- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
[VIRTUAL] Treatment Sequences with Romosozumab Before or After Antiresorptive Medication (Feed 12) - Oct 8, 2020 - Abstract #ACRARHP2020ACR_ARHP_2736;
In patients treated with Aln or DMAb, transition to Romo can improve BMD, though gains are not as large as those seen when Romo is used first. Since BMD on treatment is a strong surrogate for bone strength, our findings support the concept that high-risk patients should be offered treatment with Romo first, followed by transition to a potent antiresorptive
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
[VIRTUAL] Bone Health in ANCA - Associated Vasculitis Patients () - Oct 8, 2020 - Abstract #ACRARHP2020ACR_ARHP_2287;
In the study however, adherence to the guideline was inadequate in regards to ordering baseline DXA, checking vitamin D levels and starting OP therapy in high and moderate risk patients, especially in patients < 40 yrs. Hence this project identifies a potential QI initiative that can be implemented to improve the above practice methods in patients treated with long term steroids for many rheumatological conditions not just limited to vasculitis.
- |||||||||| thyroxine / Generic mfg.
[VIRTUAL] Pharmacist-Driven Clinic Development for Patients with Incidental Vertebral or Hip Fractures () - Oct 8, 2020 - Abstract #ACRARHP2020ACR_ARHP_714;
The rate of pharmacologic antiresorprtive therapy after admission was 7.5%. The goal in development of this novel pharmacist – driven care pathway and clinic is to create a post-discharge process for patients admitted to the hospital for vertebral or hip fractures to optimize bone health by mitigating modifiable risk factors and increasing appropriate osteoporosis medication prescriptions to reduce the future risk of fractures.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
[VIRTUAL] Osteoporosis Medication Utilization Patterns over Time in the ACR RISE Registry () - Oct 8, 2020 - Abstract #ACRARHP2020ACR_ARHP_703;
Bisphosphonate therapy remains favored as first line therapy for osteoporosis, but overall denosumab was initiated more frequently in 2018 compared to bisphosphonate therapy or anabolics. (Disclaimer: This data was supported by the ACR’s RISE Registry.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial completion date, Trial primary completion date: Denosumab and Male Infertility: a RCT (clinicaltrials.gov) - Oct 8, 2020
P2, N=95, Active, not recruiting,
Transitioning to romosozumab after 12 months of denosumab further improves lumbar spine BMD and maintains total hip BMD. Trial completion date: Jun 2020 --> Jun 2021 | Trial primary completion date: Jun 2020 --> Jan 2021
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg.
[VIRTUAL] Cost-Effectiveness of Binosto (BUFFERED SOLUBLE ALENDRONATE 70 MG) Effervescent Tablet for the Treatment of Postmenopausal Women with Osteoporosis in Italy () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1575;
A previously validated Markov microsimulation model was adjusted to the Italian healthcare setting to estimate the lifetime costs (expressed in €2019) per quality-adjusted life-years (QALY) of Binosto® compared with generic alendronate, denosumab, zoledronic acid and no treatment. This study provides the first economic analysis of an alendronate effervescent tablet, suggesting that Binosto® represents a cost-effective strategy compared with relevant alternative treatments for postmenopausal women with osteoporosis in Italy aged 60 years and over.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., Bonrise (ibandronate sodium) / Elder Pharma
[VIRTUAL] Real-World Effectiveness of Osteoporosis Treatments in Germany () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1314;
CONCLUSIONS : Differences in baseline fracture rate indicate that physicians consider fracture risk when selecting treatment options. Using a within-cohort approach, we show that continued treatment with osteoporosis medications reduced fracture rates in a real-world setting.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: Efficacy and safety of 3-year denosumab therapy for osteoporosis in patients with autoimmune liver diseases. (Pubmed Central) - Oct 3, 2020
We have already reported the efficacy and safety of short-term (1-year) denosumab therapy for osteoporosis in patients with PBC or AIH (1), but the effect of long-term administration remains unknown. In this study, we aimed to clarify the efficacy and safety of long-term denosumab therapy for osteoporosis in patients with PBC or AIH.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: Basic and clinical associations between bone and cancer. (Pubmed Central) - Oct 2, 2020
According to the pathological types of bone destruction caused by the biological characteristics of different primary cancer cells, bone metastases are classified as osteolytic, osteoblastic and mixed types. Herein, we discuss the molecular mechanisms of bone metastasis and the therapeutic strategy with focus on bone metabolism.
- |||||||||| Prolia (denosumab) / Amgen
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy: Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases (clinicaltrials.gov) - Sep 28, 2020
P2, N=50, Active, not recruiting,
Radiotherapy may be a safe and effective treatment choice for spinal SPB; more attention should be paid to reossification. Recruiting --> Active, not recruiting | Trial completion date: Jun 2020 --> Dec 2021 | Trial primary completion date: Dec 2019 --> Dec 2020
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: Benign Pediatric Jaw Lesions at Massachusetts General Hospital Over 13 Years. (Pubmed Central) - Sep 25, 2020
Management of pediatric jaw lesions should consider the biologic behavior of the lesion, maxillofacial development, and growth. Enucleation combined with pharmacologic therapy is a promising strategy for the management of aggressive central giant cell tumors in children.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., Xofigo (radium Ra-223 dichloride) / Bayer
Clinical, Journal: Optimizing skeletal-related events prevention in patients with advanced prostate cancer. (Pubmed Central) - Sep 24, 2020
Effective treatment options include antiresorptive bone-targeted agents such as zoledronic acid and denosumab, and radium-223, a bone-targeting radiopharmaceutical. Although overseas and local guidelines have widely recommended using either zoledronic acid or denosumab for the prevention of SREs in men with mCRPC and associated bone metastases, current evidence suggests that denosumab is superior to zoledronic acid in terms of longer SRE-free time and fewer total SREs observed in patients.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, P1/2 data, PK/PD data, Journal, Checkpoint inhibition: Pharmacodynamics of Pre-Operative PD1 checkpoint blockade and receptor activator of NFkB ligand (RANKL) inhibition in non-small cell lung cancer (NSCLC): study protocol for a multicentre, open-label, phase 1B/2, translational trial (POPCORN). (Pubmed Central) - Sep 22, 2020
When bone-metastasis-related pain is localized, the prescription of topical NSAIDs should be considered, and positive intervention by pharmacists regarding their usage should be promoted. The POPCORN study provides a unique platform for translational research to determine the mechanism of action of a novel proposed combination immunotherapy for cancer.
- |||||||||| Review, Journal: Comparison table: some drugs for postmenopausal osteoporosis. (Pubmed Central) - Sep 20, 2020
The POPCORN study provides a unique platform for translational research to determine the mechanism of action of a novel proposed combination immunotherapy for cancer. No abstract available
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, Ibrance (palbociclib) / Pfizer, Arimidex (anastrozole) / AstraZeneca, Remedica
[VIRTUAL] From Bowl to Bloodstream: A Fishy Case of Foodborne Bacterial Translocation () - Sep 15, 2020 - Abstract #ACG2020ACG_3243;
This case highlights the rare potential for foodborne bacterial translocation in immunocompromised patients and the life-threatening complications that may result. Additionally this serves as a reminder of the importance of food safety in susceptible hosts and the utility of obtaining a thorough history from all patients.
- |||||||||| Avastin (bevacizumab) / Roche
[VIRTUAL] Renal Cell Carcinoma Metastatic to the Stomach: A Case Report () - Sep 15, 2020 - Abstract #ACG2020ACG_1971;
They can also be mucosal or submucosal lesions. Due to this, it is important for both endoscopists and pathologists to keep RCC in the differential with most gastric polyps/ulcers even when they appear benign.
- |||||||||| Prolia (denosumab) / Amgen
New P3 trial: The DENOCHARCOT Trial (clinicaltrials.gov) - Sep 13, 2020
P3, N=38, Not yet recruiting,
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Preclinical, Journal: RANKL-inhibition in Fibrous Dysplasia of bone: A preclinical study in a mouse model of the human disease. (Pubmed Central) - Sep 13, 2020
Previous work suggests that increased bone resorption in FD is driven by RANKL and some studies have shown that the anti-RANKL monoclonal antibody, denosumab, reduces bone turnover and bone pain in FD patients...Taken together, our results demonstrate that the anti-RANKL antibody significantly affected the bone pathology and natural history of FD in the mouse. Pending further work on the prevention and management of relapse after treatment discontinuation, our pre-clinical study suggests that RANKL inhibition may be an affective therapeutic option for FD patients.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: New insight into unexpected bone formation by denosumab. (Pubmed Central) - Sep 12, 2020
Recently, RANKL signaling in osteoblastogenesis and bone formation and RANKL reverse signaling in coupling bone resorption and formation were demonstrated. Thus, here we discuss the roles of RANKL signaling and RANKL reverse signaling in the bone-forming effects of Dmab.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Enrollment change, Trial completion date, Trial primary completion date: Comparative Antiresorptive Efficacy Discontinuation of Denosumab (clinicaltrials.gov) - Sep 10, 2020
P4, N=71, Recruiting,
Thus, here we discuss the roles of RANKL signaling and RANKL reverse signaling in the bone-forming effects of Dmab. N=50 --> 71 | Trial completion date: Dec 2021 --> Jan 2025 | Trial primary completion date: Sep 2021 --> Aug 2024
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Review, Journal: Bone Metabolism in SARS-CoV-2 Disease: Possible Osteoimmunology and Gender Implications. (Pubmed Central) - Sep 10, 2020
In COVID-19 patients, it would be useful to measure the bone metabolism markers and vitamin D. Targeting the RANK-RANKL system should be a priority, and denosumab could represent a safe and effective choice. In the near future, every effort should be made to investigate the fracture risk after SARS-CoV-2 infection.
- |||||||||| Prolia (denosumab) / Amgen
Trial primary completion date: Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma (clinicaltrials.gov) - Sep 9, 2020
P2, N=28, Recruiting,
Key words:Denosumab, osteonecrosis, jaws, radiology. Trial primary completion date: Aug 2020 --> Nov 2021
- |||||||||| Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Trial completion date, Trial initiation date, Trial primary completion date: Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users (clinicaltrials.gov) - Sep 7, 2020
P4, N=72, Not yet recruiting,
Trial primary completion date: Aug 2020 --> Nov 2021 Trial completion date: Apr 2024 --> Oct 2024 | Initiation date: Jul 2020 --> Dec 2020 | Trial primary completion date: Jul 2023 --> Dec 2023
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