- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Osteoporosis-Update 2021 (Pubmed Central) - Oct 20, 2021
The recent approval of the sclerostin-antibody romosozumab as a novel first in class anabolic drug is another milestone that enriches our therapeutic portfolio...Basically, osteoporosis is a chronic disease and has to be treated as such. If however for whatever reason treatment regimens using biologicals are being discontinued we have to be aware that such situations need to be stabilized using long-acting bisphosphonates to maintain the therapeutic success and avoid rapid bone loss and fracture risk.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Effects of sclerostin antibody on bone healing. (Pubmed Central) - Oct 12, 2021
On the other hand, two clinical reports have researched Scl-Ab in bone healing and failed to show positive effects in the femur and tibia. This review discusses why Scl-Ab appears to be effective in animal models of fracture healing and not in clinical cases.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Review, Journal: Romosozumab and cardiovascular safety in Japan. (Pubmed Central) - Oct 12, 2021
Further relevant investigations are essential to understand whether romosozumab is actually involved in the development of cardiovascular events or not. We need more robust evidence to establish an appropriate and reasonable guide to prescribe romosozumab in our clinical practice.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Review, Journal: Cardiovascular Safety and Sclerostin Inhibition - a mini-review. (Pubmed Central) - Oct 6, 2021
In conclusion, while there is no preclinical or genetic evidence of a harmful effect of sclerostin inhibition on cardiovascular safety, the evidence from the large clinical trials in postmenopausal women is conflicting. Romosozumab should therefore be used for the treatment of postmenopausal women with osteoporosis at high risk of fracture after careful consideration of the cardiovascular risk and the balance between benefits and risks.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment open: Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa (clinicaltrials.gov) - Sep 24, 2021
P3, N=75, Recruiting,
It is imperative for spine surgeons to understand the mechanisms of action of these drugs and their effects on biology of fusion. Not yet recruiting --> Recruiting
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal, HEOR: An Updated Systematic Review of Cost-Effectiveness Analyses of Drugs for Osteoporosis. (Pubmed Central) - Sep 19, 2021
In comparison with a previous review, recent economic evaluations of anti-osteoporosis drugs were conducted in more countries and included more active drugs and sequential therapy as interventions/comparators. The updated economic evidence could help decision makers prioritize health interventions and the unmet/unreported quality issues indicated by the osteoporosis-specific guideline could be useful in improving the transparency, quality, and comparability of future economic evaluations in osteoporosis.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Phase classification: Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa (clinicaltrials.gov) - Sep 16, 2021
P3, N=75, Not yet recruiting,
The updated economic evidence could help decision makers prioritize health interventions and the unmet/unreported quality issues indicated by the osteoporosis-specific guideline could be useful in improving the transparency, quality, and comparability of future economic evaluations in osteoporosis. Phase classification: P1 --> P3
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Diagnosis and Management of Osteoporosis During COVID-19: Systematic Review and Practical Guidance. (Pubmed Central) - Sep 16, 2021
We focus on the issues surrounding initiation and maintenance of treatment for patients on parenteral therapies such as zoledronate, denosumab, teriparatide, and romosozumab during the pandemic. The design of these innovative care pathways for the management of patients with osteoporosis may also provide a platform for future improvement to osteoporosis services when routine clinical care resumes.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal, HEOR: Denosumab, raloxifene, romosozumab and teriparatide to prevent osteoporotic fragility fractures: a systematic review and economic evaluation. (Pubmed Central) - Sep 15, 2021
The design of these innovative care pathways for the management of patients with osteoporosis may also provide a platform for future improvement to osteoporosis services when routine clinical care resumes. Non-bisphosphonates are effective in preventing fragility fractures, but the incremental cost-effectiveness ratios are generally greater than the commonly applied threshold of £20,000-30,000 per quality-adjusted life-year.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Which treatment to prevent an imminent fracture? (Pubmed Central) - Aug 14, 2021
Ibandronate is the only one without demonstrated efficacy against non-vertebral and hip fractures...Compared with risedronate, which significantly reduces the rate of hip fractures, zoledronate, denosumab, teriparatide, abaloparatide and romosozumab are more efficient for vertebral fractures but not for non-vertebral or hip fractures reduction...In patients at high risk of imminent fracture, starting therapy with potent antiresorptive agents or with an anabolic agent seems most appropriate to promptly reduce the fracture risk. Available NMA/MA suggest that, compared to zoledronate and denosumab, anabolic agents have a higher efficacy for vertebral fractures but head-to-head studies are lacking.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Romosozumab: A first-in-class sclerostin inhibitor for osteoporosis. (Pubmed Central) - Aug 13, 2021
Available NMA/MA suggest that, compared to zoledronate and denosumab, anabolic agents have a higher efficacy for vertebral fractures but head-to-head studies are lacking. Romosozumab is a novel, 12-month treatment option for postmenopausal women at high risk for osteoporotic fracture that both increases bone formation and decreases bone resorption.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Recent Progresses in the Treatment of Osteoporosis. (Pubmed Central) - Aug 10, 2021
However, they do have limitations and adverse effects, which, to some extent, helped the development of anabolic drugs such as teriparatide and romosozumab...Our review focused on recent progress with regards to the drug development by modification of Wnt pathway, while other pathways/molecules were also discussed briefly. In addition, new observations made in recent years in bone biology were summarized and discussed for the treatment of OP.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: The Treatment Gap in Osteoporosis. (Pubmed Central) - Jul 20, 2021
Recently, romosozumab has been added as well...Knowledge of these could be very helpful in improving compliance and hopefully reducing the gap. In this paper, we summarize recent evidence regarding the efficacy of the various treatment options, potential side effects, and the overall benefit of treatment.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal, Combination therapy: Bone healing of distal radius nonunion treated with bridge plating with bone graft substitutes in combination with systemic romosozumab administration: A case report. (Pubmed Central) - Jul 17, 2021
During romosozumab treatment, bone formation marker levels increased rapidly and finally returned to baseline, and bone resorption marker levels remained low. In conclusion, combination of systemic romosozumab administration and grafting β-tricalcium phosphate with bridge plating provides an effective treatment option for difficult cases of comminuted distal radius nonunion with risk factors such as smoking, diabetes, and fragility.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Pharmacological agents and natural compounds: available treatments for osteoporosis. (Pubmed Central) - Jul 16, 2021
Anabolic drugs such as teriparatide, strontium ranelate, romosozumab have recently become available based on advanced clinical trials...In addition, possible mechanisms of action of all aforementioned treatments associated with bone remodelling, osteoclastogenesis, osteoblastogenesis, bone cell activity, death, and oxidative stress are presented. Nevertheless, more high-quality clinical studies with natural compounds are needed to provide greater evidence of the beneficial and safer antiosteoporotic application for the candidate.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Skeletal responses to romosozumab after 12 months of denosumab. (Pubmed Central) - Jul 15, 2021
P2
© 2021 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB, odanacatib (MK-0822) / Merck (MSD)
Clinical, Review, Journal: Cardiovascular Safety of Antifracture Medications in Patients With Osteoporosis: A Narrative Review of Evidence From Randomized Studies. (Pubmed Central) - Jul 15, 2021
JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research Recently, the discontinuation of odanacatib (anti-cathepsin K monoclonal antibody) over stroke concerns and the imbalance in ischemic events in romosozumab-treated (anti-sclerostin monoclonal antibody) women compared to bisphosphonate-treated women, has provided further justification to better characterize potential CV benefits and harms of osteoporosis medications.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Review, Journal: Assessment of Cardiovascular Safety of Anti-Osteoporosis Drugs. (Pubmed Central) - Jul 14, 2021
Denosumab does not appear to be associated with cardiovascular disease and, although parathyroid hormone analogues are associated with palpitations and dizziness, no association with a defined cardiovascular pathology has been demonstrated. Finally, romosozumab has been shown to have a possible cardiovascular signal, and therefore post-market surveillance of this therapy will be vital.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Osteocyte Mechanosensing following short-term and long-term treatment with Sclerostin antibody. (Pubmed Central) - Jul 11, 2021
Sclerostin antibody romosozumab (EVENITY™, romosozumab-aqqg) has a dual mechanism of action on bone, increasing bone formation and decreasing bone resorption, leading to increases in bone mass and strength, and a decreased risk of fracture, and has been approved for osteoporosis treatment in patients with high risk of fragility fractures...Furthermore, under matched strain environments, we found that short-term sclerostin antibody treatment results in a reduction of both the number of responsive cells and the speed of their responses, which we attribute largely to the probability that the observed cells in the short-term group are relatively immature osteocytes embedded during initial pharmacologic anabolism. Within this study, we demonstrate that osteocytes embedded following long-term sclerostin antibody treatment exhibit localized Ca signaling akin to those of mature osteocytes from the vehicle group, and thus, systemic attenuation of responses such as circulating P1NP and bone formation rates likely occur as a result of processes downstream of osteocyte Ca signaling.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Romosozumab for osteoporosis. (Pubmed Central) - Jul 3, 2021
Within this study, we demonstrate that osteocytes embedded following long-term sclerostin antibody treatment exhibit localized Ca signaling akin to those of mature osteocytes from the vehicle group, and thus, systemic attenuation of responses such as circulating P1NP and bone formation rates likely occur as a result of processes downstream of osteocyte Ca signaling. No abstract available
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Vaccination for Covid-19 and relationship to osteoporosis care: Current evidence and suggested approaches. (Pubmed Central) - Jul 3, 2021
Depending on the specific drug profile within an anti-osteoporosis medication category, minor adjustments to the timing of drug administration may be considered with respect to the patient's COVID-19 vaccination schedule. Herein we provide practical recommendations for the care of patients requiring treatment for osteoporosis in the setting of COVID-19 vaccination.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Retrospective data, Review, Journal: Clinical effectiveness of denosumab, raloxifene, romosozumab, and teriparatide for the prevention of osteoporotic fragility fractures: A systematic review and network meta-analysis. (Pubmed Central) - Jun 22, 2021
The four non-bisphosphonate interventions studied were all statistically significantly clinically effective for reducing vertebral fractures when compared to placebo, and were beneficial for change in FN BMD compared to placebo. All reduced hip fractures, and this was statistically significant for TPTD, ROMO followed by ALN, and DEN.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Review, Journal: Denosumab or romosozumab therapy and risk of cardiovascular events in patients with primary osteoporosis: Systematic review and meta- analysis. (Pubmed Central) - Jun 22, 2021
All reduced hip fractures, and this was statistically significant for TPTD, ROMO followed by ALN, and DEN. Denosumab therapy was not associated with any risk of composite and specific cardiovascular outcomes among patients with primary osteoporosis than active comparators or placebo, while romosozumab therapy might increase the risk of 4P MACE.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, PK/PD data, Journal: Assessment of romosozumab efficacy in the treatment of postmenopausal osteoporosis: results from a mechanistic PK-PD mechanostat model of bone remodeling. (Pubmed Central) - Jun 22, 2021
For instance, at the femoral neck, our model predicts a BMD increase of 3.85% after 12 months of 210 mg injections, which is consistent with literature observations. Finally, our simulations indicate rapid bone loss after treatment discontinuation, indicating that some additional interventions such as use of bisphosphonates are required to maintain bone.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Treatment of postmenopausal osteoporosis with bone-forming and antiresorptive treatments: Combined and sequential approaches. (Pubmed Central) - Jun 22, 2021
The dual-action treatment; romosozumab leads to more pronounced increases in BMD than other treatment modalities and reduces the risk of vertebral and clinical fractures by 73% and 36% compared to placebo after 12 months and the sequential treatment regime; romosozumab for 12 months followed by alendronate reduced the risk of vertebral, non-vertebral and hip fractures by 48%, 20% and 38%, respectively compared to alendronate after 2-3 years...Studies have shown further improvements in BMD when transitioning from oral bisphosphonates to zoledronic acid or denosumab...This will often include sequential therapy which in severe cases preferably should start with bone-forming followed by antiresorptive treatment. The severity of osteoporosis, reaching a treatment goal, and responding to treatment failure are important factors determining the treatment sequence in the individual patient.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Effects of prior osteoporosis treatment on early treatment response of romosozumab in patients with postmenopausal osteoporosis. (Pubmed Central) - Jun 22, 2021
Early effects of ROMO on the increase in LS BMD are significantly affected by the difference of prior treatment and are predicted by the early change in bone turnover markers. Mini Abstract Early effects of ROMO on the increase in LS BMD at six months is significantly affected by the difference of prior treatment and also predicted by the early change of bone turnover markers in patients with postmenopausal osteoporosis.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Review, Journal: Anabolic treatments for osteoporosis in postmenopausal women. (Pubmed Central) - Jun 22, 2021
Data from head-to-head studies comparing anabolic and antiresorptive treatments are reviewed. At present, anabolic treatments are generally reserved for use in patients with severe osteoporosis at very high fracture risk; the factors limiting their more widespread use are discussed together with how this may change in the future.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Review, Journal: Romosozumab (sclerostin monoclonal antibody) for the treatment of osteoporosis in postmenopausal women: A review. (Pubmed Central) - Jun 4, 2021
Additionally, clinical trials demonstrated the risk for serious cardiovascular events among patients that received ROMO, and these severe adverse reactions deserve further investigation. Although ROMO presents as a potentially exciting therapeutic with serious clinical implications, the authors recommend further analysis using real-world evidence (RWE) studies to fully elucidate the cardiovascular event risk associated with ROMO administration.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Sclerostin: from bench to bedside. (Pubmed Central) - May 15, 2021
Romosozumab, a specific anti-sclerostin antibody, inhibits sclerostin-LRP5/6 interactions and indirectly activates canonical Wnt signaling pathways and bone formation. This review focuses on the mechanism of action of sclerostin and summarizes clinical studies that demonstrated the efficacy of romosozumab to increase bone mineral density and reduce osteoporotic fractures, as well as its cardiovascular safety.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Molecular Targeted Therapy for the Bone Loss Secondary to Pyogenic Spondylodiscitis Using Medications for Osteoporosis: A Literature Review. (Pubmed Central) - May 15, 2021
Bone loss due to infections involves the suppression of osteoblastogenesis by osteoblast apoptosis, which is induced by the nuclear factor-κB and mitogen-activated protein kinase pathways, and osteoclastogenesis with the receptor activator of the nuclear factor-κB ligand-receptor combination and subsequent activation of the nuclear factor of activated T cells cytoplasmic 1 and c-Fos. In this study, we review and discuss the molecular mechanisms of bone loss secondary to infection and analyze the efficacy of the medications for osteoporosis, focusing on romosozumab, teriparatide, denosumab, and bisphosphonates, in treating this pathological condition.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal, Adverse events, Real-world evidence: Real-world effects and adverse events of romosozumab in Japanese osteoporotic patients: A prospective cohort study. (Pubmed Central) - May 14, 2021
Sixty-four (27.8%) of 230 patients experienced an adverse event, and 7 (3.0%) new fractures were recorded. In sum, romosozumab treatment for 12 months significantly improved lumbar spine, total hip, and femoral neck BMD according to real-world data.
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