- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Severe Hypocalcemia With Denosumab Among Older Female Dialysis-Dependent Patients. (Pubmed Central) - Jan 19, 2024
Denosumab was associated with a markedly higher incidence of severe and very severe hypocalcemia in female dialysis-dependent patients aged 65 years or older compared with oral bisphosphonates. Given the complexity of diagnosing the underlying bone pathophysiology in dialysis-dependent patients, the high risk posed by denosumab in this population, and the complex strategies required to monitor and treat severe hypocalcemia, denosumab should be administered after careful patient selection and with plans for frequent monitoring.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Enrollment closed: MITO: Muscle Impact of Treating Osteoporosis (clinicaltrials.gov) - Jan 18, 2024
P4, N=20, Active, not recruiting,
These findings indicate that the effects of osteoporotic treatment of switch therapy from romosozumab to denosumab were likely to affect prior treatment of osteoporosis. Recruiting --> Active, not recruiting
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, Adverse events: Pharmacovigilance. Withdrawal and rebound effects: not just with psychotropic drugs (Pubmed Central) - Jan 17, 2024
This type of unintended effect, often underestimated, generally results from a drug-induced homeostatic imbalance that persists after the drug has been discontinued. Taking this risk into account right from the initial prescription should make it possible to prevent such complications, by encouraging intermittent use of the drug, or by applying a very gradual reduction in dosage when a regular treatment is stopped.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Journal, IO biomarker: Association of denosumab with serum cytokines, chemokines, and bone-related factors in patients with rheumatoid arthritis: A post hoc analysis of a multicentre, open-label, randomised, parallel-group study. (Pubmed Central) - Jan 16, 2024
However, denosumab treatment did not affect coronary artery calcifications in these patients. Denosumab may inhibit bone destruction by suppressing bone-related factors/chemokines.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Oldest reported patients with RAB18 deficiency due to RAB3GAP1 gene mutations (MTCC - Exhibit Halls DE) - Jan 10, 2024 - Abstract #ACMG2024ACMG_1101;
Accurate diagnosis has been shown to reduce hospitalizations and healthcare costs even if there's no definitive or curative treatment. The probands' newly found seizures prompted treatment with valproate which improved behavior and caused less side effects than potent antipsychotics.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Fat Body Mass and Vertebral Fracture Progression in Women With Breast Cancer. (Pubmed Central) - Jan 10, 2024
The findings of this study suggest that baseline FBM is an independent factor for VF progression in patients with EBC treated with adjuvant AIs and denosumab. This observation is new and indicates that diet and exercise may synergize with denosumab in the management of bone health in this patient setting.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Medication-related osteonecrosis of the lower jaw without osteolysis on computed tomography images. (Pubmed Central) - Jan 9, 2024
This observation is new and indicates that diet and exercise may synergize with denosumab in the management of bone health in this patient setting. Surgical treatment yielded good treatment outcomes in most patients with mandibular MRONJ; however, the cure rate was lower in patients with malignancy who showed no osteolysis on CT images.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Enrollment closed, Trial completion date, Trial primary completion date: Denosumab (DMAB) Discontinuation And Switching In Glucocorticoid-Induced Osteoporosis (GIOP): A Pilot Study (clinicaltrials.gov) - Jan 9, 2024
P4, N=45, Active, not recruiting,
Analysis of the effect of OP therapies on hip geometry is useful in understanding the mechanisms of their anti-fracture effect and may provide additional information on their efficacy. Recruiting --> Active, not recruiting | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Jan 2024 --> Dec 2024
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Denosumab use reduces risk of rheumatoid arthritis in patients with osteoporosis. (Pubmed Central) - Jan 5, 2024
Denosumab use reduces the risk of RA in patients with osteoporosis. Receptor activator of nuclear factor kappa B ligand (RANKL) mediated osteoclast joint damage may be involved in the pathogenesis of RA during the preclinical stage.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Denosumab versus pamidronate in the treatment of osteolytic bone metastases secondary to breast cancer: a multi-institutional analysis. (Pubmed Central) - Jan 4, 2024
There was no statistical difference for an increased risk in pathological fractures (2.7% vs. 2.8%, P?=?0.88), spinal cord compression (2.6% vs. 2.7%, P?=?0.88), or 5-year survival rate (45.5% vs. 52.4%, P?=?0.78) for the denosumab cohort versus the pamidronate cohort. Since neither therapy showed an increased risk in the adverse effects measured in this study, factors such as patient preference, financial costs, and additional side effects of each medication should be taken into consideration when choosing a therapy for bone metastases in patients with breast cancer.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Journal: Australian clinicians' perceptions of patients with very high risk of fracture. (Pubmed Central) - Jan 2, 2024
Australian clinicians' perceptions of patients with a VHR of fracture and the use of anabolic agents appear to be heavily influenced by local reimbursement criteria. The mismatch between patients deemed eligible for reimbursed anabolic therapy and those prescribed an anabolic agent suggests treatment inertia.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Diagnosis and Management of Osteoporosis: A Comprehensive Review of Guidelines. (Pubmed Central) - Dec 26, 2023
All guidelines reviewed recognize the efficacy of the pharmacologic agents (ie, bisphosphonates, denosumab, hormone therapy, and parathyroid hormone analogs)...Osteoporosis is a distressing condition for women, mainly those of postmenopausal age. Thus, it seems of paramount importance to develop consistent international practice protocols for more cost-effective diagnostic and management techniques, in order to improve women's quality of life.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal, Real-world evidence, Real-world: Methodological guidance for the use of real-world data to measure exposure and utilization patterns of osteoporosis medications. (Pubmed Central) - Dec 25, 2023
Finally, we present considerations for the measurement of osteoporosis medication exposure, adherence, switching, long-term exposures, and drug holidays using RWD. Ultimately, a thorough understanding of the differences in RWD sources and the pharmacology of osteoporosis medications is essential to obtain valid estimates of the relationship between osteoporosis medications and outcomes, such as fractures, but also to improve the critical appraisal of published studies.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Preclinical, Journal: Anti-Siglec-15 Antibody Prevents Marked Bone Loss after Acute Spinal Cord Injury-Induced Immobilization in Rats. (Pubmed Central) - Dec 22, 2023
Rapid and extensive sublesional bone loss after spinal cord injury (SCI) is a difficult medical problem that has been refractory to available interventions except the antiresorptive agent denosumab (DMAB)...JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Fibrous dysplasia in children and its management. (Pubmed Central) - Dec 22, 2023
Management of children with FD has unique challenges related to skeletal growth and age-related lesion progression. Inclusion of children in clinical research is critical to develop effective treatment strategies to treat FD lesions and prevent their development.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Review, Journal: The Sequential Therapy in Osteoporosis. (Pubmed Central) - Dec 18, 2023
Despite the absence of fracture data substantiating the implementation of integrated anabolic/antiresorptive pharmacotherapy, the incorporation of denosumab and teriparatide presents a potential avenue worthy of consideration for individuals at a heightened vulnerability to fragility fractures. A judiciously implemented sequential treatment strategy in osteoporosis offers a flexible and tailored approach to address diverse clinical scenarios, optimizing fracture prevention and patient outcomes.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical guideline, Review, Journal: A Review of Various Clinical Practice Guidelines on Osteoporosis in the Last 5 Years. (Pubmed Central) - Dec 18, 2023
The key agents recommended include Bisphosphonates, Teriparatide, Denosumab, SERMs, Hormone Replacement Therapy, and other agents including any drug holidays and duration of therapy. This review identified some key recommendations from CPGs from multiple nations in each of the above given aspects of osteoporosis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, Combination therapy: Combination Therapy of Denosumab and Teriparatide in Osteoporosis. (Pubmed Central) - Dec 18, 2023
The categories of drugs that are currently being used for osteoporosis are antiresorptives such as oral and intravenous bisphosphonates, denosumab, and anabolics like teriparatide. This article will focus on the combination therapy of denosumab and teriparatide and will discuss how this combination is better than other class of drugs when given alone or in combination in osteoporosis patients especially those who are at high risk of fragility fractures.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Glucocorticoid-Induced Osteoporosis (GIOP). (Pubmed Central) - Dec 18, 2023
Institution of proper therapeutic management as per WHO risk stratification with anabolic and/or resorptive drugs like bisphosphonates, teriparatide or denosumab is necessary to prevent the eventuality of fragility fractures. Even otherwise, knowledge of glucocorticoid, its metabolism, various dose schedules, adverse effects are areas worth discussing.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Biologic Antiresorptive: Denosumab. (Pubmed Central) - Dec 18, 2023
Therefore, modification to another anti-osteoporosis drug therapy after denosumab discontinuation is required to maintain bone health. Denosumab is a promising biological antiresorptive therapy for osteoporosis that offers high efficacy and safety, but also poses challenges for long-term management.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Micropetrosis: Osteocyte Lacunar Mineralization in Aging and Disease. (Pubmed Central) - Dec 18, 2023
Denosumab and bisphosphonates seem to affect lacunar mineralization differently, where specifically bisphosphonates have been shown to prolong osteocyte viability and reduce micropetrosis. Despite continuous proceedings in the field of osteocyte-lacunar-network characteristics, more studies are necessary to further clarify the mechanisms of lacunar mineralization, the inter-site variability of micropetrosis accumulation, the relevance of micropetrosis in various diseases and conditions, and whether micropetrosis could be an indicator of bone fragility or a target for treatment.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Avastin (bevacizumab) / Roche
Preclinical, Journal: Influence of antiresorptive/antiangiogenic therapy on changes in periodontal and oral tissue structures: a histomorphometrical analysis in rats. (Pubmed Central) - Dec 17, 2023
Despite continuous proceedings in the field of osteocyte-lacunar-network characteristics, more studies are necessary to further clarify the mechanisms of lacunar mineralization, the inter-site variability of micropetrosis accumulation, the relevance of micropetrosis in various diseases and conditions, and whether micropetrosis could be an indicator of bone fragility or a target for treatment. Administration of antiresorptive and antiangiogenic medications may be capable of inducing inflammatory reactions in periodontal tissues.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Journal, Real-world evidence, Real-world: Effectiveness of romosozumab in patients with osteoporosis at high fracture risk: a Japanese real-world study. (Pubmed Central) - Dec 12, 2023
Administration of antiresorptive and antiangiogenic medications may be capable of inducing inflammatory reactions in periodontal tissues. This large-scale, multicenter chart review provides clinically relevant insights into the profiles of patients initiating romosozumab, effectiveness of real-world romosozumab use, and sequential therapy in Japanese patients at high risk of fracture.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Enrollment open, Trial completion date, Trial primary completion date: Efficacy and Safety of Actonel (clinicaltrials.gov) - Dec 11, 2023
P4, N=155, Recruiting,
This large-scale, multicenter chart review provides clinically relevant insights into the profiles of patients initiating romosozumab, effectiveness of real-world romosozumab use, and sequential therapy in Japanese patients at high risk of fracture. Not yet recruiting --> Recruiting | Trial completion date: Oct 2024 --> Feb 2025 | Trial primary completion date: Oct 2024 --> Feb 2025
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Treatment for Gorham-Stout syndrome with a combination of teriparatide and denosumab. (Pubmed Central) - Dec 7, 2023
After treatment with bisphosphonates, this patient still had persistent resorption of the mandible, but switching to a teriparatide and denosumab combination yielded substantial improvement. This study is the first report to show that teriparatide combined with denosumab can be used to treat Gorham-Stout syndrome.
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