phase III, randomized ARCH study. (Pubmed Central) - Mar 12, 2021
Additional studies of patients at higher risk for delayed healing are needed to explore the potential of romosozumab to accelerate tibial fracture-healing. Consistent with the global analysis, romosozumab followed by alendronate was associated with lower incidences of new vertebral, clinical, non-vertebral, and hip fractures vs alendronate alone among East Asian patients.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Laser irradiation decreases sclerostin expression in bone and osteogenic cells. (Pubmed Central) - Mar 12, 2021
Anti-sclerostin monoclonal antibody romosozumab, a treatment for osteoporosis, reduced vertebral fracture risk and clinical fracture...Only bur-drilled bone showed enriched inflammation-related gene sets and pathways at 24 hours, not in the laser-ablated bone. Our study suggests that laser irradiation may become a new treatment modality for osteoporosis, by inhibiting sclerostin expression without inducing inflammation.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Review, Journal: Osteoporosis Treatment with Anti-Sclerostin Antibodies-Mechanisms of Action and Clinical Application. (Pubmed Central) - Mar 7, 2021
We review clinical studies of romosozumab in terms of bone mass accrual and anti-fracture activity in the setting of postmenopausal and male osteoporosis, present sequential treatment regimens, and discuss its safety profile and possible limitations in its use. Moreover, an outlook comprising future translational applications of anti-sclerostin antibodies in diseases other than osteoporosis is given, highlighting the clinical significance and future scopes of Wnt signaling in these settings.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment open: Romosozumab in Women With Chronic SCI (clinicaltrials.gov) - Mar 4, 2021
P2, N=12, Recruiting,
Moreover, an outlook comprising future translational applications of anti-sclerostin antibodies in diseases other than osteoporosis is given, highlighting the clinical significance and future scopes of Wnt signaling in these settings. Not yet recruiting --> Recruiting
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
[VIRTUAL] Treatment of Osteoporosis Related to Adult Hypophosphatasia () - Feb 21, 2021 - Abstract #CRAAHPA2021CRA-AHPA_183;
Discussion In patients with HPP-related osteoporosis, case reports have described increased bone formation and decreased bone pain with anabolic treatment modalities (teriparatide or romosozumab)...In our case, we have used denosumab following a course of teriparatide. Ongoing research and monitoring is required to assess long-term safety and efficacy.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
[VIRTUAL] Temporal Trends in Prescribing of Bone-Directed Therapies in the United States, 2009-2020 (On-Demand) - Feb 2, 2021 - Abstract #ENDO2021ENDO_829;
Use of teriparatide, abaloparatide, and romosozumab remained less than 2% throughout the study period...In the malignancy cohort, alendronate and zoledronic acid were each used in approximately 30% of individuals at the onset of the study, and both declined over the decade...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.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
[VIRTUAL] Faculty (On-Demand) - Feb 2, 2021 - Abstract #ENDO2021ENDO_63;
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.
- |||||||||| Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment open, Trial completion date: Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users (clinicaltrials.gov) - Feb 2, 2021
P4, N=72, Recruiting,
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. Not yet recruiting --> Recruiting | Trial completion date: Oct 2024 --> Apr 2024
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Journal: Osteoporosis: Novel drug, new recommendations (Pubmed Central) - Jan 30, 2021
Regarding denosumab, several studies indicate that post-treatment bone loss may be, at least partially, prevented by zoledronate. Finally, monitoring BMD changes and the T-score reached on any therapy could be used as an indicator of anti-fracture efficacy.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Romosozumab: A Review in Postmenopausal Osteoporosis. (Pubmed Central) - Jan 23, 2021
Romosozumab had a generally manageable tolerability profile. While further clinical experience is needed to more definitively establish its efficacy and safety, including its CV safety, romosozumab extends the treatment options in postmenopausal women with osteoporosis who have a high risk of fracture and in those who have failed or are intolerant to other available osteoporosis therapy.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Anabolic Therapy and Optimal Treatment Sequences for Patients With Osteoporosis at High Risk for Fracture. (Pubmed Central) - Jan 22, 2021
While further clinical experience is needed to more definitively establish its efficacy and safety, including its CV safety, romosozumab extends the treatment options in postmenopausal women with osteoporosis who have a high risk of fracture and in those who have failed or are intolerant to other available osteoporosis therapy. This review defines the highest-risk patients and summarizes the rationale for the evolving role of anabolic therapy in the management of postmenopausal women at high risk for fracture.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Journal: The Basics of Bone Physiology, Healing, and Osteoporosis. (Pubmed Central) - Jan 21, 2021
Anabolic agents such as teriparatide, abaloparatide, and romosozumab stimulate osteoblastic differentiation and bone formation. All these agents are effective in reducing fracture risk.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Journal: Osteoporosis: Current and emerging therapies targeted to immunological checkpoints. (Pubmed Central) - Jan 15, 2021
Currently, there are basically two monoclonal antibodies for osteoporosis therapy: denosumab and romosozumab. Here we focus on the modern approach to the osteoporosis management and in particular on current and developing biologic drugs targeted to new immunological checkpoints, in the landscape of osteoimmunology.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Sclerostin antibody stimulates periodontal regeneration in large alveolar bone defects. (Pubmed Central) - Jan 13, 2021
Romosozumab, approved by the FDA in 2019, is a humanized sclerostin-neutralizing antibody (Scl-Ab) indicated in postmenopausal women with osteoporosis at high risk for fracture...Systemic Scl-Ab administration improved bone regeneration and tended to increase cementogenesis measured by histology and microcomputed tomography, while Scl-Ab delivered by MSs did not result in enhancements in bone or cemental repair compared to MSs alone or control. In conclusion, systemic administration of Scl-Ab promotes bone and cemental regeneration while local, low dose delivery did not heal periodontal osseous defects in this study.
- |||||||||| Journal: Antibodies to watch in 2020. (Pubmed Central) - Jan 9, 2021
P3
Of the 79 antibodies in late-stage studies, 40 were undergoing evaluation as treatments for cancer, and potentially 9 of these (belantamab mafodotin, oportuzumab monatox, margetuximab, dostarlimab, spartalizumab, 131I-omburtamab, loncastuximab tesirine, balstilimab, and zalifrelimab) may enter regulatory review in late 2019 or in 2020. Overall, the biopharmaceutical industry's clinical pipeline of antibody therapeutics is robust, and should provide a continuous supply of innovative products for patients in the future.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Journal: Dynamics of Bone Cell Interactions and Differential Responses to PTH and Antibody-Based Therapies. (Pubmed Central) - Jan 8, 2021
The main attributes of each disease are qualitatively well captured by the model, for example changes in bone turnover in the disease states. We explored dosing regimens for each disease based on the combination of denosumab and romosozumab, identifying adequate ratios and doses of both drugs for subpopulations of patients in function of categories of osteoporosis and the degree of severity of the disease.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: New Targets and Emergent Therapies for Osteoporosis. (Pubmed Central) - Dec 18, 2020
As the genomic revolution continues, potential novel targets for future drug development are identified. This review takes a wide perspective to describe potentially rewarding topics to explore, including knowledge of genes and pathways involved in bone cell metabolism, the utility of animal models, targeting drugs to bone, and ongoing advances in drug design and delivery.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Osteoporosis Therapeutics 2020. (Pubmed Central) - Dec 18, 2020
In this chapter, we give first an overview of the most important outcomes regarding fracture risk reduction, change in bone mineral density (BMD by DXA) and/or bone markers of the phase III clinical studies of well-established therapies (such as Bisphosphonates, Denosumab or Teriparatide) and also novel therapies (such as Romosozumab or Abaloparatide) and highlight their mechanisms of action at bone tissue/material level...In the second part of this chapter, we focus on the management of different forms of osteoporosis and give a review of the respective current guidelines for treatment. Adverse effects of treatment such as atypical femoral fractures, osteonecrosis of the jaw or influence of fracture healing are considered also in this context.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: New Frontiers in Osteoporosis Therapy. (Pubmed Central) - Nov 28, 2020
New approaches now in clinical use include the antisclerostin monoclonal antibody romosozumab, as well as the parathyroid hormone-related peptide analog abaloparatide...Expected final online publication date for the Annual Review of Medicine, Volume 71 is January 27, 2020. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Guideline Update. (Pubmed Central) - Nov 12, 2020
We reviewed findings from the meta-analysis and primary clinical trials assessing the efficacy of romosozumab, a monoclonal antibody targeting sclerostin, for the prevention of fractures and concluded that this agent can be considered a treatment option for postmenopausal women at very high risk for osteoporotic fracture. The romosozumab label has a boxed warning, recommending careful consideration by the treating clinician as to cardiovascular risk profile in the individual woman who might receive this agent, since clinical trial data from an active comparator study show an imbalance in serious cardiovascular adverse events between romosozumab and alendronate.
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