ANZBMS Newsletter July 2020
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Denosumab Versus Romosozumab for Postmenopausal Osteoporosis Treatment
www.nature.com/scientificreports OPEN Denosumab versus romosozumab for postmenopausal osteoporosis treatment Tomonori Kobayakawa1, Akiko Miyazaki2, Makoto Saito3, Takako Suzuki2,4, Jun Takahashi2 & Yukio Nakamura2* Denosumab and romosozumab, a recently approved new drug, are efective and widely known molecular-targeted drugs for postmenopausal osteoporosis treatment. However, no studies have directly compared their therapeutic efects or safety in postmenopausal osteoporosis. This retrospective observational registry study compared the efcacy of 12-month denosumab or romosozumab treatment in postmenopausal osteoporosis patients. The primary outcome was the change in bone mineral density (BMD) at the lumbar spine. Secondary outcomes included BMD changes at the total hip and femoral neck, changes in bone turnover markers, and adverse events. Propensity score matching was employed to assemble patient groups with similar baseline characteristics. Sixty-nine patients each received either denosumab or romosozumab for 12 months. The mean 12-month percentage change from baseline in lumbar spine BMD was 7.2% in the denosumab group and 12.5% in the romosozumab group, indicating a signifcant diference between the groups. The percentage changes in BMD at both the total hip and femoral neck were also signifcantly higher at 12 months in the romosozumab group than in the denosumab group. In denosumab patients, bone formation and bone resorption markers were signifcantly decreased at 6 and 12 months from baseline. In the romosozumab group, the bone formation marker was signifcantly increased at 6 months and then returned to baseline, while the bone resorption marker was signifcantly decreased at both time points. Adverse events were few and predominantly minor in both groups, with no remarkable diference in the incidence of new vertebral fractures. -
Increased Bone Mineral Density for 1 Year of Romosozumab, Vs Placebo, Followed by 2 Years of Denosumab in the Japanese Subgroup
Archives of Osteoporosis (2019) 14:59 https://doi.org/10.1007/s11657-019-0608-z ORIGINAL ARTICLE Increased bone mineral density for 1 year of romosozumab, vs placebo, followed by 2 years of denosumab in the Japanese subgroup of the pivotal FRAME trial and extension Akimitsu Miyauchi1 & Rajani V. Dinavahi2 & Daria B. Crittenden2 & Wenjing Yang2 & Judy C. Maddox2 & Etsuro Hamaya3 & Yoichi Nakamura3 & Cesar Libanati4 & Andreas Grauer2 & Junichiro Shimauchi3 Received: 1 March 2019 /Accepted: 18 May 2019 # The Author(s) 2019 Abstract Summary Romosozumab, which binds sclerostin, rebuilds the skeletal foundation before transitioning to antiresorptive treat- ment. This subgroup analysis of an international, randomized, double-blind study in postmenopausal women with osteoporosis showed efficacy and safety outcomes for romosozumab followed by denosumab in Japanese women were generally consistent with those for the overall population. Purpose In the international, randomized, double-blind, phase 3 FRActure study, in postmenopausal woMen with ostEoporosis (FRAME; NCT01575834), romosozumab followed by denosumab significantly improved bone mineral density (BMD) and reduced fracture risk. This report evaluates Japanese women in FRAME. Methods Postmenopausal women with osteoporosis (T-score − 3.5 to − 2.5 at total hip or femoral neck) received romosozumab 210 mg or placebo subcutaneously monthly for 12 months, then each group received denosumab 60 mg subcutaneously every 6 months for 24 months. The key endpoint for Japanese women was BMD change. Other endpoints included new vertebral, clinical, and nonvertebral fracture; the subgroup analysis did not have adequate power to demonstrate statistically significant reductions. Results Of 7180 enrolled subjects, 492 (6.9%) were Japanese (247 romosozumab, 245 placebo). -
Denosumab, Raloxifene, Romosozumab and Teriparatide to Prevent Osteoporotic Fragility Fractures: a Systematic Review and Economic Evaluation
Journals Library Health Technology Assessment Volume 24 • Issue 29 • June 2020 ISSN 1366-5278 Denosumab, raloxifene, romosozumab and teriparatide to prevent osteoporotic fragility fractures: a systematic review and economic evaluation Sarah Davis, Emma Simpson, Jean Hamilton, Marrissa Martyn-St James, Andrew Rawdin, Ruth Wong, Edward Goka, Neil Gittoes and Peter Selby DOI 10.3310/hta24290 Denosumab, raloxifene, romosozumab and teriparatide to prevent osteoporotic fragility fractures: a systematic review and economic evaluation Sarah Davis ,1* Emma Simpson ,1 Jean Hamilton ,1 Marrissa Martyn-St James ,1 Andrew Rawdin ,1 Ruth Wong ,1 Edward Goka ,1 Neil Gittoes 2 and Peter Selby 3 1Health Economics and Decision Science, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK 2University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK 3School of Medical Sciences, University of Manchester, Manchester, UK *Corresponding author Declared competing interests of authors: Neil Gittoes reports personal fees for being a member of the advisory board to Union Chimique Belge (UCB) S.A. (Brussels, Belgium) and personal fees for contributing to educational meeting sponsored by Eli Lilly and Company (Indianapolis, IN, USA), outside the submitted work. He is also a trustee of the National Osteoporosis Society, a member of the advisory board of the National Osteoporosis Guideline Group and Deputy Chairperson of the Specialised Endocrinology Clinical Reference Group, NHS England. Published June 2020 DOI: 10.3310/hta24290 This report should be referenced as follows: Davis S, Simpson E, Hamilton J, James MM-S, Rawdin A, Wong R, et al. Denosumab, raloxifene, romosozumab and teriparatide to prevent osteoporotic fragility fractures: a systematic review and economic evaluation. -
Congress Report
ValEncia spain CONGRESS REPORT a proDucT of This publicaTion is supporTED by Foreword from Contents Anna Teti, ECTS president Progress for rare diseases at ECTS 1 ECTS 2018 supports Camurati- The ECTS 2018 congress was again Engelmann patients’ association 7 exciting and successful. Around ECTS perspectives on clinical hot topics 9 1000 delegates attended the Omics moving forward to practical translation 11 meeting in Valencia, for teaching and learning in a ECTS Steven Boonen Award 14 relaxed and lively atmosphere. Our pre-congress day Screening for fracture risk in osteoporosis 17 was also very successful and included the Mellanby training course, the first ECTS/ICCBH workshop on ECTS and ASBMR debate screening for fracture risk 19 Rare Bone Diseases, the East meets West events, 10 Bone and ageing 21 very successful Working Gro ups and the ECTS Risk factors for bone disease 24 Academy events. Scientists were able to take advantage of the networking opportunities, clinicians could hear Clinical weight loss and bone 28 about the latest developments and best clinical Management of clinical vertebral fractures 30 practice, and young investigators could benefit from Exploring the human microbiome 33 contact with experienced colleagues and opinion New data on efficacy of osteoporosis therapies 36 leaders, including through our Meet the Expert Advances in regenerative medicine 40 sessions. ECTS aims at promoting crosstalk between Fish as a model of skeletal diseases 42 the generations and we believe this goal was fully New insights into bone and cartilage biology 44 achieved in Valencia, particularly as a result of the Cancer and bone 48 tremendous efforts of our ECTS Academy members. -
Immunfarmakológia Immunfarmakológia
Gergely: Immunfarmakológia Immunfarmakológia Prof Gergely Péter Az immunpatológiai betegségek döntő többsége gyulladásos, és ennek következtében általában szövetpusztulással járó betegség, melyben – jelenleg – a terápia alapvetően a gyulladás csökkentésére és/vagy megszűntetésére irányul. Vannak kizárólag gyulladásgátló gyógyszereink és vannak olyanok, amelyek az immunreakció(k) bénításával (=immunszuppresszió révén) vagy emellett vezetnek a gyulladás mérsékléséhez. Mind szerkezetileg, mind hatástanilag igen sokféle csoportba oszthatók, az alábbi felosztás elsősorban didaktikus célokat szolgál. 1. Nem-szteroid gyulladásgátlók (‘nonsteroidal antiinflammatory drugs’ NSAID) 2. Kortikoszteroidok 3. Allergia-elleni szerek (antiallergikumok) 4. Sejtoszlás-gátlók (citosztatikumok) 5. Nem citosztatikus hatású immunszuppresszív szerek 6. Egyéb gyulladásgátlók és immunmoduláns szerek 7. Biológiai terápia 1. Nem-szteroid gyulladásgátlók (NSAID) Ezeket a vegyületeket, melyek őse a szalicilsav (jelenleg, mint acetilszalicilsav ‘aszpirin’ használatos), igen kiterjedten alkalmazzák a reumatológiában, az onkológiában és az orvostudomány szinte minden ágában, ahol fájdalom- és lázcsillapításra van szükség. Egyes felmérések szerint a betegek egy ötöde szed valamilyen NSAID készítményt. Szerkezetük alapján a készítményeket több csoportba sorolhatjuk: szalicilátok (pl. acetilszalicilsav) pyrazolidinek (pl. fenilbutazon) ecetsav származékok (pl. indometacin) fenoxiecetsav származékok (pl. diclofenac, aceclofenac)) oxicamok (pl. piroxicam, meloxicam) propionsav -
The Two Tontti Tudiul Lui Hi Ha Unit
THETWO TONTTI USTUDIUL 20170267753A1 LUI HI HA UNIT ( 19) United States (12 ) Patent Application Publication (10 ) Pub. No. : US 2017 /0267753 A1 Ehrenpreis (43 ) Pub . Date : Sep . 21 , 2017 ( 54 ) COMBINATION THERAPY FOR (52 ) U .S . CI. CO - ADMINISTRATION OF MONOCLONAL CPC .. .. CO7K 16 / 241 ( 2013 .01 ) ; A61K 39 / 3955 ANTIBODIES ( 2013 .01 ) ; A61K 31 /4706 ( 2013 .01 ) ; A61K 31 / 165 ( 2013 .01 ) ; CO7K 2317 /21 (2013 . 01 ) ; (71 ) Applicant: Eli D Ehrenpreis , Skokie , IL (US ) CO7K 2317/ 24 ( 2013. 01 ) ; A61K 2039/ 505 ( 2013 .01 ) (72 ) Inventor : Eli D Ehrenpreis, Skokie , IL (US ) (57 ) ABSTRACT Disclosed are methods for enhancing the efficacy of mono (21 ) Appl. No. : 15 /605 ,212 clonal antibody therapy , which entails co - administering a therapeutic monoclonal antibody , or a functional fragment (22 ) Filed : May 25 , 2017 thereof, and an effective amount of colchicine or hydroxy chloroquine , or a combination thereof, to a patient in need Related U . S . Application Data thereof . Also disclosed are methods of prolonging or increasing the time a monoclonal antibody remains in the (63 ) Continuation - in - part of application No . 14 / 947 , 193 , circulation of a patient, which entails co - administering a filed on Nov. 20 , 2015 . therapeutic monoclonal antibody , or a functional fragment ( 60 ) Provisional application No . 62/ 082, 682 , filed on Nov . of the monoclonal antibody , and an effective amount of 21 , 2014 . colchicine or hydroxychloroquine , or a combination thereof, to a patient in need thereof, wherein the time themonoclonal antibody remains in the circulation ( e . g . , blood serum ) of the Publication Classification patient is increased relative to the same regimen of admin (51 ) Int . -
Romosozumab Monoclonal Antibody- Sclerostin
ROMOSOZUMAB MONOCLONAL ANTIBODY- SCLEROSTIN JOSEPH M. LANE, MD HOSPITAL FOR SPECIAL SURGERY Weill Cornell Medicine NEW YORK, NY Disclosure Joseph M. Lane, MD CollPlant, Inc: Stock Options Merck: Research Support On Foundation: Consultant/Board Member Radius Health, Inc: Consultant Terumo BCT Consultant NIH Study Section Research Grants OSTEOPOROSIS Fragility (Iow energy) Fractures Hip Fracture Mortality (1 year) Female ~ 24% Male ~ 30% 70% Lose One Level Function ANTIRESORPTION Bisphosphonates ↓R ↓F Denosumab ↓R SERMS ↓R Only spine ANABOLIC Teriparatide ↑F Late ↑R Abaloparatide ↑F Late ↑R ROM0S0ZUMAB ↑F ↓R ROMOSOZUMAB SCLEROSTIN MONOCLONAL ANTIBODY WHAT DO WE KNOW ABOUT SCLEROSTIN? Odd diseases Wnt Bone Pathway SCLEROSTIOSIS Inactivating Mutation SOST (codes for sclerostin) van Buchan Disease less severe ↑ Bone Mass ↓ Fractures SCLEROSTIN Secreted By Osteocyte (low mechanical load) Binds to LRP 5/6 Inactivates Wnt Pathway Ceases Osteoblastic Bone Formation Shah AD et al. Int J Womens Health, 2015. Pre-Clinical Data Romosozumab Genetic Deficiency Sclerostin Rodents ↑Bone Mass ↑ Bone Formation Trabecular Cortical Normal Bone Quality ↑Bone Strength Normal Mineralization Lack of Brittleness Sclerostin Monoclonal Antibody Animals ↑ Trabecular/Cortical Thickness ↓ Cortical Porosity Corrected Ovariectomy ↑ Bone Density LS, FN, Prox Tib, Distal Radius RANKL INHIBITOR AMPLIFIED GAIN Comparison of Changes in Areal And Volumetric BMD 12 Months Romo vs Teriparatide Romo Teriparatide 210mg qm 20ug/d Areal BMD (DXA) L-Spine 12.3%* 6.9%* Total Hip 3.9%* 0.8% Integral V-metric BMD (QCT) 17.7% * L-Spine 4.1% 12.9%* Total Hip 1.2% * p<.05 Genant JBMR 2017 Comparison of Changes in Estimated Bone Strength Finite Element Analyses Romo Teriparatide 210mg qm 20μg/d Estimated Bone Strength FEA by QCT 27.3%* 18.5% L-Spine 12.3%* 3.6%* 18.5% Total Hip -0.7% * p<.05 Keaveny JBMR 2017 Romosozumab vs. -
Evenity® (Romosozumab)
Evenity® (Romosozumab) Last Review Date: September 23, 2019 Number: MG.MM.PH.195 Medical Guideline Disclaimer Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. -
Bone Quality in Chronic Kidney Disease Patients: Current Concepts and Future Directions – Part II
University of Kentucky UKnowledge Internal Medicine Faculty Publications Internal Medicine 4-26-2021 Bone Quality in Chronic Kidney Disease Patients: Current Concepts and Future Directions – Part II Kamyar Asadipooya University of Kentucky, [email protected] Mohamed Abdalbary University of Kentucky, [email protected] Yahya Ahmad University of Kentucky, [email protected] Elijah Kakani University of Kentucky Marie-Claude Monier-Faugere University of Kentucky, [email protected] See next page for additional authors Follow this and additional works at: https://uknowledge.uky.edu/internalmedicine_facpub Part of the Endocrinology, Diabetes, and Metabolism Commons, Internal Medicine Commons, and the Nephrology Commons Right click to open a feedback form in a new tab to let us know how this document benefits ou.y Repository Citation Asadipooya, Kamyar; Abdalbary, Mohamed; Ahmad, Yahya; Kakani, Elijah; Monier-Faugere, Marie-Claude; and El-Husseini, Amr, "Bone Quality in Chronic Kidney Disease Patients: Current Concepts and Future Directions – Part II" (2021). Internal Medicine Faculty Publications. 249. https://uknowledge.uky.edu/internalmedicine_facpub/249 This Review is brought to you for free and open access by the Internal Medicine at UKnowledge. It has been accepted for inclusion in Internal Medicine Faculty Publications by an authorized administrator of UKnowledge. For more information, please contact [email protected]. Bone Quality in Chronic Kidney Disease Patients: Current Concepts and Future Directions – Part II Digital Object Identifier (DOI) https://doi.org/10.1159/000515542 Notes/Citation Information Published in Kidney Diseases. © 2021 The Author(s) Published by S. Karger AG, Basel This article is licensed under the Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC). -
1 Sarcopenic Obesity and Its Temporal Associations With
Sarcopenic Obesity and its Temporal Associations with Changes in Bone Mineral Density, Incident Falls and Fractures in Older Men: The Concord Health and Ageing in Men Project 1,2 3 4,5,6 5 5 David Scott , Markus Seibel , Robert Cumming Vasi Naganathan , Fiona Blyth , David G Le Couteur7, David J Handelsman8, Louise M Waite5, Vasant Hirani 5,9 Affiliations: 1 School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia 2 Department of Medicine and Australian Institute of Musculoskeletal Science, Melbourne Medical School – Western Campus, The University of Melbourne, St Albans, Victoria, Australia 3 Bone Research Program, ANZAC Research Institute, and Dept of Endocrinology & Metabolism, Concord Hospital, The University of Sydney, New South Wales, Sydney, Australia. 4 School of Public Health, University of Sydney, New South Wales, Sydney, Australia. 5 Centre for Education and Research on Ageing, Concord Hospital, University of Sydney, New South Wales, Sydney, Australia. 6 The ARC Centre of Excellence in Population Ageing Research, University of Sydney, New South Wales, Sydney, Australia. 7 ANZAC Research Institute & Charles Perkins Centre, University of Sydney, New South Wales, Sydney, Australia. 8 Department of Andrology, Concord Hospital & ANZAC Research Institute, University of Sydney, New South Wales, Sydney, Australia. 9 School of Life and Environmental Sciences, Charles Perkins Centre, University of Sydney, New South Wales, Sydney, Australia. 1 Conflicts of interest: The authors declare that they have no conflict of interest. Corresponding Author: Dr. David Scott School of Clinical Sciences at Monash Health, Monash University Clayton, Victoria, Australia 3168 Email: [email protected] Telephone: +61 3 8572 2397 Fax: +61 3 9594 6437 Abstract Body composition and muscle function have important implications for falls and fractures in older adults. -
P&T Summary 2Q2019
BLUE SHIELD OF CALIFORNIA SECOND QUARTER 2019 FORMULARY AND MEDICATION POLICY UPDATES EFFECTIVE AUGUST 1, 2019 for Large Group, Small Group, and Individual & Family Plans The Blue Shield of California (BSC) Pharmacy and Therapeutics (P&T) Committee, consisting of network physicians and pharmacists, regularly evaluates drugs for formulary inclusion and medication policy coverage criteria. The second quarter 2019 P&T Committee decisions on formulary changes and medication policy changes, which apply to Commercial members with an outpatient drug benefit, are summarized below: PHARMACY BENEFIT FORMULARY UPDATE: Please refer to the appropriate drug formulary posted on our website for the following information: • Quantity limits, if applicable, for specific drugs • Formulary status of newly available strengths of existing drugs. Note: The formulary status of newly available strengths of existing drugs will have the same formulary status as the existing strengths unless otherwise noted. • Non-formulary and non-preferred generic drugs that do not require prior authorization or step therapy • Brand-name medications that are now non-formulary or non-preferred because these medications have newly available generic equivalents covered on the formulary Formularies are available at blueshieldca.com/pharmacy. Select the appropriate drug formulary – “Standard Drug Formulary” or “Plus Drug Formulary”. Summary of changes to the Medicare formularies are available at blueshieldca.com/pharmacy. Select “Medicare Drug Formulary”, then select the appropriate -
Brotherhood of BROTHERHOOD St Laurence and Community Aid Abroad of S! LAURENCE Heiping Peopte David Scott Buitd Better Iives He Got Things Done
A memoir of Gerard Kennedy Tucker, Angiican priest, founder of the Brotherhood of BROTHERHOOD st Laurence and Community Aid Abroad of S! LAURENCE Heiping peopte David Scott buitd better iives He got things done a memoir of Gerard Kennedy Tucker, Angiican priest, founder of The Brotherhood of St Laurence and Community Aid Abroad David Scott 'Not everyone who says to me, Lord, Lord shalt enter the kingdom of heaven but he that doeth the wilt of my Father' Matthew 7:21. First published in November 2000 by the Brotherhood of St Laurence 67 Brunswick Street Fitzroy VIC 3065 Telephone (03) 9483 1183 www.bsl.org.au Scott, David He got things done: a memoir of Gerard Kennedy Tucker, Anglican Priest, founder of The Brotherhood of St Laurence and Community Aid Abroad ISBN 1-876250-40-2 @ Brotherhood of St Laurence, 2000 This book is copyright. Apart from fair dealing for the purpose of private study, research, criticism, or review, as permitted under the Copyright Act, no part may be reproduced by any process without written permission. Enquiries should be addressed to the publisher. C o f e /? f s Introduction 1 Early life 7 After the war 15 A personal reflection 21 Notes 33 //7ff0(y;vCf/0/7 In the early light at 6.30 am on 7 November 1944, two Anglican priests, Gerard Kennedy Tucker and Frank Coaldrake, and welfare officer Tony Bishop occupied the verandah of a house in St James Road in the Melbourne suburb of Armadale. They would remain, they said, until the sub-tenant vacated to allow the ill, 85-year-old owner to spend her last days in her own home.