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Denosumab discontinue treatment

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https://www.readbyqxmd.com/read/29232486/an-essential-warning-editorial-on-vertebral-fractures-after-discontinuation-of-denosumab-a-post-hoc-analysis-of-the-randomized-placebo-controlled-freedom-trial-its-extension
#1
Benjamin Leder
Over the past two decades, osteoporosis treatment options have expanded greatly and physicians and patients are now able to choose among several classes of medications and numerous specific drugs. As these options have grown, however, the choice of which medication to prescribe and how to balance the risks and benefits in specific populations and individual patients has become increasingly complex. This complexity, in turn, combined with the proliferation of well-publicized reports of rare but serious side effects, is exacerbating the recent trend of declining rates of osteoporosis treatment...
December 12, 2017: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
https://www.readbyqxmd.com/read/29230512/rebound-associated-vertebral-fractures-after-discontinuation-of-denosumab-for-the-treatment-of-maxillitis
#2
R Niimi, T Kono, A Nishihara, M Hasegawa, T Kono, A Sudo
We reported a 69-year-old female who discontinued denosumab due to dental treatment and subsequently suffered rebound-associated vertebral fractures 10 months after the last injection. This case raised an alarm regarding the discontinuation of denosumab for dental treatment. Denosumab, a human monoclonal antibody administered by subcutaneous injection, to the best of our knowledge, is the only fully investigated inhibitor of receptor activator of nuclear factor kappa B ligand. Discontinuation of denosumab leads to bone turnover rebound and rapid bone mineral density loss...
December 11, 2017: Osteoporosis International
https://www.readbyqxmd.com/read/29196083/the-good-and-the-bad-about-the-2017-american-college-of-physicians-osteoporosis-guidelines
#3
Violet Lagari, Tara Gavcovich, Silvina Levis
PURPOSE: The American College of Physicians (ACP) published a set of guidelines on how to prevent fractures in men and women with low bone density or osteoporosis. As the population ages, the overall risk of fractures increases, thus burdening the health care system. These guidelines review current evidence for osteoporosis management, providing an update to the previous 2008 ACP's guidelines. METHODS: The ACP put forth 6 recommendations addressing the complexities in osteoporosis management based on evidence available through October 2016 with a focus on bisphosphonates, calcium, vitamin D, and estrogen...
November 28, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29187046/denosumab-improves-bone-mineral-density-in-patients-with-intestinal-failure-receiving-home-parenteral-nutrition-results-from-a-randomized-controlled-clinical-trial
#4
Kinga Szczepanek, Michal Pedziwiatr, Stanisław Klek
AIM: Low bone mineral density (BMD) is commonly reported in patients receiving home parenteral nutrition (HPN). Oral and intravenous calcium, vitamin D, and bisphosphonates have been used to treat BMD but with low efficiency due to their limited absorption and patient compliance. Denosumab is a new drug that helps prevent osteoclast development and activation and led to decreased bone resorption in some studies. The aim of this study was to assess its value in HPN patients. METHODS: Between November 2011 and March 2013, 49 patients receiving HPN (29 women, 20 men, mean age 55...
March 1, 2017: JPEN. Journal of Parenteral and Enteral Nutrition
https://www.readbyqxmd.com/read/29181213/therapeutic-management-of-a-substantial-pelvic-aneurysmatic-bone-cyst-including-the-off-label-use-of-denosumab-in-a-35-year-old-female-patient
#5
D Ntalos, M Priemel, C Schlickewei, D M Thiesen, J M Rueger, A S Spiro
Aneurysmal bone cysts (ABC) are benign bone tumors, which are highly vascularized. The main course of treatment is curettage followed by bone grafting or cement insertion. Still recurrence remains a main problem for patients. Denosumab is a monoclonal antibody, which acts as an inhibitor of the RANK/RANKL pathway, diminishing bone turnover. Recent case reports have shown that Denosumab can be a promising therapeutic agent for people suffering from therapy-resistant ABC. We report the case of a 35-year-old female patient presenting with a pronounced ABC of the pelvis...
2017: Case Reports in Orthopedics
https://www.readbyqxmd.com/read/29105841/vertebral-fractures-after-discontinuation-of-denosumab-a-post-hoc-analysis-of-the-randomized-placebo-controlled-freedom-trial-and-its-extension
#6
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 bone turnover markers 3 months after a scheduled dose is omitted, reaching above-baseline levels by 6 months, and decreases bone mineral density (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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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