Podcasts about Denosumab

Drs. McClung and Singer delve into common questions and clinical conundrums encountered in managing osteoporosis and fractures, including calcium use and dental procedures, in patients with osteoporosis.

Are you confident in managing patients on bisphosphonates or biologics? Which medications increase the risk of medication-related osteonecrosis of the jaw (MRONJ)? How do you decide when to extract a tooth and when to refer to a specialist? In this episode, Jaz is joined by oral surgery consultant Dr. Pippa Cullingham to explore the complexities of MRONJ. They break down the key risk factors, share expert advice on when to proceed with extractions, and discuss the latest guidelines for managing patients at risk. They also discuss the importance of early assessment - by identifying at-risk teeth early, you can help prevent serious complications and ensure the best outcome for your patients. https://youtu.be/KnQoI8Z-FhM Watch PDP215 on Youtube Protrusive Dental Pearl: it is so important to assess patients before they start taking high-risk medications like bisphosphonates or biologics, using radiographs to identify potential issues. Extractions should ideally be done before medication starts to avoid complications, as MRONJ risk increases once treatment begins. Key Takeaways: Medication-related osteonecrosis of the jaw concerns medications other than bisphosphonates. Risk assessment is crucial when considering dental extractions for patients on certain medications. Guidelines from the Scottish Dental Clinical Effectiveness Partnership are valuable resources for dentists. Higher-risk patients require careful management and communication with their medical teams. Denosumab has a different risk profile compared to bisphosphonates. Patients on long-term bisphosphonates may still have risks even after stopping the medication. Dentists should feel empowered to manage certain extractions in primary care with proper guidance. The decision to extract a tooth should weigh the risks and benefits for the patient. Always assess the patient's risk before extraction. Eight weeks is a critical time for assessing healing. Antibiotics are not recommended for preventing MRONJ in the UK. Radiotherapy history significantly impacts extraction risk. Referral to specialists may be necessary for high-risk patients. Highlights of this episode: 02:15 Protrusive Dental Pearl 03:52  Interview with Dr. Pippa Cullingham: Insights and Experiences 06:40 Medications and Their Risks 10:02 MRONJ: Incidence and Prevalence 13:13 Biologics and other medications 14:19 Guidelines and Best Practices 17:22 Managing High-Risk Patients 25:03 Prophylactic Antibiotics  26:55 Risk Assessment 28:47 Radiotherapy & ORN Risk 31:49 Tips and Key Takeaways 33:32 New Medications & Prevention Strategies For the best approach to managing MRONJ, check the SDCEP Guidelines and the American White Paper. This episode is eligible for 0.5 CE credits via the quiz on Protrusive Guidance.  This episode meets GDC Outcomes B and C. AGD Subject Code: 730 ORAL MEDICINE, ORAL DIAGNOSIS, ORAL PATHOLOGY (Diagnosis, management and treatment of oral pathologies) Dentists will be able to - 1. Be aware of the medications that increase the risk of MRONJ. 2. Learn how to assess the risk of MRONJ in patients, particularly before starting high-risk medications. 3. Understand when to proceed with extractions and when to refer patients to specialists for management. If you liked this episode, check out PDP206 - White Patches

On this episode of the Top 200 drugs podcast from Real Life Pharmacology, I cover medications 131-135 which include enoxaparin, methylphenidate, rosuvastatin, denosumab, and dabigatran. Enoxaparin is an injectable anticoagulant that can cause heparin-induced thrombocytopenia. Methylphenidate is a stimulant medication that can be used to treat ADHD. Cardiovascular adverse effects are possible. Rosuvastatin inhibits HMG-CoA Reductase which helps lower LDL in the management of hypercholesterolemia. Denosumab is a monoclonal antibody that is indicated for osteoporosis and may cause hypocalcemia. Dabigatran was one of the first direct oral anticoagulants to be produced. It is dosed twice daily and has warnings about use in patients over the age of 75.

Drs. Cosman and Bilezikian discuss the optimal use of denosumab in patients with postmenopausal osteoporosis and examine how RANK ligand inhibitors differ from bisphosphonate medications. They also share insight into how they personalize therapy with denosumab in patients with postmenopausal osteoporosis.

Show notes 1. Biosimilars Check-In: Application Acceptances, European Approvals, New Partnerships 2. Overcoming Economic, Noneconomic Barriers to Biosimilar Adoption in Oncology 3. EHA 2024: Rituximab Biosimilars Improve Quality of Life, Infusion-Related Reactions 4. New Data Show Safety of Ado-Trastuzumab, Trastuzumab Biosimilars in HER2+ Cancers 5. ASCO Posters Reflect on Reimbursement Trends, Combination Therapies Involving Biosimilars 6. ASCO 2024 Posters Showcase Positive Data on Denosumab, Pegfilgrastim Biosimilars 7. Authors Spotlight Long-Term Solutions to Ensure Biosimilar Market Sustainability 8. Part 2: Unlocking the Potential of Biosimilars to Improve Health Equity

To learn more about the approval of denosumab-bddz, click here. To watch Curtis and Edgerton speak on the approval of denosumab-bddz and osteoporosis treatment, click here. To learn more about the ROSALIA study (NCT05405725), click here.  Extra content: To read more about the Biosimilars Council position paper on how to improve biosimilar development, click here.

Drs. Kristi Tough DeSapri and Pauline M. Camacho share their insights into best practices for pharmacological management of postmenopausal osteoporosis in women at a high risk for fracture.

Here is information on the latest US FDA approvals, the week of March 4 – March 8, 2024 ·         ChatGPT4 in medical writing and editing—visit learnAMAstyle.com ·       Nascentmc.com for medical writing assistance for your company. Visit nascentmc.com/podcast for full show notes   - **OTC Glucose Monitor**: The FDA has approved the Dexcom Stelo Glucose Biosensor System for over-the-counter sale, a first for a continuous glucose monitor. Designed for people aged 18 and older not using insulin, it helps manage diabetes with oral medications or monitors the impact of diet and exercise on blood sugar levels. Scheduled for release in Summer 2024, the system offers a 15-day sensor wear time and does not alert users to low blood sugar episodes.   - **Semaglutide in CVD Risk**: The FDA has approved semaglutide (Wegovy) for reducing cardiovascular risk in adults with known heart disease who are overweight or obese, specifically targeting the reduction of major adverse cardiovascular events. This approval makes semaglutide the first weight-loss medication also indicated for preventing life-threatening cardiovascular events in patients with established cardiovascular disease and obesity or overweight.   - **Juvederm Additional Indication**: JUVÉDERM® VOLUMA® XC, a hyaluronic acid dermal filler, has received FDA approval for treating moderate to severe temple hollowing in adults over 21, marking it as the first HA filler for this purpose. With effects lasting up to 13 months, clinical studies show significant improvement and patient satisfaction with facial symmetry post-treatment. This approval highlights Allergan Aesthetics' commitment to innovation in aesthetic treatments.   - **Nivolumab in mUC**: The FDA approved nivolumab in combination with cisplatin and gemcitabine for first-line treatment of metastatic urothelial carcinoma, based on significant improvements in survival outcomes from the CHECKMATE-901 trial. This expands nivolumab's indications, which include treatments for melanoma and lung cancer, among others, demonstrating its broad applicability in cancer treatment.   - **Zanubrutinib in FL**: The FDA has granted accelerated approval to zanubrutinib and obinutuzumab for relapsed or refractory follicular lymphoma patients after two or more systemic therapies. This combination targets key pathways in B cell survival, offering a new treatment option for patients. Approval was based on the ROSEWOOD trial, highlighting significant patient outcome improvements.   - **Donanemab and Alzheimer's**: The FDA has postponed the decision on the approval of Eli Lilly's donanemab for Alzheimer's treatment to convene an advisory meeting for further examination of safety and efficacy data, indicating a significant delay. This reflects the complex nature of Alzheimer's drug approval and Eli Lilly's confidence in donanemab's potential benefits.   - **Tocilizumab Biosimilar**: Tyenne® (tocilizumab-aazg), the first FDA-approved biosimilar to Actemra® for various inflammatory diseases, is now available in both IV and subcutaneous formulations. This approval introduces a new treatment option for patients with conditions like rheumatoid arthritis and juvenile idiopathic arthritis, emphasizing advancements in biosimilar medications.   - **Denosumab Biosimilars**: The FDA approved Jubbonti and Wyost as interchangeable biosimilars to Prolia and Xgeva, respectively, marking a first for biosimilars targeting the RANKL inhibitor used in osteoporosis and cancer-related bone conditions. These approvals offer new treatment options for managing bone health, underlining the importance of biosimilar development in expanding patient care.   - **Clobetasol Propionate Eye Drops**: The FDA's approval of clobetasol propionate 0.05% eye drops for post-operative eye inflammation and pain introduces the first ophthalmic formulation of this corticosteroid and the first new steroid in ophthalmology in over 15 years. Developed using proprietary nanoparticle technology for twice-daily dosing, this approval offers a new option for effective pain and inflammation management post-eye surgery.

Check out “Heard on the Street” recorded during Day 3 of the nPOD 2024 scientific meeting. Hear from Dr. Rupangi Vasavada at City of Hope as she talks about a recent clinical trial grant they received for testing Denosumab.

We are starting a supportive care series, because these topics comes up very often in oncology. This week's episode will be focusing on Bone Modifying Agents, such as bisphosphonates and Denosumab - when they are indicated, mechanism of action, and key pearls/toxicities.

Listen to FDA Drug Safety Podcast titled, FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab).

Drs Sandhya Srinivas and Rana R. McKay discuss bone health and survivorship, including risk factors and potential side effects with androgen deprivation therapy in patients with prostate cancer. Relevant disclosures can be found with the episode show notes on Medscape (https://www.medscape.com/viewarticle/988732). The topics and discussions are planned, produced, and reviewed independently of advertisers. This podcast is intended only for US healthcare professionals. Resources Metastases in Prostate Cancer https://pubmed.ncbi.nlm.nih.gov/29661810/ Do Dietary Calcium and Vitamin D Matter in Men With Prostate Cancer? https://pubmed.ncbi.nlm.nih.gov/29765146/ Zoledronic Acid: A Review of Its Use in the Management of Bone Metastases and Hypercalcaemia of Malignancy https://pubmed.ncbi.nlm.nih.gov/12558465/ Denosumab in Osteoporosis https://pubmed.ncbi.nlm.nih.gov/24289327/ Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer https://pubmed.ncbi.nlm.nih.gov/23863050/ Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on Skeletal Events in Patients With Bone Metastases: A Randomized Clinical Trial https://pubmed.ncbi.nlm.nih.gov/28030702/ The Prevention of Fragility Fractures in Patients With Non-Metastatic Prostate Cancer: A Position Statement by the International Osteoporosis Foundation https://pubmed.ncbi.nlm.nih.gov/29088899/ Decreased Fracture Rate by Mandating Bone Protecting Agents in the EORTC 1333/PEACEIII Trial Combining Ra223 With Enzalutamide Versus Enzalutamide Alone: An Updated Safety Analysis. https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.5002 Addition of Radium-223 to Abiraterone Acetate and Prednisone or Prednisolone in Patients With Castration-Resistant Prostate Cancer and Bone Metastases (ERA 223): A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Trial https://pubmed.ncbi.nlm.nih.gov/30738780/

In this podcast, Prof. Igor Tsaur (DE), chief editor of the UROONCO PCa editorial board talks with Dr. Craig Jones (GB),  from Salford Royal and Christie Hospitals, about his recent presentation at AUA2023, "Clinical fracture incidence in metastatic hormone-sensitive prostate cancer (mHSPC) and risk-reduction following addition of zoledronic acid to androgen deprivation therapy (ADT) with or without docetaxel (Doc): Long-term results of two phase 3 trials from the STAMPEDE platform protocol."Mr. Craig Jones answers the following questions: Could you distinguish osteoporotic from pathological fractures in your analysis based on routinely-collected healthcare data? Would a higher rate of pathological fractures explain the higher incidence of clinical fracture events in the M1 as compared to M0 subgroup?Are there data on symptomatic skeletal events as opposed to skeletal related events as a more relevant endpoint for health related quality of life?Risk of osteoporosis when utilising ADT+Docetaxel as compared to ADT+NHA?Denosumab outperformed Zoledronic acid for prevention of SRE in mCRPC. How would you compare both drugs in mHSPC? To keep up to date with prostate cancer developments, you can also visit our educational platform, UROONCO Prostate Cancer.

Could bacteria be responsible for the development of Parkinson's disease? Find out about this and more in today's PV Roundup podcast.

Recently the Endocrine Society published a new clinical practice guideline entitled, “Treatment of Hypercalcemia of Malignancy in Adults: An Endocrine Society Clinical Practice Guideline.” What exactly is hypercalcemia of malignancy? What are its symptoms? How is it treated? And what do the guidelines recommend? To help answer these questions, host Aaron Lohr talks with Ghada El-Hajj Fuleihan, MD, MPH, professor of medicine at the American University in Beirut in Lebanon. She is the chair of the Society working group that developed this guideline. For helpful links or to hear more podcast episodes, visit https://www.endocrine.org/podcast

Recently the Endocrine Society published a new clinical practice guideline entitled, “Treatment of Hypercalcemia of Malignancy in Adults: An Endocrine Society Clinical Practice Guideline.” What exactly is hypercalcemia of malignancy? What are its symptoms? How is it treated? And what do the guidelines recommend? To help answer these questions, host Aaron Lohr talks with Ghada El-Hajj Fuleihan, MD, MPH, professor of medicine at the American University in Beirut in Lebanon. She is the chair of the Society working group that developed this guideline. Show notes are available at https://www.endocrine.org/podcast/enp68-hypercalcemia-of-malignancy — for helpful links or to hear more podcast episodes, visit https://www.endocrine.org/podcast

Recently the Endocrine Society published a new clinical practice guideline entitled, “Treatment of Hypercalcemia of Malignancy in Adults: An Endocrine Society Clinical Practice Guideline.” What exactly is hypercalcemia of malignancy? What are its symptoms? How is it treated? And what do the guidelines recommend? To help answer these questions, host Aaron Lohr talks with Ghada El-Hajj Fuleihan, MD, MPH, professor of medicine at the American University in Beirut in Lebanon. She is the chair of the Society working group that developed this guideline. Show notes are available at https://www.endocrine.org/podcast/enp68-hypercalcemia-of-malignancy — for helpful links or to hear more podcast episodes, visit https://www.endocrine.org/podcast

FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)

En el video de hoy revisamos uno de los medicamentos más utilizados para el manejo de la osteoporosis, el anticuerpo monoclonal denosumab, revisamos cómo funciona, los eventos adversos de este fármaco, a quién se le administra y cómo.Checa el video aquí: https://youtu.be/p_D4Zg_BOfoVisita nuestra tienda en línea para comprar nuestros libros y material educativo:https://bit.ly/3i6eAnGSi necesitas una consulta aquí nos puedes encontrar:http://bit.ly/3aUSt12Ayúdanos a encontrar los mejores hospitales para estudiar:https://bit.ly/36o82LXUnete al equipo de Mecenas en YouTube desde 1 dolar al mes: http://bit.ly/2O1AtsXSupport the show

Katharine and Skye had never met each other, but they shared something in common. Both women carry the BRCA-1 gene mutation. This is an inherited gene which increases their chance of developing breast cancer by 70% and ovarian cancer by 40% throughout their lifetime. Until now, life-changing invasive surgery and regular breast screening have been the only options available for women like Katharine and Skye. However, the BRCA-P clinical trial aims to open up a new treatment opportunity for women with this gene mutation. BRCA-P is a preventative trial, which is testing the effectiveness of a drug called Denosumab in preventing breast cancer for these women.

On this episode, I discuss denosumab pharmacology, adverse effects, clinical pearls, and drug interactions. Whenever I see an osteoporosis medication like denosumab used, I review the medications to ensure that we avoid medications that can cause osteoporosis. Denosumab is often used as a potential alternative in osteoporosis management for those that cannot tolerate bisphosphonates. We need to monitor calcium levels when using denosumab as levels can be dangerously low, especially when used in combination with other calcium lowering drugs. Loop diuretics and cinacalcet can have additive hypocalcemia effects when used in combination with denosumab.

Der Klinisch Relevant Podcast liefert Ärztinnen und Ärzten sowie Angehörigen der Pflegeberufe und medizinischer Fachberufe wie Physiotherapie, Ergotherapie und Logopädie kostenlose und unabhängige medizinische Fortbildungsinhalte, die Du jederzeit und überall anhören kannst.

The Journal of Rheumatology's Editor-in-Chief Earl Silverman discusses this month's selection of articles that are most relevant to the clinical rheumatologist. Included is an excerpt from this month's Editor's Picks spotlight interview with authors Lisandro Colantonio, Kenneth Saag, and Marguerite Ryan Irvin from the Department of Epidemiology, Department of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA about their and their co-authors' article "Higher Serum Urate Levels Are Associated With an Increased Risk for Sudden Cardiac Death". - https://doi.org/10.3899/jrheum.210139 This month's selections also include: Ochi, et al: Similarity of Response to Biologics Between Elderly-onset Rheumatoid Arthritis (EORA) and Non-EORA Elderly Patients: From the FIRST Registry- https://doi.org/10.3899/jrheum.201135 Tanaka, et al: Effects of Denosumab in Japanese Patients With Rheumatoid Arthritis Treated With Conventional Antirheumatic Drugs: 36-month Extension of a Phase III Study - https://doi.org/10.3899/jrheum.201376 Ye, et al: Measuring Physical Function in Psoriatic Arthritis: Comparing the Multidimensional Health Assessment Questionnaire to the Health Assessment Questionnaire–Disability Index - https://doi.org/10.3899/jrheum.200927 Concha, et al: Changes in Treatments and Outcomes After Implementation of a National Universal Access Program for Juvenile Idiopathic Arthritis - https://doi.org/10.3899/jrheum.210011 Meara et al: A Case of Chilblains-like Lesions Post SARS-CoV-2 Vaccine? - https://doi.org/10.3899/jrheum.210226 Liu: Serum Uric Acid: A Murderer or Bystander for Cardiac-related Mortality? - https://doi.org/10.3899/jrheum.210695 Berard and Batthish: Addressing Healthcare Quality in Juvenile Idiopathic Arthritis With a Universal Access Program - https://doi.org/10.3899/jrheum.210658 To read these, and other full articles visit www.jrheum.org. Music by David Hilowitz

Expert: Michael Gnant, Comprehensive Cancer Center Vienna, Vienna, Austria Questions: 1.What is the recommendation for use of bisphosphonates in eBC? Which agents? How long? To which patients? 2.What is the benefit of adjuvant bisphosphonates in eBC (breast cancer - related outcomes and other benefit)? 3.What is the recommendation for use of denosumab in eBC? 4.What are the data to support these recommendations for practice?

(Club de Revista 052) En este club de revista comentamos sobre artículo que reporta el efecto a tres años de una dosis de ácido zoledrónico en la densidad mineral ósea y marcadores de recambio óseo luego de la suspensión de denosumab en mujeres con osteoporosis postmenopáusica. ENLACE: https://bit.ly/3rvbIVF

First join author Marc Dweck and Associate Editor Victoria Delgado as they discuss the article "Effect of Denosumab or Alendronic Acid on the Progression of Aortic Stenosis: A Double-Blind Randomized Controlled Trial." Then, join authors Torbjørn Omland and Geeta Gulati as they discuss the article "Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy (PRADA) Extended Follow-Up of a 2×2 Factorial, Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Candesartan and Metoprolol." Dr. Carolyn Lam: Welcome to Circulation On The Run. Your weekly podcast summary and backstage pass to the journal and its editors. We're your co-hosts. I'm Dr. Carolyn Lam Associate Editor from the National Heart Center and Duke National University of Singapore. Dr. Greg Hundley: I'm Dr. Greg Hundley, Associate Editor, Director of the Pauley Heart Center, VCU Health in Richmond, Virginia. Dr. Carolyn Lam: Hooray, it's another double feature week! And guess what, these two papers are two randomized control trials. One looking at progression of aortic stenosis and the other, looking at a prevention of cardiac dysfunction following adjuvant breast cancer therapies. Dr. Carolyn Lam: So, very interesting two papers coming right up. But Greg, why don't you start by highlighting some of your favorite papers from today's issue. Dr. Greg Hundley: You bet Carolyn. Dr. Greg Hundley: So my first study was conducted by Dr. Gabriela Trifan and colleagues from University of Illinois who performed a meta analysis of major studies that compare the efficacy and safety of dual anti-platelet therapy versus monotherapy for secondary prevention of recurrent stroke or transient ischemic attack in those previously experiencing minor non cardioembolic stroke. And their primary outcomes were stroke and the composite of stroke, TIA, acute coronary syndrome and death of all cause. And the safety outcome was major hemorrhage. Dr. Carolyn Lam: Oh, okay. Very important study. What did they find? Dr. Greg Hundley: Right Carolyn. So the analysis included 27,358 patients. And compared with monotherapy, dual anti-platelet therapy reduced the risk of recurrent stroke and the composite outcome, but increased the risk of major bleeding. And in subgroup analysis at less than or equal to 30 days, dual anti-platelet therapy increased the risk of hemorrhage relative to monotherapy. In sensitivity analyses, the risk for hemorrhage with less than or equal to 30 days of dual anti-platelet therapy, after excluding the combination of aspirin plus Ticagrelor, was comparable to monotherapy. However, the risk of stroke recurrence and composite outcomes in the subgroup and sensitivity analyses remained decreased compared to monotherapy. Dr. Greg Hundley: And so Carolyn, the take-home message from this paper is that dual anti-platelet therapy decreases the risk of recurrent stroke and composite events compared with monotherapy. But, dual anti-platelet therapy increases the risk of major hemorrhage, except if the treatment is limited to 30 days and does not include the combination of aspirin plus Ticagrelor. Dr. Carolyn Lam: Ah, thanks for that last take home message. Thank you. Dr. Carolyn Lam: Well, the paper I'm going to tell you about is the first to examine the role of epicardial fat derived extracellular vesicles in the pathogenesis of atrial fibrillation. And this comes from Dr. Leor from Sheba Medical Center, Tel Aviv University in Israel and his colleagues who collected epicardial fat specimens from patients with and without atrial fibrillation during elective heart surgery. Dr. Carolyn Lam: Epicardial fat samples were grown as organ cultures and the culture medium was collected every two days. And the authors then isolated and purify these epicardial fat extracellular vesicles from the culture medium. Dr. Carolyn Lam: They found that epicardial fat extracellular vesicles of patients with atrial fibrillation had unique pro-inflammatory, profibrotic and proarrhythmic properties. Epicardial fat extracellular vesicles could in fact induce cellular, molecular and electrophysiological remodeling that could result in atrial fibrosis, myopathy and the development of atrial fibrillation. Dr. Greg Hundley: Wow Carolyn, so what are the clinical implications of epicardial fat extracellular vesicles? Dr. Carolyn Lam: Hmm, good question. Well, understanding their role in the pathogenesis of atrial fibrillation may for one lead to the discovery of new diagnostic markers or new targets for the prevention and treatment of atrial fibrillation. And that combined pro-inflammatory profibrotic and proarrhythmic effects of these epicardial fat and extracellular vesicles may in fact be relevant to the pathogenesis of other cardiovascular diseases associated with obesity and abnormal adipose tissue deposition. Dr. Greg Hundley: Very nice Carolyn. Dr. Greg Hundley: My next paper comes again to us from the world of preclinical science and these authors led by Dr. Masanori Aikawa from Harvard Medical School applied a systems approach in mouse experiments to discovering therapeutic targets for vein graft failure. They use global proteomics and high dimensional clustering on multiple vein graft tissues to identify potential pathogenic mechanisms. And experiments were conducted in both in vivo mouse models and in vitro human macrophages. Dr. Carolyn Lam: Oh wow. So what did they find? Dr. Greg Hundley: So Carolyn, peroxisomes proliferator activated receptors or PPAR alpha agonism by pemafibrate retarded the development and inflammation of vein graft lesions in mice, while gene silencing worsened plaque formation. Pemafibrate also suppressed arteriovenous fistula lesion development. Dr. Greg Hundley: Now, metabolomics, lipidomics, functional metabolic assays and single cell analysis of cultured human macrophages revealed that PPAR alpha modulates macrophage glycolosis, citrate metabolism, mitochondrial membrane sphingolipid metabolism and heterogeneity. Dr. Carolyn Lam: Okay. So what is the take home message Greg? Dr. Greg Hundley: Right Carolyn, thought you would ask me that. Dr. Greg Hundley: So PPAR alpha activation suppresses the development of vein graft and arterial venous fistula lesions. And PPAR alpha reduces macrophage activation by influencing macrophage heterogeneity, mitochondrial integrity, and the metabolome. So Carolyn, given that peripheral arterial disease and chronic kidney disease prevalences are increasing, warranting needs for more vein grafts and arterial venous fistulas, this target discovery platform is applicable to investigating therapies for these diseases. Dr. Greg Hundley: And a really nice accompanying editorial is provided by doctors Reilly and Bornfeldt. Dr. Greg Hundley: Well Carolyn, how about we turn to look at what is in the mailbag this week? Dr. Carolyn Lam: Well let me tell you about it Greg. We've got a cardiovascular case series by Dr. Borlaug on things are not always as they seem, multimodality exercise assessment and evaluation of dyspnea. In cardiology news by Kuhn there's a discussion of Evinecumab approval adds a new option for homozygous familial hypercholesterolemia with a hefty price tag. A perspective piece by Dr. Watkins on time to think differently about sarcomere negative hypertrophic cardiomyopathy. And finally a research letter by Dr. Ahn on reduction in Kawasaki disease after non-pharmaceutical interventions in the COVID-19 era, a nationwide observational study in Korea. Dr. Carolyn Lam: Wow. That wraps it up for the summaries. Let's go on to the feature discussions shall we, Greg? Dr. Greg Hundley: You bet. Dr. Carolyn Lam: We are about to talk about the extended follow-up results of the PRADA trial. Oh, so interesting. So happy to have with us today, doctors Geeta Gulati and Dr. Torbjørn Omland, both from the Akershus University hospital in Norway, and you would probably recognize that Dr. Torbjørn Omland is also one of our associate editors, but both here are the co-corresponding authors of this beautiful paper. Dr. Carolyn Lam: Thank you so much for coming here today. Torbjørn, maybe you could start with what is the PRADA trial? Why did you decide to do an extended follow-up? Dr. Torbjørn Omland: Yeah so PRADA was a two times two factorial randomized double blind clinical trial that sought to evaluate the effects of intervention with receptor blocker Candesartan. And a beta blocker Metoprolol in patients with early breast cancer who received anthracycline therapy as part of their chemotherapy. And then we wanted to assess the effect of this sort of preventative therapy, left ventricular function and injury. Dr. Torbjørn Omland: So we reported the primary results of the trial a few years ago and showed that intervention with Candesartan most associated with a significant elevation of the reduction in left ventricular ejection fraction that these patients may experience, and also that treatment with the beta blocker Metoprolol was associated with an intimation of the increase in cardio proponents suggesting a beneficial effect on myocardial injury. However, whether these results were or these effects were sustained after termination of the study drugs was unknown. And that was what we really wanted to address with extended follow-up study. Dr. Carolyn Lam: Yeah, makes a lot of sense, especially because these injuries I suppose could still continue. And just to be very clear, the medications though were only taken during the adjuvant chemotherapy and therefore could be a variable duration from what I understand. Right? Great. Dr. Carolyn Lam: So Geeta then, could you tell us what did the extended analysis show? Dr. Geeta Gulati: The extended follow-up was interesting and it was something we really wanted to figure out because there are not many studies who have been done on the extended follow-up and you're not giving these study medications afterwards. Dr. Geeta Gulati: So very interestingly we saw that the decline in the ejection fraction was still there in the whole group. But this time there was no difference in the group who received Candesartan do those who didn't. And we show that there was a different in the primary results, but now in the extended follow-up there was no difference. And then also in the Metoprolol group that had previously shown that there was lesser rise in the troponins. Again, there was no difference in the groups now on the extended follow-up. Dr. Geeta Gulati: So this is very interesting because this shows that there is a small, modest decline in a left ventricular ejection fraction during and after the breast cancer therapy. But what does this really mean? It's a small decline and it's within the normal range and the cardioprotection is not working. So, are we perhaps looking at the wrong group? Perhaps we should look at patients who have the higher cardiovascular risk factors. Perhaps even we should look at more novel heart failure or cardiac drugs that may have a stronger effect on the ejection fraction. Dr. Carolyn Lam: Right. So Geeta though, can we unpack that a little bit? You see, the patients were not on the medication anymore at the time of follow-up. So you're saying that even though they were given adjuvant chemotherapy and covered with the drug, that even not having any more chemotherapy, their ejection fraction still fell. And if I'm not wrong, this was an MRI analysis. And so it was only by an ejection fraction of two percent on mean fall, right? How do we think about that clinically? Dr. Geeta Gulati: And that's the important question, isn't it? Because a decline in the ejection fraction of less than two percent within the normal range, what does it really mean? Well initially we thought that if there was a different in those who had cardioprotective medication compared to those that didn't, it may prevent development of further decline in the cardiac function and then heart failure in the future. But now, there is really no difference between the groups. So perhaps the clinical implication of giving cardio protection to all cancer patients is not really that useful. Perhaps they should look at those who are at higher risk because they would have a greater fall in ejection fraction and then more cardioprotective effect of these drugs. Dr. Carolyn Lam: Yeah, totally. And perhaps the metrics that we're used to seeing in the past with greater falls of ejection fraction, maybe it just doesn't apply currently or perhaps with the specific chemotherapeutic regimens perhaps that you're using now. Because with a very small fall, and I believe you only had one heart failure event, right? If I'm not wrong in this extended follow-up. So, just to let the audience know, it was very small fall, little number of events. It's hard to really tease apart what that clinically means. Now, could I ask though, does it mean we need actually a more sensitive marker? Because there was some interesting stuff about global longitudinal strain. Could you- Dr. Geeta Gulati: I would throw that question back to Torbjørn I think. Dr. Torbjørn Omland: Yes. So that's a very interesting question Carolyn. So we did observe what seemed to be a beneficial, but a sort of minor effect on global longitudinal strain. So we know that that is the more sensitive index of systolic function than left ventricular ejection fraction, that was the pre defined primary outcome. So that's raises of course questions whether a future trial should more focus on these more sensitive indices of cardiac function. Dr. Carolyn Lam: Yeah. Geeta, could I then really put it back to you? And the tough question I always get, how do we apply these results clinically then? I mean, you see these patients right? Now what? Do you give or do you don't give? And which one do you give? And how do you identify high risk patients? I don't know. Dr. Geeta Gulati: Again, I think all the patients are unique aren't they? So that's where we have to start. So in my clinic, if I have a high risk patient with hypertension, diabetes, hypercholesterolemia, yeah perhaps they even have had a cardiovascular disease before something like this. Then I will take more care of these patients and be more careful with the echo measurements I'm doing and if I find that they have a decline in their cardiac function, I may be more eager to start them on cardioprotective medication. Dr. Geeta Gulati: But then in R-Regen we follow all the HER two positive breast cancers with echo. If I don't have echoparamaties that clearly tells me that they have a decline in the cardiac function, then I may wait to start cardio protection because none of the studies has really so far show that all patients should have these cardioprotective medication or prevention. Dr. Carolyn Lam: Nice. Thank you. That was a tough one to get at. And I suppose Torbjørn I have to give you another tough one then. Because how to address the remaining unanswered questions, right? Because one of them on my mind too, is how to identify the high risk, do biomarkers play a role? And then the other is if we then start the preventive therapies like ERBs and beta blockers, should we actually continue it forever? And so on. But anyway Torbjørn please, please, what does the future hold? Dr. Torbjørn Omland: I think it's worthy of a recap or underscoring that these are really good news for many breast cancer patients that actually the risk of an important decline in ventricular function is lower than we thought. So that may be because of several things. I think in general, those whose used these cardiotoxic drugs are lower. And we also, I think that there's increased collaboration between oncologists and cardiologists. Also meaning that we are better to pick up the high-risk patients at an early stage. Dr. Torbjørn Omland: But of course, it's very important questions that you asked regarding how to identify the high risk patients. And I think that's where really future research should focus. So there we know that traditional risk factors are important. We are looking into whether biomarkers can be used, if there's more sensitive imaging in this can be used. But so far we haven't really succeeded in getting the risk model that really identifies it on the patient level. So that's work that remains to be done. Dr. Torbjørn Omland: And then we are also looking for new types of intervention, good exercise, good other drugs. We are doing now a PRADA two study where we look at the effects of Sacubitril Valsartan in this setting. And those are also very exciting, I think, and we look very much forward to present that in the future. Dr. Carolyn Lam: Oh wow thank you so much Torbjørn and Geeta. The PRADA two trial. I've got to ask you, why do you then call it the Chanel trial? But I think I'll save that for another day. So thank you. Thank you once again, this is fabulous and congratulations to you both. Dr. Torbjørn Omland: Thank you. Dr. Geeta Gulati: Thank you. Dr. Greg Hundley: Well listeners, welcome to our second feature discussion today. And we have with us Dr. Marc Dweck from University of Edinburgh in Scotland and our own associate editor, Victoria Delgado from Leiden in the Netherlands. Welcome to both of you. Dr. Greg Hundley: Marc, we're going to get started with you. Could you tell us a little bit about the background for your study and what was the hypothesis that you wanted to test? Dr. Marc Dweck: Thanks very much Greg for the invitation. So I guess aortic stenosis is perhaps the last major cardiovascular condition where we don't have a medical therapy. We're unable to treat these patients. We're unable to prevent progression. We're only left with a valve replacement. And so we, like a lot of groups around the world, want to develop a treatment for aortic stenosis. Our group did the first SALTIRE trial, where we looked at statins seeing if we could slow aortic stenosis progression. And that, like similar trials, was neutral. No effect on the valve progression. Dr. Marc Dweck: And so actually I've spent the last 10 years looking at some of the factors associated with aortic stenosis progression in particular. The answers that we've had from those trials have kind of come back telling us that really it's a process of calcification. If you look at what triggers progressive valve narrowness is this calcific process, that seems to be a self perpetuating disease. Dr. Marc Dweck: So the question is, how do you target this calcification process? How can you interrupt it? And how can you do that without compromising bone health in these elderly patients? So in trying to come up with a solution to that we thought about using osteopetrosis agents, which we hypothesized would maintain both bone health and reduce vascular calcification on the basis of observational data and also animal data suggesting that. And that was really where we came from in the design of the SALTIRE two trial. Dr. Marc Dweck: And doing a big trial with clinical endpoints wasn't felt to be feasible and instead we decided to look at imaging end points and see whether we could slow disease progression using these agents. Dr. Greg Hundley: Very nice Marc. And so you're really leading us into, tell us a little bit more about your study population and your study design. Dr. Marc Dweck: Yeah so we wanted to take patients from our outpatient clinic with mild, moderate and even early severe disease, asymptomatic patients crucially, patients that aren't scheduled for aortic valve replacement and see the effects of these drugs on disease progression. Dr. Marc Dweck: So we did a randomized control trial. There was three arms. Patients were randomized to Alendronate, Denosumab, these are the two osteopetrosis agents, or placebo. We then did a series of baseline imaging tests. So the primary end point was based on CT calcium scoring. So they had a baseline CT calcium score. They also had a baseline echocardiogram and they had a baseline fluoride PET scan. So this measures calcification activity in the valve. And then we essentially repeated those tests after a period of time on the drugs, or on placebo. We repeated the calcium score and the echo after two years and repeated the PET scan after one year. Dr. Greg Hundley: Very nice, and so before you tell us your results, a little bit, how many patients? And maybe their average age and the rough distribution of men versus women. Dr. Marc Dweck: Yeah so study recruited roughly 50 patients in each arm. The average age was 72 and there was 21% females in the study. So, like a lot of studies in aortic stenosis, a low female prevalence. Despite our best efforts, that's something we need to attend to in the future, but otherwise, a representative age group and patients with this disease. Dr. Greg Hundley: And what did you find? Dr. Marc Dweck: Well we found that the drugs didn't have an effect on any of these imaging assessments. So, there was no effect on the progression for CT calcium score at two years, no effects on any of the echocardiographic assessments of hemodynamic severity, and no effect on calcification activity as measured with the fluoride. Dr. Marc Dweck: So a very consistent result using multiple different imaging modalities, which I think gives us confidence that there isn't at least a dramatic effect of these drugs on disease activity or disease progression, in aortic stenosis. Dr. Greg Hundley: Very good. Well listeners, we're now going to turn to one of our associate editors, Dr. Victoria Delgado, and she is really a valvular heart disease expert member of our team. Dr. Greg Hundley: Victoria, I know you see a lot of papers that kind of come across your desk. What attracted you to this manuscript? And then how do you put the results in the context of other research that's going on to halt the progression of aortic stenosis. Dr. Victoria Delgado: Thank you Greg. So first the first thing that attracted my attention for this article is the question. We know that we don't have any medical therapy for halting the progression of aortic stenosis. And even if the previous studies have been negative or neutral, still there is the interest of trying to find a less invasive therapy for these patients, or even prevent that they arrive to surgical or transcatheter aortic valve replacement. Dr. Victoria Delgado: And the second is that these are very strong analysis because it's a randomized clinical trial and using as end points imaging. So that trial also in a way answers the question of which imaging technique we need to use in order to see the effects of specific therapies. Previous studies have used mainly echocardiography, but that only gave us information on the modynamic effects of the aortic stenosis. While in this study, we have the combination of CT and a combination of a PET that he give us also information on how the calcification is happening. So that makes the study very comprehensive and give us more insights into this pathophysiology, to this pathology particularly. Dr. Greg Hundley: Very nice. So it sounds like looking at aortic stenosis from multiple different angles, whether it be echocardiography or perhaps imaging processes that look at the progression of calcification. Dr. Greg Hundley: Well, Marc, I want to come back to you. What do you think is the next, sounds like you've been working in this area for an extended period of time. What do you see as the next research study that you and your group may undertake in this area? Dr. Marc Dweck: I Think we've got the study design about right. I think if in the future studies we want to do, I think we would adopt a similar design using these imaging end points. Dr. Marc Dweck: I have to say I'm very influenced by the recovery trial that has been conducted in the UK with COVID. I mean, here's a disease where we wanted to get a treatment as quickly as we can. And in doing that, developing a platform type trial where you potentially test multiple different promising agents simultaneously across multiple centers across the world or the UK, I think that would be the quickest way to developing a treatment. And so I'm encouraged that there are five or six very good targets where we could, for a new therapy in aortic stenosis. And I think a platform type design where we engage multiple groups using imaging as that initial end point. And then, the drugs that appear to have an effect on these imaging end points we can start to recruit more patients at those sites, into those centers, looking for clinical end points. Dr. Marc Dweck: I think that kind of discussion is happening around the world now between groups that are interested because we want to crack this problem quickly. We don't want to wait and do these different studies sequentially. We want to try and do them simultaneously. And I'm excited about that. I think if we do that, we've got a real shot at developing a treatment over the next five to 10 years say. Dr. Greg Hundley: Fantastic. Dr. Greg Hundley: And Victoria, I know you have interest in this particular area. Do you have anything you'd like to add? Dr. Victoria Delgado: Yeah. I think that those studies that Mark said are really welcome and I hope that they are positive. And give us a little bit of more to treat these patients. My main fear is that these patients are not as frequent, for example, as heart failure patients. Where we have several therapies where we have possibility to enroll patients in trials for new drugs, that we know that probably are going to be effective. But for valvular heart disease it has been always the end point to reach surgery or to reach an aortic valve replacement or indication of the mitral valve and mitral valve repair. So in early phase of the disease, my main concern is that maybe the patient is not going to be well-trained to understand what are the consequences. I want to always wait until maybe when is needed for the surgical or transcatheter procedure. Dr. Victoria Delgado: But I think that increasing the awareness of the prevalence of valvular heart disease and the consequences may help people to understand, to put more attention for an early diagnosis and develop new drugs that can help, like in this case, aortic stenosis one of the most frequent valvular heart disease, to prevent the proliferation and to prevent the replacement of the valve. Dr. Greg Hundley: Very nice. Well listeners, this has been a wonderful discussion and we greatly appreciate the input that we've been able to gather today from Dr. Marc Dweck from Edinburgh in Scotland and our own associate editor, Dr. Victoria Delgado. Bringing this information from a randomized trial, evaluating osteoporosis drugs, and really indicating they did not disrupt the progression of calcification in patients with aortic stenosis. Dr. Greg Hundley: Well, on behalf of Carolyn and myself, we want to wish you a great rest of your week and we will catch you next week on The Run. Dr. Greg Hundley: This program is copyright of the American Heart Association, 2021. The opinions expressed by speakers in this podcast are their own and not necessarily those of the editors or of the American Heart Association. For more, visit ahajournals.org.  

In episode 473, Mike and James invite Samantha Moe yet again to talk about a recent Tools for Practice that looked at treatments for osteoporosis. Sam helps us put all the evidence into perspective for bisphosphonates and denosumab when it comes to fractures. We discuss the numbers and help explain why secondary prevention in osteoporosis is not really secondary prevention.

Cousin's Raylee and Lisa are the first Australian participants in the ground-breaking BRCA-P clinical trial. The BRCA-P trial is a prevention trial which is testing the effectiveness of a drug called Denosumab in preventing breast cancer in women with a BRCA1 gene mutation, like Lisa and Raylee. This treatment has been fast tracked from the lab to a stage three clinical trial due to it's impressive pre-clinical results. Listen in as Lisa and Raylee tell us what it's like to know you have a 70% risk of being diagnosed with breast cancer due to the BRCA1 gene mutation, what it's been like participating in the BRCA-P clinical trial and what their children think about their 50/50 chance of having the BRCA1 gene mutation. To find out more about the BRCA-P clinical trial visit www.breastolution.com.auTo find out more about our life-saving research, or to support our research visit www.breastcancertrials.org.au

(Club de Revista 021) En el club de revista de hoy comentaremos artículo sobre terapia secuencial con ácido zoledrónico luego de denosumab en osteoporosis. ENLACE: https://bit.ly/321apT9

Osteoporosis is very common among the elderly. In this episode, Nhan & Ishaan discuss all things osteoporosis.If you like this episode, be sure to subscribe and leave us a review on iTunes!!https://podcasts.apple.com/au/podcast/breaking-the-capsule/id1479407995Follow us on Facebook and Instagram:https://www.facebook.com/Breaking-the-Capsule-110257606996674/https://www.instagram.com/breakthecap/?hl=enEmail us at contact@breakingthecapsule.com with any questions

HOPA Now is the official podcast of the Hematology/Oncology/Pharmacy Association, an organization dedicated to supporting pharmacy practitioners and promoting the advancement of Hematology/Oncology/Pharmacy to optimize the care of individuals impacted by cancer.   These educational podcasts are part of our BCOP Preparatory and Recertification Course, which is designed to prepare oncology pharmacists preparing to sit for the BCOP Certification Exam, as well as meet the BPS requirement to complete a BCOP Preparatory/Recertification Review Course.   In this episode of HOPA Now, Dr. Bernard Marini highlights the main clinical pearls of adult acute leukemias and myelodysplastic syndrome, including unique factors that affect dosing, drug monitoring factors, and guidelines, and the oncologic stewardship and dosing caps for various drug usage.   In this episode you will learn:   Adult Acute Leukemias & Myelodysplastic Syndrome: Top 10 Clinical Pearls There are unique lenalidomide sensitivities for patients with deletion 5q. Thrombopoietin mimetics and growth factors for patients with MDS Guidelines for use of potent ASAL antifungals Denosumab azomycin and oncologic stewardship and dosing caps Secondary AML and oncologic stewardship outcomes and alternatives Characteristics and management of IDH inhibitors and differentiation syndrome Asparaginase and therapeutic drug monitoring and a comparison of adult versus pediatric patients reactions and survival rates Blinatumomab and inotuzumab use and outcomes in patients with less disease burden Balancing safety and efficacy of TKIs in patients with ph positive ALL   Mentioned in This Episode: HOPA   Quotes:   “Patients with deletion 5q are uniquely sensitive to lenalidomide.” — Dr. Bernard Marini   “Given the flaws in the alpha trial and the meta-analysis, this is potentially a place for oncologic stewardship in avoidance in risk in a drug with no overall survival benefit.” — Dr. Bernard Marini   “IDH inhibitors in AML are fascinating agents.” — Dr. Bernard Marini   “Adults and young adult patients have significantly worse survival rates compared to pediatric ALL counterparts.” — Dr. Bernard Marini  

Dr. Ebell and Dr. Wilkes discuss the POEM titled ' Denosumab no better than bisphosphonates at preventing fracture, and the cost is much higher '

Dr. Barry Gruber explains why you cannot space Denosumab treatments

What are the cardiac implications of COVID-19? Find out about this and more in today's PV Roundup podcast.

(Cápsula 20) Las fracturas asociadas a osteoporosis son sub-tratadas en parte por falta de información sobre las recomendaciones de manejo y en parte por diferencias entre las diferentes guías de tratamiento. ENLACE: https://asbmr.onlinelibrary.wiley.com/doi/abs/10.1002/jbmr.3877

An interview with Dr. Charles Shapiro from Mount Sinai Hospital in New York and Dr. Joan Neuner from Medical College of Wisconsin, co-chairs of "Management of Osteoporosis in Survivors of Adult Cancers with Nonmetastatic Disease: ASCO Clinical Practice Guideline." This guideline includes recommendations on assessing risk factors and interventions, including pharmacologic and nonpharmacologic options. Read the full guideline at www.asco.org/survivorship-guidelines TRANSCRIPT Hi. My name is Clifford Hudis, and I am the CEO of the American Society of Clinical Oncology as well as the host of the ASCO in Action podcast. About twice a month, I interview thought leaders in healthcare care and experts in oncology, and we provide analysis and commentary on a wide range of cancer policy and practice issues. You can find the ASCO in Action podcast on Apple podcasts or wherever you are listening to this show, and you can find all nine of ASCO's podcasts, which cover a wide range of educational and scientific content, and offer enriching insight into the world of cancer care at podcast.asco.org. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello and welcome to the ASCO Guidelines Podcast series, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. My name is Shannon McKernin and today on the ASCO Guidelines Podcast, I'm interviewing Dr. Charles Shapiro from Mount Sinai Hospital in New York, and Dr. Joan Neuner from the Medical College of Wisconsin, Milwaukee, co-chairs of management of osteoporosis in survivors of adult cancers with non-metastatic disease ASCO clinical practice guideline. Thank you for being here, Dr. Shapiro and Dr. Neuner. Thanks a lot. Pleasure to be here. So first, can you give us a general overview of what this guideline does cover? This guideline covers very important topics, that of osteoporosis and that of cancer survivorship. It's the coalescence of these two common problems that is the impetus for this guideline. It covers risk factors and what you can do as a cancer survivor to mitigate your risk. It covers screening and identification of the best test to use to measure your bone density, and it covers how to treat or pull the trigger for anti-osteoporosis drugs based on the guidelines that are contained within the document. And what are the key recommendations for this guideline? So we developed this guideline with three key guideline questions in mind. And they really required a fairly extensive search of the literature to address them. And we did that by looking to some of the literature outside of cancer in osteoporosis screening in other patients as well. So I'll sort of talk about it in terms of the three key questions. So the first question we had was, which patients with non-metastatic cancer are at increased risk for developing osteoporotic fractures? So that first question was, which patients are we really addressing in this guideline? And how do we assess whether they're at potentially increased risk? So in response to that, we strongly recommend that oncologists teaming with other physicians, including primary care doctors like myself, evaluate their patients to determine whether they're high risk. And so we provide a lot of details in an extensive document. But in our bottom line, we have a summary of the most common and the most severe risk factors. And those include things like advanced age, current smoking, excessive alcohol consumption, and a history of prior fractures, so already showing that they're at high risk for fractures. So we recommend you look to that list. And then add in your own clinical judgment, particularly about patients who have added risks from their cancer treatments. And so we do also talk about those patients. And in particular, we call out patients with specific anticancer therapies, for example, aromatase inhibitors given to breast cancer patients, antiandrogens or GnRH agonists given to breast cancer and prostate cancer patients and call out how they're at particular risk. And finally, in response to this question, we also recommend that you consider using a risk assessment tool. And here, I mention that we had to look to the non-cancer literature. So here, the WHO actually developed something called the Fracture Risk Assessment Tool, or FRAX. And we do recommend that you use this tool or something like it to help you to assess whether your patient is at high risk. And those are readily available on the web. Search FRAX-- F-R-A-X-- to use it. And, of course, we have links in the guideline. So that addresses the first question, which again was, which patients are at increased risk? And we have a list of risk factors that you should be considering and some references, particularly FRAX, to help you with thinking about those risk factors and how important any specific risk factor is. Our second question really dovetailed right on that. And that was, how should patients who are at increased risk, you've identified as part of that first question, to be at increased risk for osteoporotic fractures be screened? And here again, we look to the standard recommendations for patients who don't have cancer as well. And there are two ways that you could move towards, should you screen your patient or not? One could be your patient had one of those risk factors that we talked about and are listed in the document. The other is you use that FRAX tool and patients are more than average risk. And then we recommend patients be screened using one of the standard screening tools. The most common one, is called dual X-ray absorptiometry. And I want to specifically mention central dual X-ray absorptiometry, which means that the test is done on the hip and the lumbar spine. Those are readily available. All major medical centers have them, and many clinics have them as well. And so we do recommend that for screening. And then we offer some specifics about how frequently you might screen, because that's another question that often comes up. And so then our final question is once you determine that your patient is at high risk because their bone density test and/or their FRAX test shows that patients are at high risk, we do encourage talking to them about treatment options. And the first thing I want to say is essentially everyone that our guideline addresses, which is all patients who currently have or who are survivors of non-metastatic cancer, that they should consume a diet with adequate calcium and vitamin D. And so that's generally considered to be 1,000 to 1,200 milligrams of calcium and at least 800 to 1,000 IUs, international units, of vitamin D. We also strongly recommend exercises and call out some specifics. That you want to work on balance, flexibility, and resistance, if possible. And that you quit smoking and limit alcohol consumption. All very good things for the body generally, but also very good for the bones. Obviously, the meat of this guideline is also about pharmacologic intervention specifically. And since Dr. Shapiro treats so many patients with this, I'm going to ask him if he wants to comment further on specifics about pharmacologic treatments, when you think patients should get them. So thanks, Joan. So pharmacologic interventions include RANK ligand inhibitors, like Denosumab or IV or oral bisphosphonates. So clearly, if your patients are at risk, that means a hip fracture predicted at 3% or more or a non-hip vertebral fracture at 20% or more-- and you get these numbers from the FRAX calculator and other calculators in common usage-- then you pull the trigger and use one of these agents. Now we couldn't distinguish between the agents in terms of what's one was preferred. It depends on patient preference, comfort with the doctor in terms of how comfortable the doctor is using the agent, and other factors that go into the decision about which biphosphonate to use. Generally, the IV Zoledronic Acid and sub-cu Denosumab are used in the cancer populations. But oral biphosphonates can be used as well. And why is this guideline so important? And how will it change practice? Well, this guideline is so important because we know from survey studies that osteoporosis and preventing osteoporosis and treating osteoporosis in the cancer survivor population is underutilized. And this is an important point, because many people, especially with breast and prostate cancer and colorectal cancer and bone marrow transplants, will be long-term survivors. And we don't want to cure a patient just to have them fracture 10 or 20 years later. So that's the importance of the guideline. So it's the recognition that osteoporosis is treated the same, whether you're a cancer survivor or not. But the cancer treatments we use in routine practice can cause osteoporosis and bone loss. And that's the importance of this recommendation, as well as the particulars of who's at risk, the risk factors, screening, and pulling the trigger for treatment. So that's basically in a nutshell, why this guideline is so important and how it will change practice, because we hope that the guideline stimulates us, as health practitioners, to screen our patients for osteoporosis, recognize risk factors, and how to pull the trigger on treatment to prevent or treat osteoporosis in this population. It doesn't matter who follows patient, but the patient has to know who's going to follow the bone density and treatment for osteoporosis, whether it's comfort that an oncologist has with the whole process of screening and risk factors and pulling the trigger for bisphosphonates or Denosumab or endocrinologists, the rheumatologist, the primary care physician. The patient's got to know who's going to be responsible for what aspects of care, survivorship care. And this is a big part of survivorship care. So the treatment summary, which is a document that the patients get and is given to the primary care provider, should specify who will take responsibility for what aspects of survivorship care. And this is a big aspect of survivorship care, osteoporosis screening and treatment, if necessary. So it doesn't matter who does it, as long as it gets done. I would jumped in if I could, Charlie. Yes, so please jump in. So I guess the only other point that I wanted to make about how it might change practice is osteoporosis guidelines have been out since the late '90s, early 2000s. And so many patients probably have thought about osteoporosis and their risk in the past. But I did want to note that there have been a number of studies in the last five years showing that in primary care-- so family medicine and general internal medicine, like I practice-- that we're actually ordering fewer bone densities than we did in the past. And all the reasons for that aren't clear. Perhaps it's because of some concerns about the rare side effects of some of these medicines. Perhaps it's because the guidelines aren't clear because the data is not clear about how often we should test people who don't seem to be at high risk once they've had a first test. But nonetheless, there seems to already be some effects of this that the hip fractures, which had been decreasing are starting to look like they're rising again. So it really is important then if we're not going to screen very frequently everybody, that we are screening the people who really need it. And so then this guideline it calls that out that these are patients who because either their cancer treatment and the debilitating nature of that in some cases or the specific medications puts them at particular risk. Those are the ones that we can't omit this. Great. Finally, how will these guideline recommendations affect patients? You know, I think we're hoping that this will help in the care of cancer survivors and spark people to use things like survivorship care plans. Or if those don't work in your institution, other ways to make clear what the patients who are survivors are at risk for, both related to their cancer and outside their cancer, so that we can all work as teams of health care providers to make sure all of the things on those lists addressed. So we're hoping that with some very clear recommendations about how to address bone health that we can help those teams serve patients that they can. Obviously, it can also provide some really essential information for patients who are wondering what the things that need to be wondering about in this new phase of survivorship after cancer that they're dealing with. Dr. Shapiro, did you have anything to add to that question? Hopefully, we can prevent fractures in our cancer survivors by following these guidelines. It's really important that we prevent osteoporosis and hip fractures and vertebral fractures, because we don't want to cure the patient just that saddle them with osteoporosis and breaking a hip or breaking vertebral body 10 or 20 years down the line. So this will hopefully affect patients positively. And we intended the guideline to be for patients in terms of risk factors. And if you need a biphosphonate or anti-osteoporosis drug, then it's clear indications in the document who gets it and who doesn't. So I think that the effect we hope would be great on patients, that part of general health is osteoporosis screening. And just because you're a cancer patient doesn't absolve you from participating in all the health recommendations, including osteoporosis screening. As with all ASCO Survivorship Guidelines, we do hope that this one informs many conversations between patients, survivors, and providers. Thanks to your overview here today and your work on this guideline, more clinicians will be informed of the risk factors and possible interventions for osteoporosis and survivors of non-metastatic cancers. So I want to thank you both for coming on the podcast to discuss this guideline with me today. Thanks for having us. Yes, thank you. And thank you to all of our listeners for tuning into the ASCO Guidelines Podcast series. To read the full guideline, go to www.asco.org/survivorship-guidelines. And if you've enjoyed what you've heard today, please rate and review the podcast. And be sure to subscribe, so you never miss an episode.

(Cápsula 016) La osteoporosis conlleva un aumento del riesgo de fractura que lleva a dolor, aumento del gasto en salud y riesgo de muerte y complicaciones por la misma fractura o el manejo que esta requiera. Por lo anterior, se deben tomar medidas para evitar caídas que puedan llevar a fracturas de fragilidad en las personas que tengan el diagnostico de esta enfermedad. A continuación daremos algunos consejos que pueden ayudar a evitar una caída que cause una fractura.Mayor información en www.reumatologia.online

Denosumab (1:30), cholesterol guidelines (4:10), drug-drug interactions (8:00), post-traumatic stress disorder (14:50), saline irrigation (17:10), and top research studies of 2018 (18:40).

Listen to Mr Sam Patton (Oncology Specialty Editor for the BJJ) interviewing Professor Ajay Puri about his paper "Neoadjuvant denosumab: its role and results in operable cases of giant cell tumour of bone" published in the February 2019 issue of The Bone and Joint Journal.Click here to read the article

Prof Gnant talks to ecancertv at ASCO 2015 about the use of adjuvant denosumab to reduce bone problems in postmenopausal women with breast cancer receiving treatment with aromatase inhibitors. Adjuvant endocrine therapy compromises bone health in patients with breast cancer, causing osteopaenia, osteoporosis, and fractures - but the addition of adjuvant denosumab to the treatment plan reduces patients' risk of clinical fractures.

Dr Raje speaks with ecancer at the 16th International Myeloma Workshop about an international, randomised, double blind trial comparing denosumab with zoledronic acid for the treatment of bone disease in patients with newly diagnosed multiple myeloma.

Prof Terpos speaks with ecancer at the 16th International Myeloma Workshop about late breaking data from IMW 2017, assessing the efficacy and safety of denosumab compared with zoledronic Acid in newly diagnosed symptomatic myeloma patients. Targeting RANKL, this Phase III study with denosumab met its primary endpoint of non-inferiority to zoledronic Acid in delaying time to first on-study skeletal related events in patients with newly diagnosed myeloma. Denosumab also showed comparable overall survival and for the first time superior PFS compared with zoledronic Acid. Renal adverse events were also greatly reduced with denosumab. These results and the fact that denosumab can be administered subcutaneously, lead to the suggestion that it will become a new standard of care for the management of bone disease in multiple myeloma.

Prof Terpos speaks with ecancer at the 16th International Myeloma Workshop about the bone related complications seen with myeloma patients (MM) and how these are managed. Approximately 80% of MM patients present with detectable lesions of osteolytic bone disease, meaning it is a critical consideration to the overall treatment and management of patients with multiple myeloma. The current management of MM bone disease is based on the use of bisphosphonates and mainly Zoledronic Acid due to favourable study results. In some patients with side effects such as renal impairments it is recommended to stop bisphosphonates, however new studies involving Denosumab suggest that a solution may be on its way.

Prof Terpos speaks with ecancer at EHA 2017 about the comparative trial of denosumab and zoledronic acid for skeletal disease in new multiple myeloma diagnoses. Prof Terpos describes how, from a randomised trial of 1718 patients, the progression to skeletal disease at 15 months was equivalent in both arms, with denosumab meeting its non-inferiority goals. Those receiving denosumab were also found to have reduced renal toxicity, and, in an exploratory assessment, progression free survival was also favourable.

Prof Gnant presents, at a press conference at SABCS 2015, results from the phase III ABCSG-18 clinical trial. The results showed that adding denosumab to adjuvant aromatase inhibitor therapy improved disease-free survival for postmenopausal patients with early-stage, hormone receptor-positive breast cancer.

Prof Gnant talks to ecancertv at SABCS 2015 about results from the phase III Austrian Breast & Colorectal Cancer Study Group (ABCSG)-18 clinical trial in which denosumab was added to adjuvant aromatase inhibitor (AI) therapy. Denosumab is a monoclonal antibody licensed for the treatment of osteoporosis, drug-induced bone loss and bone metastases. Long-term AI therapy is associated with bone loss so the rationale was to see if denosumab could prevent this. The trial included more than 3000 for postmenopausal women with early-stage, hormone receptor- positive breast cancer who were treated with AI therapy alone or with additional denosumab given as subcutaneously injected dose of 60 mg every 6 months. Data on the primary bone end points were recently published in The Lancet and showed that denosumab could halve the risk of clinical bone fractures. The disease-free survival data presented by Prof Gnant at SABCS 2015 showed that, at a median follow-up of 4 years, that this secondary end point was also substantially improved.

Dr. Benjamin Levy, Mount Sinai Health Systems, compares zoledronic acid and denosumab, two agents used for treatment of bone metastases in lung cancer.

Dr. Benjamin Levy, Mount Sinai Health Systems, compares zoledronic acid and denosumab, two agents used for treatment of bone metastases in lung cancer.

Dr. Benjamin Levy, Mount Sinai Health Systems, compares zoledronic acid and denosumab, two agents used for treatment of bone metastases in lung cancer.

By David Avigan. This podcast describes a phase III randomized study comparing the efficacy and toxicity of Denosumab with Zolendronic Acid for the prevention of skeletal complications in patients with malignancy.