- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Retrospective data, Journal: Pharmacological Therapies for Osteoporosis: A Bayesian Network Meta-Analysis. (Pubmed Central) - Apr 19, 2022
Finally, the use of bazedoxifene was associated with the highest incidence of any upper-gastrointestinal event, nasopharyngitis, and back pain, while risedronate was associated with higher incidence of abdominal pain and dyspepsia. CONCLUSIONS This study found that romosozumab yielded the best effects for preventing fracture risk, while abaloparatide was the most effective in reducing the risk of vertebral fracture and non-vertebral fracture.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Drug therapy for osteoporosis in older adults. (Pubmed Central) - Apr 7, 2022
Denosumab is administered by subcutaneous injection every 6 months...Romosozumab is an anti-sclerostin monoclonal antibody that stimulates bone formation and inhibits resorption...The effects of anabolic agents are transient, so transition to anti-resorptive drugs is required. The optimal strategy for cycling anabolics, anti-resorptives, and off-treatment periods remains to be determined.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment open: Anabolic Therapy in Postmenopausal Osteoporosis (clinicaltrials.gov) - Apr 1, 2022
P4, N=46, Recruiting,
Romosozumab may significantly increase BMD regardless of the addition of an active vitamin D analog. Not yet recruiting --> Recruiting
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Endocrinology of bone mineralization: an update. (Pubmed Central) - Mar 23, 2022
Diagnosis is based on clinical history, phosphocalcic metabolism assessment and, if necessary, molecular characterization, and must be rapid in order to initiate the most appropriate treatment and consider new treatments such as burosumab if necessary...The question of treatment sequencing in osteoporosis is another challenge, notably after denosumab cessation, complicated by a decrease in bone mineral density and increased risk of fracture...New treatments are also available, including romosozumab, a humanized monoclonal antibody which promotes bone formation and inhibits bone resorption by inhibiting sclerostin. Romosozumab is approved in several countries, including France, for treating severe osteoporosis in postmenopausal women at high risk of fracture and free of cardiovascular comorbidity.Endocrinologists need to be aware of these fragilizing osteopathies in order to improve both diagnosis and treatment.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Romosozumab in Postmenopausal Korean Women with Osteoporosis: A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study. (Pubmed Central) - Mar 15, 2022
P3
Romosozumab is approved in several countries, including France, for treating severe osteoporosis in postmenopausal women at high risk of fracture and free of cardiovascular comorbidity.Endocrinologists need to be aware of these fragilizing osteopathies in order to improve both diagnosis and treatment. Treatment with romosozumab for 6 months was well tolerated and significantly increased lumbar spine, total hip, and femoral neck BMD compared with placebo in Korean postmenopausal women with osteoporosis (ClinicalTrials.gov identifier NCT02791516).
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Modeling-Based Bone Formation After 2 Months of Romosozumab Treatment: Results From the FRAME Clinical Trial. (Pubmed Central) - Mar 15, 2022
P3
Participants in the bone biopsy substudy received quadruple tetracycline labeling and underwent transiliac biopsies at month 2...After 2 months, the median percentage of MBBF referent to the total bone surface was significantly increased with romosozumab vs placebo on cancellous (18.0% vs 3.8%; p =?0.005) and endocortical (36.7% vs 3.0%; p =?0.001), but not on periosteal (5.0% vs 2.0%; p =?0.37) surfaces, with no significant difference in the surface extent of RBBF on all three bone surfaces. These data show that stimulation of bone formation in the first 2 months of romosozumab treatment in postmenopausal women with osteoporosis is predominately due to increased MBBF on endocortical and cancellous surfaces.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Circulating sclerostin levels are positively related to coronary artery disease severity and related risk factors. (Pubmed Central) - Mar 15, 2022
Romosozumab is a newly available treatment for osteoporosis acting by sclerostin inhibition...Associations with cardiac mortality and coronary artery severity were partially attenuated after adjustment for risk factors potentially related to sclerostin, namely LDL and HDL cholesterol, log triglycerides, DM, hypertension, eGFR and Apolipoprotein A-I. Contrary to trial evidence suggesting sclerostin inhibition leads to an increased risk of CVD, sclerostin levels appear to be positively associated with CAD severity and mortality, partly explained by a relationship between higher sclerostin levels and major CVD risk factors.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Romosozumab enhances vertebral bone structure in women with low bone density. (Pubmed Central) - Mar 15, 2022
Cortical maps showed the topographical locations of the increase in bone in fracture-prone areas of the vertebral shell, walls and endplates. This study confirms widespread vertebral bone accrual with romosozumab or teriparatide treatment, and provides new insights into how the rapid prevention of vertebral fractures is achieved in women with osteoporosis using these anabolic agents.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Romosozumab Reduces Incidence of New Vertebral Fractures Across Severity Grades Among Postmenopausal Women with Osteoporosis. (Pubmed Central) - Mar 12, 2022
P3
Reductions in the incidence of new moderate and severe VFs were sustained through 24 months, after transition from romosozumab to denosumab or alendronate, independent of baseline VF prevalence or severity; no significant interactions were observed between the incidence of new moderate-or-severe VFs and the presence of prevalent (FRAME; p=0.81) or severe (ARCH; p=0.99) VFs at baseline. With increasing recommendations for initial treatment with bone-forming agents for postmenopausal women with osteoporosis, these analyses will help to inform treatment decisions for patients at very high risk of VF.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB, setrusumab (BPS804) / Novartis, MorphoSys, Mereo Biopharma, blosozumab (LY2541546) / Eli Lilly
Review, Journal: Sclerostin Inhibition: A Novel Target for the Treatment of Postmenopausal Osteoporosis. (Pubmed Central) - Mar 11, 2022
Its efficacy and safety have been established in trials. However, patients at high risk of cardiovascular or cerebrovascular events should not be prescribed romosozumab.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Biomarker, Journal: Advances in Bone Turnover Markers (PINP and CTX) in Optimizing Anti-resorptive and Anabolic Therapies Against Osteoporosis. (Pubmed Central) - Mar 8, 2022
The numerical changes and clinical significance of BTMs in two therapies are summarized and the practical application and potential value of PINP and CTX as therapeutic target, threshold of follow-up therapy, and evaluation of fracture risk in different regimes such as bisphosphonates, denosumab, raloxifene, teriparatide, abaloparatide, and romosozumab are reviewed in this paper. The application of BTMs is expected to improve the efficacy of the treatments and reduce the rate of osteoporotic fracture in clinical practice.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Risks vs. benefits of switching therapy in patients with postmenopausal osteoporosis. (Pubmed Central) - Jan 29, 2022
We recommend first using osteoanabolic agents in postmenopausal women with severe osteoporosis. In addition, identifying predictors of the efficacy and side effects of treatment may help prevent the inappropriate use of drugs for the treatment of osteoporosis.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Efficacy of Romosozumab for Osteoporosis in a Patient With Osteogenesis Imperfecta: A Case Report. (Pubmed Central) - Jan 27, 2022
Neither hypocalcemia nor any other severe adverse effects were observed in this severe osteoporotic case. This study revealed good responses of BMD and bone turnover markers to romosozumab treatment, which can be considered as an effective treatment option for osteoporotic OI patients.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Review, Journal: Bone Mineral Density Loss and Fracture Risk After Discontinuation of Anti-osteoporotic Drug Treatment: A Narrative Review. (Pubmed Central) - Jan 27, 2022
Therefore, in modern fracture risk management, continuous monitoring and treatment is required, as is the case with other chronic diseases, to sustain the benefits of therapy, especially in denosumab- and romosozumab-treated patients. The exception is alendronate and zoledronic acid, in these patients a discontinuation of drug therapy of 1 year or more might be acceptable.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Retrospective data, Review, Journal: A systematic review and meta-analysis of efficacy and safety of Romosozumab in postmenopausal osteoporosis. (Pubmed Central) - Jan 18, 2022
The total adverse events [RR = 0.98(95%CI = 0.96-1.01), Moderate quality] and serious adverse events [RR = 0.98(95%CI = 0.88-1.08), Moderate quality] with romosozumab were comparable to the control group. The current analysis with evidence on efficacy and safety of Romosozumab, authors opine to recommend the use of Romosozumab treatment for post-menopausal osteoporosis.Systematic review registration: PROSPERO registration number: CRD42019112196.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB, Edirol (eldecalcitol) / Roche, Taisho
Journal: Histochemical characteristics on minimodeling-based bone formation induced by anabolic drugs for osteoporotic treatment. (Pubmed Central) - Jan 14, 2022
The histological characteristics of minimodeling-based bone formation is quite different from remodeling, as it is not related to osteoclastic bone resorption, resulting in convex-shaped new bone and smooth cement lines called arrest lines. In this review, we will show histological properties of minimodeling-based bone formation by osteoporotic drugs.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Trial completion date, Trial primary completion date: Romosozumab in Women With Chronic SCI (clinicaltrials.gov) - Jan 5, 2022
P2, N=12, Recruiting,
In this review, we will show histological properties of minimodeling-based bone formation by osteoporotic drugs. Trial completion date: Apr 2024 --> Feb 2025 | Trial primary completion date: Mar 2023 --> Sep 2024
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Anabolic Agents for Postmenopausal Osteoporosis: How Do You Choose? (Pubmed Central) - Jan 1, 2022
There is no definitive answer to this question; all three agents increase bone strength and reduce fracture risk rapidly. Since the postmenopausal lifespan could be as long as 40-50 years, it is likely that very high-risk women will utilize different anabolic agents at different points in their lives.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Review, Journal: Romosozumab: a Review of Efficacy, Safety, and Cardiovascular Risk. (Pubmed Central) - Dec 18, 2021
Until more real-world evidence is available, romosozumab should not be used in patients with a recent cardiovascular event and should be used cautiously in patients with high cardiovascular risk. Romosozumab's place in therapy is likely patients with severe postmenopausal osteoporosis and low cardiovascular risk.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Preclinical, Journal: Teriparatide and Abaloparatide Have a Similar Effect on Bone in Mice. (Pubmed Central) - Dec 18, 2021
Three bone anabolic pharmaceuticals are currently approved for treatment of osteoporosis, teriparatide (PTH (1-34)), the parathyroid hormone-related protein analog abaloparatide (ABL), and romosozumab...Neither PTH nor ABL significantly increased bone strength at the femoral neck. In conclusion, abaloparatide and PTH have similar bone anabolic properties when compared directly mole-to-mole in mice.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Postmenopausal osteoporosis: risk evaluation and treatment options. (Pubmed Central) - Dec 16, 2021
From the literature it emerges that menopausal hormone therapy (MHT), TSEC combination and SERMs can be drugs of choice to counteract postmenopausal bone loss in younger women or at low risk of fracture, while bisphosphonates and denosumab are appropriate for women with high risk or at an older age. Therapy with denosumab and anabolic agents such as teriparatide and romosozumab is particularly indicated for subjects with very high risk of fracture.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: ▼Romosozumab for osteoporosis. (Pubmed Central) - Dec 16, 2021
Generic name: RomosozumabBrand name: EvenityFormulation: 105 mg solution for injection in a pre-filled penMarket Authorisation holder: UCB Pharma LimitedIndication: treatment of severe osteoporosis in postmenopausal women at high risk of fractureDose: 210 mg romosozumab (administered as two subcutaneous injections of 105 mg each) once a month for 12 months. It is recommended that patients begin antiresorptive therapy after completing treatment with romosozumab.Cost: £427.75 for two pre-filled pens each containing 105 mg romosozumabClassification: Prescription only medicine (POM) subject to additional monitoring (▼).
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Romosozumab in the treatment of osteoporosis. (Pubmed Central) - Dec 2, 2021
In clinical trials, it has proven to be superior to other agents in terms of increasing bone mineral density and reducing the incidence of fractures. This review will highlight the pharmacology, clinical efficacy and safety profile of romosozumab and suggest where this medication may fit within our current management of osteoporosis.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: The Role of Novel Bone Forming Agents in the Treatment of Osteoporosis. (Pubmed Central) - Nov 29, 2021
Currently, the National Osteoporosis Foundation (NOF) has no formal recommendations in regard to these 2 novel agents. The purpose of this review is to help guide pharmacists on how to ensure appropriate utilization of these 2 novel bone-forming agents as potential alternatives to bisphosphonate therapy by providing evidence-based recommendations according to the current literature and key counseling points.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Review, Journal: Cardiovascular Safety of Anti-Sclerostin Therapy in Chronic Kidney Disease. (Pubmed Central) - Nov 29, 2021
Limited clinical evidence suggests that the osteoanabolic and anti-resorptive activity is attenuated, but hypocalcemia is more prevalent in patients with advanced CKD (eGFR < 30 mL/min) treated with anti-sclerostin (romosozumab) therapy as compared to patients without kidney disease...Whether the inhibition of sclerostin has adverse effects on cardiovascular health in CKD is currently unknown. This review summarizes the current understanding of the physiology and pathophysiology of sclerostin in CKD, with a focus on the cardiovascular safety of anti-sclerostin therapy in patients with or without CKD.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Denosumab versus romosozumab for postmenopausal osteoporosis treatment. (Pubmed Central) - Nov 24, 2021
Adverse events were few and predominantly minor in both groups, with no remarkable difference in the incidence of new vertebral fractures. Romosozumab showed a higher potential for improving BMD than denosumab in this clinical study of postmenopausal osteoporosis patient treatment.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment change: Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa (clinicaltrials.gov) - Nov 22, 2021
P3, N=30, Recruiting,
Romosozumab showed a higher potential for improving BMD than denosumab in this clinical study of postmenopausal osteoporosis patient treatment. N=75 --> 30
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Romosozumab Followed by Antiresorptive Treatment Increases the Probability of Achieving Bone Mineral Density Treatment Goals. (Pubmed Central) - Nov 16, 2021
N=75 --> 30 Here, we compare the probability of achieving a T-score of > -2.5 over 3 years at the total hip (TH) or lumbar spine (LS) in women with osteoporosis, ≥55 years of age, after the following treatment sequences: 1 year romosozumab followed by 2 years denosumab (FRAME and FRAME extension trials), 1 year romosozumab followed by 2 years alendronate, or alendronate-only for 3 years (ARCH trial).
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Romosozumab: A Novel Agent in the Treatment for Postmenopausal Osteoporosis. (Pubmed Central) - Nov 10, 2021
Romosozumab should be reserved for postmenopausal women at highest risk for fracture and should be followed by an anti-resportive agent to maintain or further increase bone mineral density. This injectable agent should not be considered for women with a history of or at high risk of cardiovascular disease.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Update on Osteoporosis Screening and Management. (Pubmed Central) - Nov 6, 2021
Pharmacologic agents should be recommended in postmenopausal women who are at high risk for fractures. Newer anabolic therapies including teriparatide, abaloparatide, and romosozumab have emerged for use in severe osteoporosis.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Preclinical, Journal: Sclerostin Depletion Induces Inflammation in the Bone Marrow of Mice. (Pubmed Central) - Oct 29, 2021
Romosozumab, a humanized monoclonal antibody specific for sclerostin (SOST), has been approved for treatment of postmenopausal women with osteoporosis at a high risk for fracture...Additionally, we observed alterations in erythrocyte differentiation in the BM and spleen of Sost mice. Taken together, our current study indicates novel roles for Sost in the regulation of myelopoiesis and control of inflammation in the BM.
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