- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Preclinical, Journal: Distinct immunopathology in the early stages between different antiresorptives-related osteonecrosis of the jaw-like lesions in mice. (Pubmed Central) - Jun 19, 2022
There is limited information about denosumab-related osteonecrosis of the jaw (DRONJ), unlike bisphosphonate-related ONJ (BRONJ)...Cyclophosphamide (CY) and anti-mouse RANKL monoclonal antibody (mAb) or zoledronate combination therapy (CY/mAb and CY/ZA, respectively) was performed to create ONJ-like lesions in female C57BL/6J mice...Therefore, the distribution of the larger size of F4/80LYVE-1 cells differed in the early stages between different antiresorptive-induced ONJ-like lesions in conjunction with lymphangiogenesis, although the histopathological findings were similar. These findings suggest that the pathogenesis of BRONJ and DRONJ may differ due to the distributions of F4/80LYVE-1 tube-like-structured cells.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Rebound hypercalcemia post-denosumab cessation in metastatic breast cancer. (Pubmed Central) - Jun 15, 2022
She required treatment with intravenous bisphosphonates on three separate occasions in order to achieve long-term normalization of her hypercalcemia. Rebound hypercalcemia post-denosumab cessation is a rare but serious complication that clinicians should be aware of.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Observational data, Journal: Effect of follow-up raloxifene therapy after denosumab discontinuation in postmenopausal women. (Pubmed Central) - Jun 15, 2022
Follow-up raloxifene therapy after denosumab discontinuation resulted in a decrease in bone mass to the pre-denosumab levels and a rebound increase of bone turnover markers. Therefore, raloxifene administered sequentially after denosumab discontinuation was not effective in preventing rebound phenomenon.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Bone metastases in non-small cell lung cancer: a narrative review. (Pubmed Central) - Jun 14, 2022
There is data supporting use of bisphosphonates and/or denosumab, and these should be considered in all patients with bone metastases...Predicting development and progression of bone metastases could allow earlier and targeted therapy in patients with bone metastases. Predicting and evaluating response to conventional chemotherapy and immune checkpoint inhibitors in NSCLC patients with bone metastases remains an unmet need and merits further study.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial completion date, Trial initiation date, Trial primary completion date: Denosumab and Osteoporotic Vertebral Compression Fracture (clinicaltrials.gov) - Jun 13, 2022
P2/3, N=120, Recruiting,
Predicting and evaluating response to conventional chemotherapy and immune checkpoint inhibitors in NSCLC patients with bone metastases remains an unmet need and merits further study. Trial completion date: Sep 2022 --> Jun 2022 | Initiation date: Sep 2021 --> Jan 2020 | Trial primary completion date: Mar 2022 --> Jun 2022
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Drug therapy for bone metastasis of malignant tumor: theory, progress, and potential. (Pubmed Central) - Jun 11, 2022
At the present, only bisphosphonates and denosumab are currently approved for the prevention of skeletal-related events...The review aimed to generalize the basic theory of bone metastasis and major put emphasis on the development of fundamental and potential target drugs in the behavior of bone metastasis. The summary of the drug development process helps to provide ideas for finding new and effective treatments for bone metastasis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Effect of denosumab compared to risedronate on bone strength in patients initiating or continuing glucocorticoid treatment. (Pubmed Central) - Jun 11, 2022
To conclude, this HR-pQCT study shows that denosumab is superior to risedronate in terms of preventing FL loss at the distal radius and tibia in GC-I and in increasing FL at the radius in GC-C, based on significant differences in changes in the cortical and trabecular bone compartments between treatment groups in GC-I and GC-C. These results suggest that denosumab could be a useful therapeutic option in patients initiating GC-therapy or on long-term GC-therapy and may contribute to treatment decisions in this patient population.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Giant-cell tumor of bone in 2022 (Pubmed Central) - Jun 9, 2022
The mutated H3.3 G34W protein (90% of cases) can be easily detected by immunohistochemistry, even on small samples. Many tumors or bone pseudotumors contain osteoclast-like giant cells, cells of the bone microenvironment, and should not be confused with GCT: mainly brown tumor of hyperparathyroidism, aneurysmal bone cyst, chondroblastoma, non-ossifying fibroma and central giant cell granuloma.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Enrollment closed, Trial completion date, Trial primary completion date: Comparative Antiresorptive Efficacy Discontinuation of Denosumab (clinicaltrials.gov) - Jun 8, 2022
P4, N=51, Active, not recruiting,
No abstract available Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Aug 2023 | Trial primary completion date: Aug 2024 --> Feb 2023
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Deprescribing in Palliative Cancer Care. (Pubmed Central) - May 30, 2022
The aim of this review is to give some advice according to when and how to deprescribe medications in palliative cancer care according to current evidence and clinical praxis. The review includes antihypertensive drugs, statins, anti-coagulants, aspirin, anti-diabetics, proton pump inhibitors, histamin-2-blockers, bisphosphonates denosumab, urologicals, anti-depressants, cortisone, thyroxin and vitamins.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Analysis of Serum Proteome after Treatment of Osteoporosis with Anabolic or Antiresorptive Drugs. (Pubmed Central) - May 30, 2022
Among patients treated with denosumab, we observed significant differences in the levels of 10 proteins, which were also enriched in the pathways related to the innate immune system (FDR q 3 × 10). These results suggest that the innate immune system may be involved in the response to antiosteoporosis drugs.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, IO biomarker: Improved Characteristics of RANKL Immuno-PET Imaging Using Radiolabeled Antibody Fab Fragments. (Pubmed Central) - May 30, 2022
These results suggest that the innate immune system may be involved in the response to antiosteoporosis drugs. Here, we report on a novel RANKL PET imaging agent, [Cu]Cu-NOTA-denos-Fab, that allows for fast tumor imaging with improved imaging contrast when compared with its antibody counterpart, showing promise as a potential PET RANKL imaging tool for future clinical applications.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Xofigo (radium Ra-223 dichloride) / Bayer
Acute and chronic prostatitis (Carl Zeiss Hall on the right) - May 29, 2022 - Abstract #NORDKONGRESS2022NORDKONGRESS_232;
Half of the patients received parallel therapy with ARTA's. In contrast to ERA-223, however, this did not lead to an increased fracture rate, although the majority of patients received osteoprotection at the same time.
- |||||||||| Xofigo (radium Ra-223 dichloride) / Bayer
d-uo care study on therapy with radium-223: data from a retrospective survey (#57) (Christian Reichart (right+middle)) - May 29, 2022 - Abstract #NORDKONGRESS2022NORDKONGRESS_230;
Half of the patients received parallel therapy with ARTA's. In contrast to ERA-223, however, this did not lead to an increased fracture rate, although the majority of patients received osteoprotection at the same time.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Osteoprotection under androgen deprivative therapy in non-metastatic prostate cancer (M0-PCa): results of a survey by d-uo (#66) (Christian Reichart (right+middle)) - May 29, 2022 - Abstract #NORDKONGRESS2022NORDKONGRESS_39;
134/183 patients (73.2%) were treated with denosumab and 49/183 patients (26.8%) with a bisphosphonate...Only in every third patient was the osteoprotective therapy started at the same time as the ADT. Most patients with osteoprotective therapy also received calcium and vitamin D. The supply situation with regard to osteoprotective therapy in patients with M0-PCa on long-term ADT is suboptimal.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Case Report - Rare Cause of Postmenopausal Vaginal Bleeding (#39) (Christian Reichart (right+middle)) - May 29, 2022 - Abstract #NORDKONGRESS2022NORDKONGRESS_34;
With an intermediate risk profile according to the IMDC criteria, first-line drug therapy with nivolumab and ipililumab followed...Osteoprotective therapy with denosumab (XGEVA®) and second-line therapy with cabozantinib were then started...Vaginal metastases from renal cell carcinoma are very rare and have only been described in a few case reports. However, they can be the cause of vaginal bleeding.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Journal: Risk factors of fracture following curettage for bone giant cell tumors of the extremities. (Pubmed Central) - May 29, 2022
Additional plate fixation should be considered when curettage and cement filling without bone grafting are performed in patients with GCTB of the femur. This should be specially performed for those patients with a pathological fracture at presentation.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Bone Health in Metastatic Cancer. (Pubmed Central) - May 27, 2022
Osteoporotic, as well as cancer patients, may also benefit from periodic monitoring of the ARDs therapy in order to prevent MRONJ. The role of health care providers and specially nurses on identifying patients at risk of complications from these antiresorptive agents, and providing information on how to prevent them, is essential for health and quality of life maintenance in these patients.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Pharmacological Prevention and Management of Skeletal-Related Events and Bone Loss in Individuals with Cancer. (Pubmed Central) - May 27, 2022
The role of health care providers and specially nurses on identifying patients at risk of complications from these antiresorptive agents, and providing information on how to prevent them, is essential for health and quality of life maintenance in these patients. Nurses and nurse practitioners should be aware of the efficacy data of bisphosphonates and denosumab but also should be well-versed in the appropriate administration of these agents, potential side effect profiles, timely assessment, and interventions to optimize quality of life.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Enrollment closed: Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration (clinicaltrials.gov) - May 26, 2022
P4, N=37, Active, not recruiting,
Nurses and nurse practitioners should be aware of the efficacy data of bisphosphonates and denosumab but also should be well-versed in the appropriate administration of these agents, potential side effect profiles, timely assessment, and interventions to optimize quality of life. Recruiting --> Active, not recruiting
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Therapeutic Options in the Management of Aromatase Inhibitor-Associated Bone Loss. (Pubmed Central) - May 26, 2022
AI, that are the pillar of the systemic treatment for patients with hormone receptorpositive breast cancer, are associated with different side effects, and in particular, osteoporosis and fractures. Both bisphosphonates and denosumab are able to prevent this negative effect.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Journal: A 5-year retrospective cohort study of denosumab induced medication related osteonecrosis of the jaw in osteoporosis patients. (Pubmed Central) - May 25, 2022
The other patient underwent a tooth extraction without osteoporosis treatment, and non-identified MRONJ developed after denosumab administration. MRONJ cases reported in this study show that MRONJ can develop as chronic inflammation without invasive dental treatment; therefore, implementing preventive dental treatment before initiating denosumab treatment is necessary to reduce the occurrence of MRONJ.
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