- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Osteoanabolic and Dual Action Drugs. (Pubmed Central) - Apr 15, 2020
Romosozumab, a monoclonal antibody that binds to and inhibits sclerostin, appears to have dual actions by stimulating bone formation and reducing bone resorption. In the pivotal clinical trial, romosozumab, administered as a 210 mg monthly subcutaneous dose, significantly reduced new vertebral fractures and in a subsequent study reduced both vertebral and non-vertebral fractures.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB, blosozumab (LY2541546) / Eli Lilly
Review, Journal: Pharmacometrics and Systems Pharmacology for Metabolic Bone Diseases. (Pubmed Central) - Apr 14, 2020
This review provides an overview of several M&S approaches ranging from simple pharmacokinetic to integrated pharmacometric and systems pharmacology modeling. Examples are included to illustrate the use of these approaches during the development of several drugs for metabolic bone diseases such as bisphosphonates, denosumab, teriparatide and sclerostin inhibitors (romosozumab and blosozumab).
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: The Regulation of Bone Metabolism and Disorders by Wnt Signaling. (Pubmed Central) - Apr 14, 2020
In this review, the basics of Wnt signaling, its role in bone metabolism and its involvement in skeletal disorders have been covered. Furthermore, the clinical significance and future scopes of Wnt signaling in osteoporosis, osteoarthritis, rheumatoid arthritis and neoplasia are discussed.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB, zoledronic acid / Generic mfg.
Journal: Clinically Relevant Doses of Sclerostin-Antibody do not Induce Osteonecrosis of the Jaw (ONJ) in Rats with Experimental Periodontitis. (Pubmed Central) - Apr 10, 2020
Antiresorptive agents, such as bisphosphonates and denosumab, are frequently used for the management of osteoporosis...In clinical trials, a sclerostin antibody (romosozumab, Amgen Inc., UCB Brussels) increases bone formation and lowers the risk of osteoporotic fractures...Beginning 8 weeks post-ovariectomy, rats were treated for 22 weeks with weekly injections of vehicle (Veh), 200 μg/kg zoledronic acid (ZA), a potent bisphosphonate at 100-fold the osteoporosis dose, or 5 mg/kg sclerostin antibody (Scl-Ab) at the osteoporotic dose...However, these animals presented with no histologic signs of ONJ. In conclusion, sclerostin inhibition enhanced structural bone parameters, without inducing ONJ-like lesions, in ovariectomized rats with EP.
- |||||||||| lamivudine / Generic mfg.
Journal: Drug updates and approvals: 2019 in review. (Pubmed Central) - Mar 22, 2020
In 2019, the FDA approved several new drugs for use in primary care. This article highlights the following new drugs: risankizumab-rzaa (Skyrizi); halobetasol and tazarotene (Duobrii); dolutegravir and lamivudine (Dovato); romosozumab-aqqg (Evenity); brexanolone (Zulresso); solriamfetol (Sunosi); aclidinium and formoterol (Duaklir Pressair); and siponimod (Mayzent).
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
[VIRTUAL] EARLY CLINICAL EFFICACY OF ROMOSOZUMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS AND PRIMARY OSTEOPOROSIS (Poster Tour) - Mar 5, 2020 - Abstract #EULAR2020EULAR_1114;
The sequence of romosozumab to rebuild the skeletal foundation before transitioning to antiresorptive treatment with denosumab is a promising regimen for Japanese postmenopausal women with osteoporosis at high risk of fracture. Early clinical efficacy of ROM for RA-OP and P-OP was extremely effective and has the high potential to be an important option in the treatment of osteoporosis.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Cardiovascular Outcomes of Romosozumab and Protective Role of Alendronate. (Pubmed Central) - Mar 2, 2020
Based on the opposing roles of bisphosphonates and the Wnt pathway on endothelial dysfunction, lipid accumulation and calcification of the vessel walls, the combination of romosozumab and bisphosphonates could be a new therapeutic approach to reducing the risks of adverse cardiovascular events in romosozumab receivers. Visual Overview- An online visual overview is available for this article.
- |||||||||| 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) - Feb 12, 2020
P4, N=72, Not yet recruiting,
This network meta-analysis provides comparative effective estimates for the various available treatments to reduce the risk of fragility fractures in postmenopausal women. Trial completion date: Dec 2023 --> Apr 2024 | Initiation date: Apr 2020 --> Jul 2020 | Trial primary completion date: Apr 2023 --> Jul 2023
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB, zoledronic acid / Generic mfg., Asahi Kasei
Journal: Osteoporosis (Pubmed Central) - Jan 28, 2020
There is no benefit of vitamin D supplementation on musculoskeletal health in the general population, but vitamin D remains indicated in patients with vitamin D deficiency or receiving osteoporosis treatment. A sequential treatment with romosozumab during one year, a bone anabolic anti-sclerostin antibody, followed by two years of denosumab, decreases vertebral and non-vertebral fractures with rapid and substantial BMD gains after 3 years.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Sclerostin in chronic kidney disease-mineral bone disorder think first before you block it! (Pubmed Central) - Dec 29, 2019
Consequently, blocking sclerostin via human monoclonal antibodies (such as romosozumab) represents a promising perspective for the treatment of (postmenopausal) osteoporosis...The present review summarizes the potential effects of sclerostin blockade in CKD-MBD. We will address and summarize the urgent research targets that are being identified and that need to be addressed before a valid risk-benefit ratio can be established in the clinical setting of CKD.
- |||||||||| abaloparatide (BA058) / Radius, Evenity (romosozumab) / Astellas, Amgen, UCB
Retrospective data, Review, Journal: Comparative efficacy of bone anabolic therapies in women with postmenopausal osteoporosis: A systematic review and network meta-analysis of randomized controlled trials. (Pubmed Central) - Dec 23, 2019
We will address and summarize the urgent research targets that are being identified and that need to be addressed before a valid risk-benefit ratio can be established in the clinical setting of CKD. Abaloparatide, romosozumab, and teriparatide are the best treatments, respectively, to reduce vertebral/non-vertebral fractures, increase BMD, and increase bone formation.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment closed, Trial completion date, Head-to-Head: A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis (clinicaltrials.gov) - Dec 19, 2019
P3, N=283, Active, not recruiting,
Abaloparatide, romosozumab, and teriparatide are the best treatments, respectively, to reduce vertebral/non-vertebral fractures, increase BMD, and increase bone formation. Completed --> Active, not recruiting | Trial completion date: Jul 2019 --> Jan 2020
- |||||||||| Faculty (Room 11) - Dec 14, 2019 - Abstract #ENDO2020ENDO_738;
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.
- |||||||||| Faculty (Room 10) - Dec 14, 2019 - Abstract #ENDO2020ENDO_719;
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, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Balancing benefits and risks in the era of biologics. (Pubmed Central) - Nov 7, 2019
To date, several risk mitigation strategies have been identified and implemented. The objective of the present perspective review is to examine the risk mitigation strategies of biologic treatments, with special focus on anti-tumor necrosis factors and denosumab.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, P2 data, Journal: Effects of 24 months of treatment with romosozumab followed by 12 months of denosumab or placebo in postmenopausal women with low bone mineral density: A randomized, double-blind, phase 2, parallel group study. (Pubmed Central) - Oct 27, 2019
P2
Adverse events were balanced between treatment groups through month 36. These data suggest that treatment effects of romosozumab are reversible upon discontinuation and further augmented by denosumab.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Romosozumab: First Global Approval. (Pubmed Central) - Oct 8, 2019
On the basis of favourable results from several phase III trials in postmenopausal women with osteoporosis, and a single trial in men with osteoporosis, romosozumab is being considered for marketing approval in the US, EU and Canada, and was recently approved for marketing in Japan. This article summarizes the milestones in the development of romosozumab leading to this first approval for the treatment of osteoporosis in patients at high risk of fracture.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Extensive Modeling-Based Bone Formation After 2 Months of Romosozumab Treatment: Results from the FRAME Clinical Trial (B207-B208) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_2909;
P3
In FRAME, postmenopausal women aged ≥55 years with osteoporosis (BMD T-score ≤–2.5 and >–3.5 at the total hip or femoral neck) were randomized 1:1 to 210 mg Romo or Pbo SC QM for 12 months, followed by 60 mg denosumab SC Q6M for 12 months. These data show that stimulation of bone formation in the first 2 months of Romo treatment is predominately due to increased MBBF on the Ec and Cn surfaces.
- |||||||||| bortezomib / J&J, Generic Mfg., Evenity (romosozumab) / Astellas, Amgen, UCB, Kyprolis (carfilzomib) / Amgen, Ono Pharma
Review, Journal: Role of Osteocytes in Myeloma Bone Disease: Anti-sclerostin Antibody as New Therapeutic Strategy. (Pubmed Central) - Oct 2, 2019
Monoclonal antibody anti-sclerostin, Romosozumab, has been developed and tested in clinical trials in patients with osteoporosis...When compared to healthy controls, myeloma patients with bone disease have higher osteocyte cell death, but the treatment with proteasome inhibitor bortezomib has been shown to maintain osteocyte viability...Moreover, the combination of anti-sclerostin antibody and the osteoclast inhibitor zoledronic acid increased bone mass and fracture resistance synergistically...Nevertheless, the combination therapy of anti-sclerostin antibody and the proteasome inhibitor carfilzomib, displayed potent anti-myeloma activity as well as positive effects on bone disease in vivo. In conclusion, all these data suggest that osteocytes are involved in myeloma bone disease and may be considered a novel target for the use of antibody-mediated anti-sclerostin therapy also in multiple myeloma patients.
- |||||||||| abaloparatide (BA058) / Radius, Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Treatment of osteoporosis: whom, how and for how long? (Pubmed Central) - Sep 11, 2019
For patients with lower risk, a period off treatment might be considered after this initial course to minimize the risks associated with more prolonged treatment, but this only applies to bisphosphonates and not denosumab or teriparatide. This review discusses strategies for case finding of patients at risk, currently available treatment options, recent developments in pharmacological management and duration of treatment.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: The sequential therapy of romosozumab followed by denosumab for osteoporosis. (Pubmed Central) - Sep 8, 2019
In the pivotal Fracture study in postmenopausal women with osteroposis(FRAME)and the extension trial, 12 months of romosozumab led to persistent fracture, especially new vertebral fracture, reduction benefit and ongoing BMD(bone mineral density)gains when follow 24 months of denosumab. The sequence therapy of romosozumab followed by denosumab may be a promising regimen for the treatment of osteoporosis.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Sequential treatment of osteoporosis with anti-sclerostin. (Pubmed Central) - Sep 8, 2019
This overview summarizes the results of ARCH study demonstrating superior efficacy of romosozumab compared to alendronate and effect of sequential therapy with alendronate. Possible adverse effect of romosozumab on cardiovascular diseases will also be discussed.
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