- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Osteoporosis in hemophilia: what is its importance in clinical practice? (Pubmed Central) - Sep 14, 2022
They include the use of antiresorptives (estrogens, selective estrogen receptor modulators, bisphosphonates, denosumab) and anabolic agents (teriparatide, abaloparatide, romosozumab). Further studies on the management of osteoporosis in patients with hemophilia are required.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: The role of osteoanabolic agents in the management of patients with osteoporosis. (Pubmed Central) - Aug 26, 2022
At the end of a 12-to-24-month course of osteoanabolic therapy, transitioning to a potent anti-remodeling agent maintains and enhances the treatment benefit. This review describes the clinical applications of osteoanabolic therapy for osteoporosis.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Role of Wnt signaling and sclerostin in bone and as therapeutic targets in skeletal disorders. (Pubmed Central) - Aug 22, 2022
Further studies with longer duration and follow-up are needed to confirm the results of this meta-analysis. Preclinical studies demonstrated safety and efficacy of therapy with anti-sclerostin monoclonal antibodies in the preservation/restoration of bone mass and prevention of fragility fractures in low-bone-mass clinical phenotypes, other than osteoporosis, to be validated by clinical studies for their approved translation into prevalent clinical practice.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Preclinical, Journal: The effects of romosozumab combined with active vitamin D on fracture healing in ovariectomized rats. (Pubmed Central) - Aug 22, 2022
Preclinical studies demonstrated safety and efficacy of therapy with anti-sclerostin monoclonal antibodies in the preservation/restoration of bone mass and prevention of fragility fractures in low-bone-mass clinical phenotypes, other than osteoporosis, to be validated by clinical studies for their approved translation into prevalent clinical practice. Although romosozumab and active vitamin D combination therapy increased trabecular bone volume, there was no evidence on its ability to accelerate fracture healing.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Extensive Expertise in Endocrinology: Osteoporosis Management. (Pubmed Central) - Aug 21, 2022
Romosozumab is unique in that it has both activities...Denosumab is a further potent anti-resorptive agent given as 6-monthly s.c. injections...25-hydroxyvitamin D levels should be maintained above 30 nmol/L, using supplements if sunlight exposure is limited. Calcium intake has little effect on bone density and fracture risk but should be maintained above 500 mg/day using dietary sources.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Interest of Bone Histomorphometry in Bone Pathophysiology Investigation: Foundation, Present, and Future. (Pubmed Central) - Aug 17, 2022
Bone histomorphometric studies allow us to understand the mechanism of coupling between formation and resorption and to evaluate the respective role of bone modeling and remodeling. The adaptation of new image analysis techniques will help bone biopsy analysis in the future.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment closed, Enrollment change: A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis (clinicaltrials.gov) - Aug 12, 2022
P3, N=564, Active, not recruiting,
Sclerostin loop3-specific aptamer Apc001PE promoted bone formation without increasing cardiovascular risk in OI mice. Recruiting --> Active, not recruiting | N=300 --> 564
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Romosozumab and Renal Function. (Pubmed Central) - Aug 12, 2022
No abstract available No abstract available
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Marine fungal products for drug leads to treat osteoporosis | Poster Board #2866 (Hall F2 (McCormick Place Convention Center)) - Aug 9, 2022 - Abstract #ACSFall2022ACS_Fall_12919;
Although a drug with dual activities (romosozumab) was approved by US FDA in 2019, there is a safety concern of cardiovascular events with this drug...Taken together, austalide K may lead to new therapeutic candidates for osteoporosis. In our presentation, our study on its pharmacokinetics and drug metabolism along with bioactivities will be discussed.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Pros and Cons of Skeletal Medications in the COVID-19 Era. (Pubmed Central) - Jul 27, 2022
In contrast, interruption of denosumab treatment is strongly discouraged because of rapid loss of bone mass and an associated increased risk for rebound vertebral fractures...The impact of the COVID-19 pandemic on long-term bone health remains unknown but focused interventions to ensure osteoporosis treatment initiation/maintenance should be implemented. Future studies are needed to determine whether osteoporosis medications have an impact on SARS-CoV-2 pathophysiology and COVID-19 clinical outcomes.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Romosozumab-aqqg in the Treatment of Osteoporosis in a Patient with Hypophosphatasia (ENDOExpo, Pod 2) - Jul 16, 2022 - Abstract #ENDO2022ENDO_2787;
Learning Objective 1: Understand the limitations of current pharmacologic therapy for the treatment of osteoporosis in patients with hypophosphatasia and identify the improvement in bone density using romosozumab-aqqg in one such patient. Science Topic(s) for Bone and Mineral Metabolism: Osteoporosis
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Efficacy of Romosozumab for Osteoporosis in a Patient with Hajdu-Cheney Syndrome: A Case Report () - Jul 16, 2022 - Abstract #ENDO2022ENDO_1476;
This is the first treatment report of romosozumab for an osteoporotic HCS patient in Korea. One year of romosozumab treatment provided substantial gains in BMD and prevented progressive acroosteolysis, which represents a promising treatment option for the rare disease of HCS.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Trial completion date, Trial primary completion date: Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta (clinicaltrials.gov) - Jul 15, 2022
P1, N=25, Recruiting,
One year of romosozumab treatment provided substantial gains in BMD and prevented progressive acroosteolysis, which represents a promising treatment option for the rare disease of HCS. Trial completion date: Jul 2023 --> Feb 2023 | Trial primary completion date: Jul 2023 --> Feb 2023
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Role of Sclerostin in Cardiovascular Disease. (Pubmed Central) - Jun 25, 2022
Human genetic studies reported variants predisposing to low arterial sclerostin expression were associated with a high risk of cardiovascular events. Overall, past research suggests a cardiovascular protective role of sclerostin but findings have been inconsistent, possibly due to variations in study design, the unique populations and models studied, and the heterogeneous methods used.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Drug discovery of sclerostin inhibitors. (Pubmed Central) - Jun 4, 2022
Furthermore, romosozumab could only be administered by injection, which may cause compliance issues for patients who prefer oral therapy. Considering these above safety and compliance concerns, we therefore present relevant discussion and offer perspectives on the development of next-generation sclerostin inhibitors by following several ways, such as concomitant medication, artificial intelligence-based strategy, druggable modification, and bispecific inhibitors strategy.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Preclinical, Journal: Anti-sclerostin antibodies and abaloparatide have additive effects when used as a countermeasure against disuse osteopenia in female rats. (Pubmed Central) - May 26, 2022
The aim of present study was to compare the efficacy of romosozumab (Scl-Ab) and abaloparatide (ABL), alone or in combination, to prevent botulinum toxin (BTX) induced bone loss in a rat model...The potent and additive osteoanabolic effect of Scl-Ab and ABL, when given in combination, is highly intriguing and underlines that an osteoanabolic bone gain can be maximized by utilizing two pharmaceuticals targeting different cellular signaling pathways. From a clinical perspective, a combination treatment may be warranted in patients where the osteoanabolic effect of either monotherapy is not sufficient, or if a dose-reduction is required due to adverse effects.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Romosozumab and antiresorptive treatment: the importance of treatment sequence. (Pubmed Central) - May 19, 2022
In this study, larger mean BMD increases and greater BMD responder rates were achieved when romosozumab was used before, versus after, an antiresorptive agent. Since BMD on treatment is a strong surrogate for bone strength and fracture risk, this analysis supports the thesis that initial treatment with romosozumab followed by an antiresorptive will result in greater efficacy versus the reverse sequence.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Challenges in Conducting Pragmatic Care Strategy Studies in Osteoporosis: Patient Perceptions (Poster View 8) - May 6, 2022 - Abstract #EULAR2022EULAR_2544;
We identified several potential modifiable barriers to clinical trial recruitment. Patient perceptions collected from this pilot will inform enrollment strategies, which can be incorporated early when planning direct-to-patient pragmatic osteoporosis studies to achieve recruitment goals.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Review, Journal: The effect of osteoporosis treatment on bone mass. (Pubmed Central) - May 6, 2022
After discontinuation of these antibodies, bone mineral density quickly returns to baseline and in the case of denosumab, discontinuation can not only induce rebound bone loss, but also the occurrence of vertebral fractures. Therefore, sequential antiresorptive therapy to maintain bone mass gains and anti-fracture efficacy is of utmost importance and will also be discussed in this review.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal, HEOR: Cost-effectiveness of romosozumab for the treatment of postmenopausal women at very high risk of fracture in Canada. (Pubmed Central) - May 3, 2022
Romosozumab/alendronate was associated with reduced costs and greater benefit relative to other comparators. Probabilistic, deterministic, and scenario analyses indicate that romosozumab/alendronate represents the best value for money; the uncertainty analyses are robust, and therefore romosozumab should be considered for reimbursement by public drug plans in Canada .
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment change: Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta (clinicaltrials.gov) - Apr 25, 2022
P1, N=25, Recruiting,
Probabilistic, deterministic, and scenario analyses indicate that romosozumab/alendronate represents the best value for money; the uncertainty analyses are robust, and therefore romosozumab should be considered for reimbursement by public drug plans in Canada . N=16 --> 25
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Osteoanabolic therapy for osteoporosis in women. (Pubmed Central) - Apr 22, 2022
The osteoanabolic drugs include teriparatide, which has been available for several years, and abaloparatide and romosozumab, novel osteoanabolic drugs that have become available more recently...Primarily because of the high cost of the drugs, these therapies are initiated by specialists rather than primary-care physicians in most countries. This review will present the evidence for efficacy and safety of these drugs so that clinicians may discern their appropriate use when caring for postmenopausal women with osteoporosis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Medical treatment of osteoporosis. (Pubmed Central) - Apr 22, 2022
In high-risk patients, anabolic agents may be considered as an initial therapeutic option. The combination of antiresorptive and anabolic agents may be useful to increase BMD compared with monotherapy, but more information is warranted to determine the effects on fracture risk.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
WNT Modulating Gene Silencers as Novel Gene Therapy for Osteoporosis and Critical Sized Bone Defect (Poster Board Number: Tu-104; Hall D) - Apr 20, 2022 - Abstract #ASGCT2022ASGCT_1209;
Romosozumab, a humanized monoclonal antibody, significantly increased bone mineral density with increase in levels of bone-formation markers over the first 6 to 9 months of treatment in postmenopausal women...Finally, transplantation of a synthetic bone or decellularized isograft expressing a single silencer targeting SHN3 or SOST, by directly attaching bone-specific rAAV to hydroxyapatite, was effective to promote healing of critical-sized bone defect. Collectively, our proof-of-concept studies demonstrate the potential of bone-specific WNT-modulating gene silencers to treat skeletal disorders associated with low bone mass and impaired fracture repair.
|
