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Denosumab discontinue treatment

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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
#1
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...
May 22, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28539165/drug-holidays-from-bisphosphonates-and-denosumab-in-postmenopausal-osteoporosis-emas-position-statement
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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...
March 27, 2017: American Journal of Medicine
https://www.readbyqxmd.com/read/28324746/denosumab-in-advanced-unresectable-giant-cell-tumour-of-bone-gctb-for-how-long
#8
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
#9
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
#10
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
https://www.readbyqxmd.com/read/28240371/clinical-features-of-24-patients-with-rebound-associated-vertebral-fractures-after-denosumab-discontinuation-systematic-review-and-additional-cases
#11
Athanasios D Anastasilakis, Stergios A Polyzos, Polyzois Makras, Berengere Aubry-Rozier, Stella Kaouri, Olivier Lamy
We aimed to study the clinical and imaging characteristics of patients sustaining vertebral fractures after denosumab discontinuation. For this purpose, we conducted a computerized advanced literature search that identified 13 published cases, and we additionally included another 11 new cases from our centers. Twenty-four postmenopausal women with vertebral fracture(s) after denosumab discontinuation, experiencing 112 fractures in total, were analyzed. The mean number of fractures per patient was 4.7. The most commonly affected vertebrae were T12 and L1...
June 2017: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
https://www.readbyqxmd.com/read/28144701/observations-following-discontinuation-of-long-term-denosumab-therapy
#12
M R McClung, R B Wagman, P D Miller, A Wang, E M Lewiecki
Stopping denosumab after 8 years of continued treatment was associated with bone loss during a 1-year observation study in patients who were not prescribed osteoporosis treatment. Bone loss was attenuated in patients who began another osteoporosis therapy. Treatment to prevent bone loss upon stopping denosumab should be considered. INTRODUCTION: This study aimed to understand osteoporosis management strategies during a 1-year observational follow-up after up to 8 years of denosumab treatment in a phase 2 study...
May 2017: Osteoporosis International
https://www.readbyqxmd.com/read/28105885/denosumab-in-patients-with-giant-cell-tumor-of-bone-in-norway-results-from-a-nationwide-cohort
#13
Kjetil Boye, Nina Louise Jebsen, Olga Zaikova, Heidi Knobel, Ayca M Løndalen, Clement S Trovik, Odd R Monge, Kirsten Sundby Hall
BACKGROUND: Denosumab is a relatively new treatment option for patients with giant-cell tumor of bone (GCTB). The purpose of this study was to report the results for patients treated in Norway. MATERIALS AND METHODS: Patients treated with denosumab for GCTB were identified from the clinical databases at the Norwegian sarcoma reference centers. Data were retrieved from the clinical databases and supplemented by retrospective review of patient records. Denosumab was given as a subcutaneous injection every 4 weeks with loading doses on day 8 and 15 in cycle 1...
March 2017: Acta Oncologica
https://www.readbyqxmd.com/read/28098117/denosumab-for-the-treatment-of-bisphosphonate-resistant-hypercalcemia-in-a-hemodialysis-patient
#14
Omar Dahmani, Christine Sophoclis, Malika Kebir, Djemai Bouguern, Aboubacry Sakho, Pascale Demarchi
The acronym of malignancy, iatrogenic, intoxication and immobilization, sarcoidosis, hyperparathyroidism and hyperthyroidism, milk-alkali syndrome, and paget is very helpful in diagnosing hypercalcemia. We report on a 94-year-old patient with history of end-stage renal failure secondary to benign nephroangiosclerosis, who was on maintenance hemodialysis during dialysis, his blood chemistry revealed mild hypercalcemia (2.66 mmol/L) with normal level of intact primary hyperparathyroidism (32.37 ng/mL) mandating the discontinuation of Vitamin D[3]...
January 2017: Saudi Journal of Kidney Diseases and Transplantation
https://www.readbyqxmd.com/read/28058444/frequency-of-discontinuation-of-injectable-osteoporosis-therapies-in-us-patients-over-2%C3%A2-years
#15
A Modi, S Sajjan, R Insinga, J Weaver, E M Lewiecki, S T Harris
Little is known about treatment patterns with injectable osteoporosis therapies. At 12 months, the probability of discontinuation was 69.1% among patients using ibandronate, followed by teriparatide (67.1%), zoledronic acid (59.2%), and denosumab (48.8%). By 24 months, discontinuation was higher for each treatment. The majority of US patients discontinue injectable osteoporosis treatment by the end of the first year following initiation. INTRODUCTION: This study was designed to assess the frequency of treatment discontinuation over time among patients who initiate injectable osteoporosis therapies...
January 5, 2017: Osteoporosis International
https://www.readbyqxmd.com/read/28035494/antiresorptive-agent-related-osteonecrosis-of-the-jaw-position-paper-2017-of-the-japanese-allied-committee-on-osteonecrosis-of-the-jaw
#16
REVIEW
Toshiyuki Yoneda, Hiroshi Hagino, Toshitsugu Sugimoto, Hiroaki Ohta, Shunji Takahashi, Satoshi Soen, Akira Taguchi, Toshihiko Nagata, Masahiro Urade, Takahiko Shibahara, Satoru Toyosawa
Antiresorptive agent-related osteonecrosis of the jaw (ARONJ) is an intractable, though rare, complication in cancer patients with bone metastases and patients with osteoporosis who are treated with antiresorptive agents, including bisphosphonates and denosumab. Despite the more than 10 years that have passed since the first cases of bisphosphonate-related osteonecrosis of the jaw (BRONJ) were reported, our understanding of the epidemiology and pathophysiology of ARONJ remains limited, and data supported by evidence-based medicine are still sparse...
January 2017: Journal of Bone and Mineral Metabolism
https://www.readbyqxmd.com/read/27823978/clinical-characteristics-and-prognoses-of-six-patients-with-multicentric-giant-cell-tumor-of-the-bone
#17
Chenglei Liu, Yawen Tang, Mei Li, Qiong Jiao, Huizhen Zhang, Qingcheng Yang, Weiwu Yao
Multicentric giant cell tumor of the bone (MGCT) is a rare entity whose radiographic, pathological and biological features remain confusing. We retrospectively reviewed six patients (1 male, 5 female; average age, 22.33 years) treated for confirmed MGCT between 2001 and 2015. The patients' clinical information, images from radiographs (n = 14), CT (n = 13), MRI (n = 8), bone scintigraphy (n = 1) and PET-CT (n = 2), as well as histologic features, treatment and prognosis were analyzed. A total of 17 lesions were detected: 4 around the knee joint, 3 in the greater trochanter and head of the femur, 5 in the small bones of the feet, and 2 in flat bones...
December 13, 2016: Oncotarget
https://www.readbyqxmd.com/read/27732330/severe-rebound-associated-vertebral-fractures-after-denosumab-discontinuation-9-clinical-cases-report
#18
Olivier Lamy, Elena Gonzalez-Rodriguez, Delphine Stoll, Didier Hans, Bérengère Aubry-Rozier
Context: Denosumab inhibits bone resorption, increases bone mineral density, and reduces fracture risk. Denosumab was approved for the treatment of osteoporosis and the prevention of bone loss in some oncological situations. Denosumab discontinuation is associated with a severe bone turnover rebound (BTR) and a rapid loss of bone mineral density. The clinical consequences of the BTR observed after denosumab discontinuation are not known. Cases Description: We report 9 women who presented 50 rebound-associated vertebral fractures (RAVFs) after denosumab discontinuation...
February 1, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/27263783/efficacy-and-safety-of-denosumab-in-multiple-myeloma
#19
Junichi Kitagawa, Yuhei Shibata, Takuro Matsumoto, Nobuhiko Nakamura, Hiroshi Nakamura, Soranobu Ninomiya, Yasuhito Nannya, Takeshi Hara, Hisashi Tsurumi
We analyzed 11 patients with multiple myeloma (MM) treated using denosumab in our institute. The median age was 69 years (range, 54-76 years), and 7 patients were male. Seven patients had presented with newly diagnosed MM. Four patients were initially treated with zoledronic acid, which was then later switched to denosumab. The median number of injections was 15 (range, 1-27). No patients developed skeletal-related events (SRE) during denosumab treatment. Hypocalcemia was defined as serum calcium levels below the baseline in all patients...
May 2016: [Rinshō Ketsueki] the Japanese Journal of Clinical Hematology
https://www.readbyqxmd.com/read/27172934/grand-4-the-german-retrospective-analysis-of-long-term-persistence-in-women-with-osteoporosis-treated-with-bisphosphonates-or-denosumab
#20
P Hadji, I Kyvernitakis, P H Kann, C Niedhart, L C Hofbauer, H Schwarz, A A Kurth, F Thomasius, M Schulte, M Intorcia, E Psachoulia, T Schmid
UNLABELLED: This retrospective database study assessed 2-year persistence with bisphosphonates or denosumab in a large German cohort of women with a first-time prescription for osteoporosis treatment. Compared with intravenous or oral bisphosphonates, 2-year persistence was 1.5-2 times higher and risk of discontinuation was significantly lower (P < 0.0001) with denosumab. INTRODUCTION: Persistence with osteoporosis therapies is critical for fracture risk reduction...
October 2016: Osteoporosis International
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