- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Role of the bone microenvironment in bone metastasis of malignant tumors - therapeutic implications. (Pubmed Central) - Jul 3, 2021
Here, we review the normal bone microenvironment, bone microenvironment-related factors that promote bone metastasis, as well as mechanisms underlying bone metastasis. In addition, we elude on directions for clinical bone metastasis management, focusing on potential therapeutic approaches to target bone microenvironment-related factors, including bisphosphonate, denosumab, CXCR4/CXCL12 antagonists and cathepsin K inhibitors.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Review, Journal, BRCA Biomarker: Non-surgical prevention strategies in women with hereditary breast and ovarian cancer syndromes. (Pubmed Central) - Jul 3, 2021
Summary and outlook Denosumab is a well-tolerated osteoprotective drug, which has been demonstrated to have a potential preventive effect particularly in BRCA1-deficient models in vitro. The prospectively randomized double-blind BRCA-P trial is currently investigating the preventative effect of denosumab in healthy BRCA1 germ line mutation carriers.
- |||||||||| 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
Retrospective data, Review, Journal: Lack of evidence in reducing risk of MRONJ after teeth extractions with systemic antibiotics. (Pubmed Central) - Jul 2, 2021
Of 1,512 results, 17 studies were included, focusing on antibiotics for extraction in patients under intravenous bisphosphonates (8 studies), oral bisphosphonates (2 studies), oral and intravenous bisphosphonates (6 studies), and denosumab (1 study), of which 12 performed dental extraction with surgical flap...First-line treatment was 2-3 grams of oral amoxicillin in 76.4% of studies; 300-600 mg of clindamycin was the alternative treatment in 23.5% of studies...QUIPS tool revealed moderate-high risk of bias. With empirical data from bias-carrying, heterogeneous observational studies, the validity of antibiotics is yet to be established.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Modeling-Based Bone Formation in the Human Femoral Neck in Subjects Treated With Denosumab. (Pubmed Central) - Jul 1, 2021
In the periosteal envelope, MBBF and RBBF rates were similar between subjects and controls. These results demonstrate the occurrence of MBBF in the human FN and suggest that denosumab preserves MBBF while inhibiting remodeling, which may contribute to the observed continued gains in BMD over time after remodeling is maximally inhibited.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Opdivo (nivolumab) / Ono Pharma, BMS, Nexavar (sorafenib) / Bayer, Amgen
Journal, Combination therapy: 223-Radium for metastatic osteosarcoma: combination therapy with other agents and external beam radiotherapy. (Pubmed Central) - Jul 1, 2021
Radiation therapy, including stereotactic body radiotherapy (SBRT), was also given to 11 patients concurrently with 223-radium (n=2), after 223-radium completion (n=3), or both concurrently and then sequentially for other sites (n=6). After 223-radium infusions, patients without RT had a median overall survival of 4.3 months compared with those with SBRT and/or RT, who had a median overall survival of 13.5 months.Conclusion Although only 1/15 of patients with osteoblastic osteosarcoma still remain alive after 223-radium, overall survival.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Radiological findings of denosumab treatment for giant cell tumours of bone. (Pubmed Central) - Jun 26, 2021
Reduction in F-FDG-PET avidity represents an early sensitive sign of response to denosumab treatment. Regardless of imaging modality, close follow-up in a specialist centre and careful evaluation of nonresponders is necessary as local recurrence after cessation of denosumab treatment and malignant transformation of GCTB have been described.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: A case of denosumab-associated membranous nephropathy in a patient with rheumatoid arthritis. (Pubmed Central) - Jun 22, 2021
Based on the renal biopsy results and clinical course (development of marked proteinuria in the presence of denosumab with subsequent amelioration in the absence of the drug), we diagnosed the patient with secondary MN due to denosumab. This is the first reported case of denosumab-associated MN.
- |||||||||| 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.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Denosumab failure associated with escape from suppression of bone resorption. (Pubmed Central) - Jun 22, 2021
Although this is the second case report of escape from denosumab in osteoporosis and the first in a patient with systemic sclerosis, this phenomenon may be under-reported in patients who do not respond to denosumab. We suggest that clinicians consider the possibility of escape in patients with poor response to denosumab who are compliant, and suggest the measurement of bone turnover markers in these patients.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Secondary Fracture Prevention: Consensus Clinical Recommendations from a Multistakeholder Coalition. (Pubmed Central) - Jun 22, 2021
Individuals beingtreatedfor osteoporosis shouldbe reevaluated for fracture risk routinely, includingvia patienteducationabout osteoporosisandfracturesandmonitoringfor adverse treatment effects.Patients shouldbestronglyencouraged to avoid tobacco, consume alcohol inmoderation atmost, and engage in regular exercise and fall prevention strategies. Finally, referral to endocrinologists or other osteoporosis specialists may be warranted for individuals who experience repeated fracture or bone loss and those with complicating comorbidities (eg, hyperparathyroidism, chronic kidney disease).
- |||||||||| 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
Clinical, Journal: Different fracture risk profile in patients treated with anti-osteoporotic drugs in real-life. (Pubmed Central) - Jun 22, 2021
Denosumab initiators and zoledronic acid initiators had a greater 10-year baseline risk of fracture (54.3%, SD 46.5% and 47.0%, SD 42.0 respectively) than patients initiated on alendronate (24.9%, SD 34.6%) and patients initiated on risedronate (23.9%, SD 24.1%). Using DeFRA, a FRAX™ derived tool, we showed significantly different fracture risk profiles in women who were started on various therapeutic agents for the treatment of osteoporosis in routine clinical practice.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Preclinical, Journal: Dynamic polarization shifting from M1 to M2 macrophages in reduced osteonecrosis of the jaw-like lesions by cessation of anti-RANKL antibody in mice. (Pubmed Central) - Jun 22, 2021
Denosumab-related osteonecrosis of the jaw (DRONJ), which mainly occurs in cancer patients receiving anti-receptor activator NF-kappaB ligand (RANKL) antibody, reduces oral health-related quality of life...Therefore, the developed healing and/or amelioration murine model of DRONJ-like lesions is a useful tool to investigate the histopathology and immunopathology of DRONJ in humans. Dynamic polarization shifting from M1 to M2 macrophages induced by mAb cessation may play an important role in wound healing, rather than angiogenesis and lymphangiogenesis, in DRONJ.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Bisphosphonates and breast cancer - From cautious palliation to saving lives. (Pubmed Central) - Jun 22, 2021
Efficacy seems similar across different biological subgroups of postmenopausal breast cancer with the use of either a nitrogen-containing bisphosphonate such as intravenous zoledronate or daily oral ibandronate as well as the non-nitrogen containing agent, daily oral clodronate. In this overview of evolving role of bisphosphonates in breast cancer, focussing particularly on pamidronate and zoledronate, the long winding development road from the 1970s through to the present day is described and some of the serendipitous findings, "lucky breaks" and regulatory decisions along the way outlined.
- |||||||||| 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.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Review, Journal: Adjuvant therapies for MRONJ: A systematic review. (Pubmed Central) - Jun 22, 2021
A better understanding of denosumab treatment for this patient population is important in clinical practice. It seems that adjuvant surgical therapies for treating MRONJ are beneficial for mucosal healing, but there is only low scientific evidence.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Trends in hip and distal femoral fracture rates in Italy from 2007 to 2017. (Pubmed Central) - Jun 22, 2021
The decreasing trend of hip fractures could be related to a major intake of anti-osteoporosis medications while the increment of distal femoral fractures might be due to population aging and to the use of bisphosphonates and denosumab. Further research is needed to identify and implement interventions to prevent hip and distal femoral fractures.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Patients' first-year adherence to different anti-osteoporotic therapy after hip fractures. (Pubmed Central) - Jun 22, 2021
6-month subcutaneous denosumab injection was preferred over 3-month intravenous injection or daily oral tablets in this elderly population and exhibited significant lower discontinuation rates. However, because of the limited power of the study, further research is required to identify the reasons behind non-adherence and to improve adherence to anti-osteoporosis medications.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: The current standing on the use of denosumab in giant cell tumour of the bone. (Pubmed Central) - Jun 22, 2021
The current recommendation of use of the monoclonal antibody is 3-4 months of neoadjuvant denosumab in patients with advanced GCTB for cases who were not candidates for primary curettage initially, and prolonged use for surgically unsalvageable GCTB. The use of Denosumab in the adjuvant setting to prevent recurrence is not established.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Denosumab and bisphosphonate associated bilateral osteonecrosis of the external auditory canal. (Pubmed Central) - Jun 22, 2021
At 1-year follow-up, bilateral external auditory canals were completely re-epithelialised with no pain or affected hearing. We report the first case of bilateral osteonecrosis of the external auditory canal associated with denosumab and bisphosphonates with successful conservative management.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Review, Journal: Efficacy of medical treatment for Charcot neuroarthropathy: a systematic review and meta-analysis of randomized controlled trials. (Pubmed Central) - Jun 16, 2021
A nonsignificant increase in BMC [SMD 3.39% (- 0.78, 7.56), p = 0.109; I2 = 96.7%], a decrease in foot temperature [SMD - 0.42 °C (- 0.78, - 0.07), p = 0.020; I2 = 0%] and alkaline phosphatase [SMD = -2.51% (- 3.24, - 1.77), p < 0.001; I2 = 0%] was observed with intervention. Limited evidence from available studies does not support the role of anti-resorptive or anti-inflammatory drugs for earlier remission when added to offloading with total contact cast for active CN of the foot.
|
