- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
[VIRTUAL] Temporal Trends in Prescribing of Bone-Directed Therapies in the United States, 2009-2020 (On-Demand) - Feb 2, 2021 - Abstract #ENDO2021ENDO_829;
Use of teriparatide, abaloparatide, and romosozumab remained less than 2% throughout the study period...In the malignancy cohort, alendronate and zoledronic acid were each used in approximately 30% of individuals at the onset of the study, and both declined over the decade...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021.
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[VIRTUAL] Assessment of Hypercalcemia Management at an Academic Institution (On-Demand) - Feb 2, 2021 - Abstract #ENDO2021ENDO_804;
Denosumab was rarely used in both groups...This guideline recommends zoledronic acid alone for asymptomatic malignancy patients, and in combination with calcitonin for symptomatic patients...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
[VIRTUAL] Faculty (On-Demand) - Feb 2, 2021 - Abstract #ENDO2021ENDO_63;
Zoledronate: Zoledronate is usually given at intervals of 1-2 years...Anabolics (teriparatide, abaloparatide, romosozumab): BMD gains during treatment are lost in the months following cessation...In patients having had treatment for >5 years, prevention of rebound bone loss appears to be more difficult, so more intensive bisphosphonate therapy may be required with close monitoring of bone resorption markers and BMD. Patients starting denosumab should be told of this phenomenon so they know that they must not delay injections or discontinue them without transition to a bisphosphonate.
- |||||||||| Prolia (denosumab) / Amgen
Trial completion: Denosumab as an add-on Neoadjuvant Treatment (GeparX) (clinicaltrials.gov) - Feb 2, 2021
P2, N=780, Completed,
Patients starting denosumab should be told of this phenomenon so they know that they must not delay injections or discontinue them without transition to a bisphosphonate. Active, not recruiting --> Completed
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Review, Journal: Role of Bone Targeting Agents in the Prevention of Bone Metastases from Breast Cancer. (Pubmed Central) - Feb 2, 2021
In this context, the potential capability to prevent BM onset in selected BC patients, through the early administration of BTAs, has been explored by several researchers, with the belief that "prevention is better than cure" and that, ultimately, metastatic BC is an incurable condition. Here, we revised the mechanisms of BM development in BC as well as the strategies for selecting high-risk patients suitable for early BTA treatment.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Review, Journal: Schwere Vitamin-D-Intoxikation : Ein Fallbericht. (Pubmed Central) - Feb 2, 2021
Under volume loading, calcium-low-diet, Denosumab for blocking calcium resorption from bone and Ketoconazol to inhibit activation of Vitamin D a normalization of the calcium levels as well as an improvement of renal function could be observed. Loss-of-function mutations in the genes CYP24A1 and SLC34A1, involved in vitamin D metabolism leading to hypercalcemia could not be found in this patient.
- |||||||||| Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment open, Trial completion date: Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users (clinicaltrials.gov) - Feb 2, 2021
P4, N=72, Recruiting,
Loss-of-function mutations in the genes CYP24A1 and SLC34A1, involved in vitamin D metabolism leading to hypercalcemia could not be found in this patient. Not yet recruiting --> Recruiting | Trial completion date: Oct 2024 --> Apr 2024
- |||||||||| Prolia (denosumab) / Amgen
Trial completion date, Trial primary completion date: Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant (clinicaltrials.gov) - Jan 31, 2021
P2, N=180, Recruiting,
Not yet recruiting --> Recruiting | Trial completion date: Oct 2024 --> Apr 2024 Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
[VIRTUAL] Interrogating the cell-of-origin of BRCA1 mutant ovarian cancer to inform targeted strategies for cancer prevention () - Jan 30, 2021 - Abstract #LCC2021LCC_158;
Recent studies have identified a RANK-positive luminal progenitor population of cells that are a putative cell-of-origin of BRCA1mut/+ breast cancer2; this population has proven targetable with the RANK ligand inhibitor denosumab and an international randomised phase III prevention study to assess the efficacy of denosumab treatment in preventative therapy for BRCA1 mutation carriers3 commenced in 2019...Single cell RNA-sequencing has been employed to resolve unique Pax8+ subsets that are over-represented in preneoplastic BRCA1-mutant murine fallopian tube epithelium. Using a Pax8 promoter-driven mouse model of BRCA1-mutant HG-SOC which recapitulates the human disease, we are investigating Pax8+ subsets in ovarian cancer to identify putative targets for ovarian cancer prevention in BRCA1 mutation carriers.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
[VIRTUAL] PFS ANALYSIS OF DMAB VS ZA IN MM PATIENTS BASED ON TREATMENT REGIMEN AND BASELINE CHARACTERISTICS () - Jan 30, 2021 - Abstract #APBMT2020APBMT_39;
Results from the full primary analysis of 1718 patients with NDMM in an international double blind, randomized, controlled phase 3 study that assessed the efficacy of denosumab (Dmab) vs zoledronic acid (ZA) for preventing SREs met its primary end point of non-inferiority time to first SRE. Results from this post-hoc subgroup analysis suggest a more profound PFS benefit in the “intent to undergo ASCT” patient subgroup.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Journal: Osteoporosis: Novel drug, new recommendations (Pubmed Central) - Jan 30, 2021
Regarding denosumab, several studies indicate that post-treatment bone loss may be, at least partially, prevented by zoledronate. Finally, monitoring BMD changes and the T-score reached on any therapy could be used as an indicator of anti-fracture efficacy.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Journal: Iatrogenic risk of osteonecrosis of the jaw? Bone substitutes for dental implants: a warning from Japan. (Pubmed Central) - Jan 29, 2021
ONJ can occur more easily if an antiresorptive agent such as bisphosphonates or denosumab is administered without sufficiently recognizing an intraoral situation...Such restrictions can result in other crucial issues that are beyond the discretion of the dentists; however, dentists have not been warned about such possibilities. The use of antiresorptive agents and bone substitutes for dental implants should be reconsidered to avoid numerous adverse events such as ONJ.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Biomarker, Journal: Methylation of the Sclerostin (SOST) Gene in Serum Free DNA: A New Bone Biomarker? (Pubmed Central) - Jan 29, 2021
We also measured cfDNA methylation in 28 osteoporotic patients at baseline and after 6 months of antiosteoporotic therapy (alendronate, teriparatide, or denosumab)...Our results suggest that serum cfDNA does not originate from blood cells, but rather from bone. However, since we did not confirm changes in this marker after therapy with bone-active drugs, further studies examining the correlation between bone changes of SOST expression and SOST methylation in cfDNA are needed to confirm its potential role as a bone biomarker.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Journal: Osteonecrosis of the jaws (Pubmed Central) - Jan 29, 2021
It has been associated with the use Biphosphonates and denosumab for osteoporosis...There is no consensus about the prevention and treatment of this condition. The aim of this paper is to present a review of the literature with the main characteristics of osteonecrosis of the jaws associated with drugs, together with a proposal for prevention and treatment for these patients.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial completion date: Denosumab and Male Infertility: a RCT (clinicaltrials.gov) - Jan 29, 2021
P2, N=95, Active, not recruiting,
The aim of this paper is to present a review of the literature with the main characteristics of osteonecrosis of the jaws associated with drugs, together with a proposal for prevention and treatment for these patients. Trial completion date: Jun 2021 --> Oct 2021
- |||||||||| Prolia (denosumab) / Amgen, Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date: KEYPAD: Denosumab and Pembrolizumab in Clear Cell Renal Carcinoma (clinicaltrials.gov) - Jan 29, 2021
P2, N=70, Recruiting,
Trial completion date: Jun 2021 --> Oct 2021 Trial completion date: Oct 2021 --> Dec 2022 | Trial primary completion date: Apr 2021 --> Dec 2022
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Romosozumab: A Review in Postmenopausal Osteoporosis. (Pubmed Central) - Jan 23, 2021
Romosozumab had a generally manageable tolerability profile. While further clinical experience is needed to more definitively establish its efficacy and safety, including its CV safety, romosozumab extends the treatment options in postmenopausal women with osteoporosis who have a high risk of fracture and in those who have failed or are intolerant to other available osteoporosis therapy.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Journal: Progress of change in bone mineral density after knee arthroplasty (Pubmed Central) - Jan 23, 2021
Denosumab, bisphosphonates, and teriparatide et al...At present, some inhibitors of bone resorption can decrease BMD loss after knee arthroplasty. However, its long-term efficacy remains to be further explored.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Clinical, Journal: Denosumab versus zoledronic acid for patients with beta-thalassemia major-induced osteoporosis. (Pubmed Central) - Jan 21, 2021
Patients with osteoporosis will receive 1 of the 2 medications; at the end of the year, DEXA scan will be done to compare the response of the 2 medications. The potential risks include drug-related side effects.The outcome will be measured biochemically by measuring bone-specific alkaline phosphatase and type 1 collagen carboxy telopeptide and radiologically by DEXA scan at baseline and 1 year using Z score.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Journal: The Basics of Bone Physiology, Healing, and Osteoporosis. (Pubmed Central) - Jan 21, 2021
Anabolic agents such as teriparatide, abaloparatide, and romosozumab stimulate osteoblastic differentiation and bone formation. All these agents are effective in reducing fracture risk.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Retrospective data, Review, Journal: Bisphosphonates or RANK-ligand-inhibitors for men with prostate cancer and bone metastases: a network meta-analysis. (Pubmed Central) - Jan 16, 2021
When considering bone-modifying agents as supportive treatment, one has to balance between efficacy and acceptability. Results suggest that Zoledronic acid likely increases both the proportion of participants with pain response, and the proportion of participants experiencing adverse events However, more trials with head-to-head comparisons including all potential agents are needed to draw the whole picture and proof the results of this analysis.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Journal: Osteoporosis: Current and emerging therapies targeted to immunological checkpoints. (Pubmed Central) - Jan 15, 2021
Currently, there are basically two monoclonal antibodies for osteoporosis therapy: denosumab and romosozumab. Here we focus on the modern approach to the osteoporosis management and in particular on current and developing biologic drugs targeted to new immunological checkpoints, in the landscape of osteoimmunology.
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