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Denosumab discontinue treatment

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https://www.readbyqxmd.com/read/29105841/vertebral-fractures-following-discontinuation-of-denosumab-a-post-hoc-analysis-of-the-randomized-placebo-controlled-freedom-trial-and-its-extension
#1
Steven R Cummings, Serge Ferrari, Richard Eastell, Nigel Gilchrist, Jens-Erik Beck Jensen, Michael McClung, Christian Roux, Ove Törring, Ivo Valter, Andrea T Wang, Jacques P Brown
Denosumab reduces bone resorption and vertebral and nonvertebral fracture risk. Denosumab discontinuation increases BTMs 3 months after a scheduled dose is omitted, reaching above-baseline levels by 6 months, and decreases BMD to baseline levels by 12 months. We analyzed the risk of new or worsening vertebral fractures, especially multiple vertebral fractures, in participants who discontinued denosumab during the FREEDOM study or its Extension. Participants received ≥2 doses of denosumab or placebo Q6M, discontinued treatment, and stayed in the study ≥7 months after the last dose...
November 4, 2017: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
https://www.readbyqxmd.com/read/29083977/examining-the-effect-of-medication-adherence-on-risk-of-subsequent-fracture-among-women-with-a-fragility-fracture-in-the-u-s-medicare-population
#2
Allison Keshishian, Natalie Boytsov, Russel Burge, Kelly Krohn, Louise Lombard, Xiang Zhang, Lin Xie, Onur Baser
BACKGROUND: In the United States, osteoporosis affects approximately 10 million people, of whom 80% are women, and it contributes a significant clinical burden to the community. Poor adherence to osteoporosis medications adds to the overall burden of illness. OBJECTIVE: To examine the association of osteoporosis medication adherence and the risk of a subsequent fracture among Medicare-enrolled women with a previous fragility fracture. METHODS: This study was a retrospective observational analysis of U...
November 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29080812/juvenile-paget-disease
#3
Stergios A Polyzos, Tim Cundy, Christos S Mantzoros
Juvenile Paget disease (JPD) is a rare disorder, mainly caused by mutations in the gene TNFRSF11B that encodes osteoprotegerin (OPG). Loss of OPG action causes generalized, extremely rapid bone turnover. The clinical manifestations are both skeletal - progressive skeletal deformity that develops in childhood - and extra-skeletal, including hearing loss, retinopathy, vascular calcification and internal carotid artery aneurysm formation. The severity of the phenotype seems to be related to the severity of TNFRSF11B gene deactivation...
October 25, 2017: Metabolism: Clinical and Experimental
https://www.readbyqxmd.com/read/28975362/significant-bone-loss-after-stopping-long-term-denosumab-treatment-a-post-freedom-study
#4
M B Zanchetta, J Boailchuk, F Massari, F Silveira, C Bogado, J R Zanchetta
We evaluate 38 elderly women who had received long-term denosumab treatment after stopping the drug. Taking into account the gain during treatment and the loss after stopping treatment, they lost 35.5% of the total gain in the spine, 44.6% of the total gain in the femoral neck, and 103.3% in the total hip. INTRODUCTION: Denosumab (DMAb) is a soluble inhibitor of the receptor activator of nuclear factor-kappaB ligand (RANKL) and, therefore, does not incorporate into the bone matrix. Consistently, DMAb discontinuation is associated with reversal of the effects attained with treatment...
October 3, 2017: Osteoporosis International
https://www.readbyqxmd.com/read/28871570/osteoporosis-drug-treatment-duration-and-management-after-discontinuation-a-position-statement-from-the-svgo-asco
#5
Christian Meier, Brigitte Uebelhart, Bérengère Aubry-Rozier, Martin Birkhäuser, Heike A Bischoff-Ferrari, Diana Frey, Reto W Kressig, Olivier Lamy, Kurt Lippuner, Petra Stute, Norbert Suhm, Serge Ferrari
Antiosteoporotic drugs are recommended in patients with fragility fractures and in patients considered to be at high fracture risk on the basis of clinical risk factors and/or low bone mineral density. As first-line treatment most patients are started with an antiresorptive treatment, i.e. drugs that inhibit osteoclast development and/or function (bisphosphonates, denosumab, oestrogens or selective oestrogen receptor modulators). In the balance between benefits and risks of antiresorptive treatment, uncertainties remain regarding the optimal treatment duration and the management of patients after drug discontinuation...
September 5, 2017: Swiss Medical Weekly
https://www.readbyqxmd.com/read/28789921/discontinuation-of-denosumab-therapy-for-osteoporosis-a-systematic-review-and-position-statement-by-ects
#6
REVIEW
Elena Tsourdi, Bente Langdahl, Martine Cohen-Solal, Bérengere Aubry-Rozier, Erik Fink Eriksen, Nuria Guañabens, Barbara Obermayer-Pietsch, Stuart H Ralston, Richard Eastell, M Carola Zillikens
INTRODUCTION: The optimal duration of osteoporosis treatment is controversial. As opposed to bisphosphonates, denosumab does not incorporate into bone matrix and bone turnover is not suppressed after its cessation. Recent reports imply that denosumab discontinuation may lead to an increased risk of multiple vertebral fractures. METHODS: The European Calcified Tissue Society (ECTS) formed a working group to perform a systematic review of existing literature on the effects of stopping denosumab and provide advice on management...
August 5, 2017: Bone
https://www.readbyqxmd.com/read/28727345/-denosumab-in-clinical-practice-beware-before-during-and-after
#7
Olivier Lamy, Elena Gonzalez-Rodriguez, Delphine Stoll, Bérengère Aubry-Rozier
Denosumab is a very effective treatment of osteoporosis, easy to use and very well tolerated. Due to some associated risks, a close clinical follow-up is necessary. Before the first injection, it is necessary to correct hypocalcaemia or vitamin D deficiency when present. Calcemia has to be followed in case of renal insufficiency. Injections of denosumab should be done scrupulously every 6 months (± 3 weeks). Discontinuation of denosumab is associated with a severe rebound effect characterized by increased markers of bone remodeling, a rapid decrease of bone density values, and a risk of multiple spontaneous vertebral fractures...
April 19, 2017: Revue Médicale Suisse
https://www.readbyqxmd.com/read/28714038/one-and-two-year-persistence-with-different-anti-osteoporosis-medications-a-retrospective-cohort-study
#8
C Reyes, C Tebe, D Martinez-Laguna, M S Ali, A Soria-Castro, C Carbonell, D Prieto-Alhambra
Adherence to anti-osteoporosis medications is poor. We carried out a cohort study using a real-world population database to estimate the persistence of anti-osteoporosis drugs. Unadjusted 2-year persistence ranged from 10.3 to 45.4%. Denosumab users had a 40% lower risk of discontinuation at 2 years compared to alendronate users. PURPOSE: The purpose of this study was to estimate real-world persistence amongst incident users of anti-osteoporosis medications. METHODS: This is a retrospective cohort using data from anonymised records and dispensation data ( www...
July 16, 2017: Osteoporosis International
https://www.readbyqxmd.com/read/28686517/osteoporosis-management
#9
Pelin Batur, Sheila Rice, Paola Barrios, Andrea Sikon
The clinical update serves as a brief review of recently published, high-impact, and potentially practice changing journal articles summarized for our readers. Topics include menopause, sexual dysfunction, breast health, contraception, osteoporosis, and cardiovascular disease. In this clinical update, we selected recent publications relevant to osteoporosis management. We highlight articles on the safety of long-term use of denosumab and bisphosphonates, fracture risk after discontinuing menopausal hormone therapy, calcium intake and cardiovascular risk, as well as the value of repeat dual X-ray absorptiometry scanning to monitor those on osteoporosis treatment...
August 2017: Journal of Women's Health
https://www.readbyqxmd.com/read/28643220/denosumab-an-emerging-therapy-in-pediatric-bone-disorders
#10
REVIEW
Alison M Boyce
PURPOSE OF REVIEW: Denosumab is an inhibitor of receptor activator of nuclear factor kappa-B ligand (RANKL), and has emerged as an important novel therapy for skeletal disorders. This article examines the use of denosumab in children. RECENT FINDINGS: Considerable safety and efficacy data exists for denosumab treatment of adults with osteoporosis, bone metastases, and giant cell tumors. Pediatric data is limited; however, evidence suggests denosumab may be beneficial in decreasing bone turnover, increasing bone density, and preventing growth of certain skeletal neoplasms in children...
August 2017: Current Osteoporosis Reports
https://www.readbyqxmd.com/read/28546097/10-years-of-denosumab-treatment-in-postmenopausal-women-with-osteoporosis-results-from-the-phase-3-randomised-freedom-trial-and-open-label-extension
#11
Henry G Bone, Rachel B Wagman, Maria L Brandi, Jacques P Brown, Roland Chapurlat, Steven R Cummings, Edward Czerwiński, Astrid Fahrleitner-Pammer, David L Kendler, Kurt Lippuner, Jean-Yves Reginster, Christian Roux, Jorge Malouf, Michelle N Bradley, Nadia S Daizadeh, Andrea Wang, Paula Dakin, Nicola Pannacciulli, David W Dempster, Socrates Papapoulos
BACKGROUND: Long-term safety and efficacy of osteoporosis treatment are important because of the chronic nature of the disease. We aimed to assess the long-term safety and efficacy of denosumab, which is widely used for the treatment of postmenopausal women with osteoporosis. METHODS: In the multicentre, randomised, double-blind, placebo-controlled, phase 3 FREEDOM trial, postmenopausal women aged 60-90 years with osteoporosis were enrolled in 214 centres in North America, Europe, Latin America, and Australasia and were randomly assigned (1:1) to receive 60 mg subcutaneous denosumab or placebo every 6 months for 3 years...
July 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28539165/drug-holidays-from-bisphosphonates-and-denosumab-in-postmenopausal-osteoporosis-emas-position-statement
#12
REVIEW
Panagiotis Anagnostis, Stavroula A Paschou, Gesthimani Mintziori, Iuliana Ceausu, Herman Depypere, Irene Lambrinoudaki, Alfred Mueck, Faustino R Pérez-López, Margaret Rees, Levent M Senturk, Tommaso Simoncini, John C Stevenson, Petra Stute, Florence A Trémollieres, Dimitrios G Goulis
BACKGROUND: Bisphosphonates and denosumab are used extensively in the treatment of postmenopausal osteoporosis. Despite their proven efficacy in the reduction of vertebral and non-vertebral fractures, their optimal duration of use has not been determined. The occurrence of adverse effects, such as osteonecrosis of the jaw (ONJ) and atypical femoral fractures (AFF), has raised the issue of bisphosphonate or denosumab discontinuation ("drug holiday") after a certain treatment period. AIM: To assess the effect of bisphosphonate and denosumab discontinuation on fracture risk, as well as its possible benefits in reducing the risk of adverse effects...
July 2017: Maturitas
https://www.readbyqxmd.com/read/28485692/cost-effectiveness-of-denosumab-versus-zoledronic-acid-for-preventing-skeletal-related-events-in-the-czech-republic
#13
Joaquim Cristino, Jíndřich Finek, Petra Jandova, Martin Kolek, Bálint Pásztor, Christina Giannopoulou, Yi Qian, Tomas Brezina, Mickael Lothgren
AIMS: This study assessed the cost-effectiveness of the subcutaneous RANKL inhibitor, denosumab, vs the intravenous bisphosphonate, zoledronic acid, for the prevention of skeletal-related events (SREs) in patients with prostate cancer, breast cancer, and other solid tumors (OST) in the Czech Republic. MATERIALS AND METHODS: A lifetime Markov model was developed to compare the effects of denosumab and zoledronic acid on costs (including drug costs and administration, patient management, SREs, and adverse events), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios from a national payer perspective...
June 7, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28451403/successful-treatment-with-denosumab-in-a-patient-with-sacral-giant-cell-tumor-of-bone-refractory-to-combination-therapy-with-arterial-embolization-and-zoledronic-acid-a-case-report
#14
Shunji Nishimura, Kazuhiko Hashimoto, Akihiro Tan, Yukinobu Yagyu, Masao Akagi
Giant cell tumor of bone (GCTB) is commonly treated with surgery; however, surgery of GCTB in the sacrum may be challenging due to the associated risk. A conservative approach may be selective arterial embolization or zoledronic acid (ZOL) treatment; however, there are currently no studies investigating the efficacy of combining these two treatments. Denosumab may also be used; however, to the best of our knowledge, there are no reports of a stepwise approach for the use of all three treatments in a single patient...
March 2017: Molecular and Clinical Oncology
https://www.readbyqxmd.com/read/28449657/influence-of-subject-discontinuation-on-long-term-nonvertebral-fracture-rate-in-the-denosumab-freedom-extension-study
#15
Jonathan D Adachi, Henry G Bone, Nadia S Daizadeh, Paula Dakin, Socrates Papapoulos, Peyman Hadji, Chris Recknor, Michael A Bolognese, Andrea Wang, Celia J F Lin, Rachel B Wagman, Serge Ferrari
BACKGROUND: Denosumab treatment for up to 8 years in the FREEDOM study and Extension was associated with low fracture incidence. It was not clear whether subjects who discontinued during the study conduct had a higher risk of fracture than those who remained enrolled, thereby underestimating the true fracture risk for the entire trial cohort. Thus, we explored the influence of early withdrawals on nonvertebral fracture incidence during the Extension study. METHODS: To understand the potential effect of depletion of susceptible subjects on fracture incidence, we first evaluated subject characteristics in patients who were enrolled in the Extension vs those who were not...
April 27, 2017: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/28382583/use-and-safety-of-denosumab-in-cancer-patients
#16
Alba Manzaneque, Cristian Chaguaceda, Mireia Mensa, Carla Bastida, Natàlia Creus-Baró
Background Few data have been reported on the use and safety of denosumab in patients with solid tumors and bone metastasis in clinical practice. Objectives To describe the use of denosumab and to analyze its adverse effects (AE) in tertiary hospital cancer outpatients. Methods Retrospective study of patients who started denosumab between January 2013 and June 2015. We recorded demographic, clinical, and treatment-related variables, as well as the reasons for discontinuation and AE. Results The study population comprised 104 patients, of whom 86 (82...
June 2017: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/28359721/western-osteoporosis-alliance-clinical-practice-series-evaluating-the-balance-of-benefits-and-risks-of-long-term-osteoporosis-therapies
#17
REVIEW
David A Hanley, Michael R McClung, K Shawn Davison, Larry Dian, Steve T Harris, Paul D Miller, E Michael Lewiecki, David L Kendler
Osteoporosis is a chronic disease that requires life-long strategies to reduce fracture risk. Few trials have investigated the balance of benefits and risk with long-term use of osteoporosis therapies, and fewer still have investigated the consequences of treatment discontinuation. The best available evidence suggests that up to 10 years of treatment with an oral bisphosphonate maintains the degree of fracture risk reduction observed in the 3-year registration trials. With denosumab, 10 years of therapy appears to provide fracture risk reduction similar to or better than that observed in the 3-year registration trial...
July 2017: American Journal of Medicine
https://www.readbyqxmd.com/read/28324746/denosumab-in-advanced-unresectable-giant-cell-tumour-of-bone-gctb-for-how-long
#18
E Palmerini, N S Chawla, S Ferrari, M Sudan, P Picci, E Marchesi, M Piccinni Leopardi, I Syed, K K Sankhala, P Parthasarathy, W E Mendanha, M Pierini, A Paioli, S P Chawla
BACKGROUND: Giant-cell tumours of bone (GCTB) are RANK/RANK-ligand (RANKL) positive, aggressive and progressive osteolytic tumours. Denosumab, a RANKL inhibitor, was FDA-approved for adults and skeletally mature adolescents with unresectable GCTB or when surgical resection is likely to result in severe morbidity. Data on long-term toxicity and activity of denosumab monthly 'GCTB-schedule' (120 mg per 12/year, 1440 mg total dose/year) are lacking. METHODS: Patients with GCTB receiving denosumab, 120 mg on days 1, 8, 15, 29 and every 4 weeks thereafter, from 2006 to 2015 treated in two centres were included...
May 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28283537/increased-osteoclastogenesis-in-patients-with-vertebral-fractures-following-discontinuation-of-denosumab-treatment
#19
Athanasios D Anastasilakis, Maria P Yavropoulou, Polyzois Makras, Grigorios T Sakellariou, Fotini Papadopoulou, Spyridon Gerou, Socrates E Papapoulos
OBJECTIVE: To test the hypothesis that rebound of bone remodeling is responsible for clinical vertebral fractures reported in a few patients with osteoporosis after cessation of denosumab treatment. DESIGN: In this case-control study we compared clinical and biochemical characteristics of postmenopausal women with clinical vertebral fractures 8-16 months after the last injection of denosumab (Dmab/Fx+, n = 5) with those of treatment-naïve women with such fractures (Fx+, n = 5)...
June 2017: European Journal of Endocrinology
https://www.readbyqxmd.com/read/28247363/atypical-fracture-of-the-sternum-after-long-term-alendronate-plus-cholecalciferol-treatment-a-case-report
#20
Luis H Martín Arias, Pilar García Ortega, María Sáinz Gil, Ester Navarro García, Carlos Treceño Lobato, Virginia Delgado Armas
A 55-year-old woman developed an atraumatic sternum fracture during treatment with alendronate for osteoporosis. The woman received alendronate 70 mg in combination with cholecalciferol 5600 IU once weekly, as well as nonsteroidal anti-inflammatory drugs. After 4 years of treatment, following a dorsal flexion with no direct thoracic trauma, the patient suffered a fracture of the sternum, with an X-ray revealing sternal body fracture. This fracture was seen to be transverse, noncomminuted and without displacement...
December 2017: Drug Safety—Case Reports
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