- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Review, Journal: Bone-modifying Agents (BMAs) in Breast Cancer. (Pubmed Central) - Feb 5, 2022
Zoledronic acid (ZA) or DEN reduces skeletal metastases complications, including pathological fracture, spinal cord compression, or the necessity for radiation or surgery to bone...There are insufficient data to support DEN in this setting. Herein, this narrative review covers the mechanism of action of BMA, randomized clinical trials, and adverse events, both common and rare.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Observational data, Journal, BRCA Biomarker: Determinants of serum adiponectin levels: a cross-sectional study. (Pubmed Central) - Feb 3, 2022
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
Biomarker, Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Denosumab and MRI Breast Imaging (clinicaltrials.gov) - Feb 3, 2022
P2, N=30, Completed,
The prospectively randomized double-blind BRCA-P trial is currently investigating the preventative effect of denosumab in healthy BRCA1 germ line mutation carriers. Recruiting --> Completed | N=44 --> 30 | Trial completion date: Nov 2020 --> Aug 2021 | Trial primary completion date: Nov 2020 --> Aug 2021
- |||||||||| Prolia (denosumab) / Amgen
Trial completion, Trial completion date: Effect of Denosumab on Inflammatory Osteolytic Lesion Activity in Total Hip Arthroplasty (clinicaltrials.gov) - Feb 2, 2022
P2, N=24, Completed,
Recruiting --> Completed | N=44 --> 30 | Trial completion date: Nov 2020 --> Aug 2021 | Trial primary completion date: Nov 2020 --> Aug 2021 Active, not recruiting --> Completed | Trial completion date: Jul 2020 --> Dec 2021
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal, HEOR: Which injected antiosteoporotic medication is worth paying for? A cost-effectiveness analysis of teriparatide, zoledronate, ibandronate, and denosumab for postmenopausal osteoporotic women in China. (Pubmed Central) - Feb 1, 2022
Among postmenopausal osteoporotic women in China, denosumab therapy is cost-effective at all ages examined from the health care payer perspective, compared with teriparatide, zoledronate, or ibandronate. This study will help clinicians and policymakers make better decisions about the relative economic value of osteoporosis treatments in China.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Management of Osteoporosis in Men: A Narrative Review. (Pubmed Central) - Feb 1, 2022
Hypogonadal patients may be treated with testosterone replacement therapy. Given that the fractures related to mortality are higher in men than in women, treating male subjects with osteoporosis is of the utmost importance in clinical practice, as it may impact on mortality even more than in women.
- |||||||||| Prolia (denosumab) / Amgen
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant (clinicaltrials.gov) - Jan 31, 2022
P2, N=30, Active, not recruiting,
Given that the fractures related to mortality are higher in men than in women, treating male subjects with osteoporosis is of the utmost importance in clinical practice, as it may impact on mortality even more than in women. Recruiting --> Active, not recruiting | N=150 --> 30 | Trial completion date: Aug 2023 --> Apr 2023 | Trial primary completion date: Aug 2022 --> Apr 2023
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Pharmacist-led osteoporosis telephone service () - Jan 30, 2022 - Abstract #BSR2022BSR_397;
Such clinics could be implemented across other areas of our rheumatology service, if clinically appropriate; reducing unnecessary patient contact, reducing consultant work load and optimally utilizing skills of the wider multi-disciplinary team. Face-to-face consultations still have an essential role where physical examination may be required, or patients have communication barriers.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Risks vs. benefits of switching therapy in patients with postmenopausal osteoporosis. (Pubmed Central) - Jan 29, 2022
We recommend first using osteoanabolic agents in postmenopausal women with severe osteoporosis. In addition, identifying predictors of the efficacy and side effects of treatment may help prevent the inappropriate use of drugs for the treatment of osteoporosis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Lower response to denosumab in diabetes patients on hemodialysis. (Pubmed Central) - Jan 29, 2022
In addition, identifying predictors of the efficacy and side effects of treatment may help prevent the inappropriate use of drugs for the treatment of osteoporosis. Denosumab improved bone density and osteoclastic activity in HD patients, with a lower response in patients with diabetes.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Lynparza (olaparib) / Merck (MSD), AstraZeneca
Genomic medicine meets cancer interception (Hall B-C, Convention Center) - Jan 28, 2022 - Abstract #AACR2022AACR_397;
The adjuvant study of the PARP inhibitor olaparib in high risk BRCA-associated breast cancer demonstrated an improvement in event free survival along with a favorable safety profile, paving the way for further work in the prevention space...As our molecular understanding of BRCA haploinsufficiency improves, so too will our options for cancer interception. All of this work could lead to a halo effect with impact on sporadic cancer interception.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Review, Journal: Bone Mineral Density Loss and Fracture Risk After Discontinuation of Anti-osteoporotic Drug Treatment: A Narrative Review. (Pubmed Central) - Jan 27, 2022
Therefore, in modern fracture risk management, continuous monitoring and treatment is required, as is the case with other chronic diseases, to sustain the benefits of therapy, especially in denosumab- and romosozumab-treated patients. The exception is alendronate and zoledronic acid, in these patients a discontinuation of drug therapy of 1 year or more might be acceptable.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Osteoporosis (Pubmed Central) - Jan 27, 2022
The practical management of denosumab discontinuation is finally better understood. Finally, with the arrival of a new treatment, Burosumab, we are experiencing a therapeutic revolution for rare hypophosphatemic diseases.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Macrophage Involvement in Medication-Related Osteonecrosis of the Jaw (MRONJ): A Comprehensive, Short Review. (Pubmed Central) - Jan 26, 2022
Antiresorptive agents such as bisphosphonates (BP) and denosumab are commonly prescribed for the management of primary bone malignancy, bone metastasis, osteoporosis, Paget disease, or other bone disorders...This current review attempted to elucidate the effects of antiresorptive medications on several aspects of macrophage activity in relation to the complex inflammatory microenvironment of MRONJ. Collectively, unravelling the mode of action and extent of macrophages' potential contribution in MRONJ occurrence will provide novel insight in disease pathogenesis and potentially identify intrinsic therapeutic targets.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Study of imaging changes following preoperative denosumab for giant cell tumor of bone. (Pubmed Central) - Jan 26, 2022
Following treatment, the decrease in the blood supply gradually reduces over time. Therefore, for the purpose of reducing intra-operative bleeding and facilitating surgery, application of denosumab treatment is not recommended more than three months before surgery.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Treatment of cystic fibrosis related bone disease. (Pubmed Central) - Jan 26, 2022
In this review, we also summarize screening and non-pharmacologic treatment of CFBD and describe the various options available for the pharmacotherapy of CFBD. We address the prospect of CFTR modulators on bone health while awaiting long-term trials to describe the effects of these medications on bone health.
- |||||||||| Journal: A BRIEF SYNOPSIS OF MONOCLONAL ANTIBODY FOR THE TREATMENT OF VARIOUS GROUPS OF DISEASES. (Pubmed Central) - Jan 26, 2022
Finally, we shall discuss two mAbs that are IL-6 antagonists, Tocilizumab and Siltuximab, which are in ongoing clinical trials as potential treatments of COVID-19. The mAbs have profound benefits against chronic and malignant conditions, and the overall purpose of this review is to illustrate the basic pharmacological profiles of mAbs that physicians may find useful in establishing their management protocols.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Effects of osteoporosis medications on bone fracture in patients with chronic kidney disease. (Pubmed Central) - Jan 21, 2022
Stratified analysis showed that bisphosphonates users have most benefits in the reduction of CV events (HR, 0.26; 95% CI, 0.11 to 0.64; p=0.003). In conclusion, osteoporosis medications did not reduce the risk of bone fractures, or mortality, but improved CV outcomes in patients with CKD.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Denosumab-induced hypocalcemia in a patient with hyperthyroidism: a case report. (Pubmed Central) - Jan 18, 2022
Subsequently, the patient's symptoms improved, and her serum calcium level normalized. The risk of denosumab-induced hypocalcemia may be increased in patients with diseases related to high bone turnover, such as hyperthyroidism; therefore, caution is needed.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Review, Journal: Osteogenesis Imperfecta: Current and Prospective Therapies. (Pubmed Central) - Jan 13, 2022
The main disadvantages of these therapies are their relatively weak effectiveness, lack of effects in some patients or cytotoxic side effects. Experimental approaches, particularly those based on stem cell transplantation and genetic engineering, seem to be promising to improve the therapeutic effects of OI.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: The pathophysiology of immunoporosis: innovative therapeutic targets. (Pubmed Central) - Jan 8, 2022
Intraoperative MRI could contribute to the reduction of residual tumor tissue and it may prevent recurrence of GCTB after denosumab therapy. This review presents alternative pathways in the pathophysiology of osteoporosis, along with some recent therapeutic breakthroughs to restore bone homeostasis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, Retrospective data, Journal, Checkpoint inhibition: Immune Checkpoint Inhibitors With or Without Bone-Targeted Therapy in NSCLC Patients With Bone Metastases and Prognostic Significance of Neutrophil-to-Lymphocyte Ratio. (Pubmed Central) - Jan 8, 2022
Although immune-checkpoint inhibitors (ICIs) have dramatically changed the therapeutic landscape of NSCLC, little information is available on BMs from NSCLC treated with ICIs alone or in association with bone-targeted therapy (BTT) such as zoledronate or denosumab...Forty-six (43.4%) patients with BM NSCLC underwent first- or further-line therapy with ICIs: 28 (60.8%) received nivolumab, 9 (19.6%) pembrolizumab, and 9 (19.6%) atezolizumab...NLR ≤5 had a positive impact on OS. BTT appears to have a synergistic effect when used in combination with ICIs, improving patient survival.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Review, Journal: Therapeutic efficacy of denosumab for rheumatoid arthritis: a systematic review and meta-analysis. (Pubmed Central) - Jan 7, 2022
The changes in the modified total sharp, erosion and joint space narrowing scores at 12 months after denosumab treatment were significantly smaller with denosumab than with placebo, although the DAS did not change after denosumab treatment. Although denosumab has an inhibitory effect on the bone resorption in RA, its effects might be influenced by the age and sex of RA patients, but not by glucocorticoid use.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Intravital imaging reveals novel bone and tumour cell interactions: Implications for bone targeted therapeutic control of metastatic growth. () - Jan 7, 2022 - Abstract #LCC2022LCC_218;
Anti-resorptive agents, such as bisphosphonates and Denosumab, are mainstay treatment for bone metastatic disease, reducing further bone loss and fracture...Through visualising tumour cell and osteoclast interactions in real time in vivo we are revealing new insight into how modifying this interaction, with anti-resorptive agents, may supress tumour cell reactivation and prevent metastatic outgrowth. The outcomes of this work may prevent the outgrowth of cancers in bone, thereby impacting significantly on cancer survivorship and quality of life.
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