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Denosumab discontinue treatment

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...
November 3, 2016: Oncotarget
Olivier Lamy, Elena Gonzalez-Rodriguez, Delphine Stoll, Didier Hans, Bérengère Aubry-Rozier
CONTEXT: Denosumab inhibits bone resorption, increases bone mineral density (BMD), and reduces fracture risk. Denosumab was approved for the treatment of osteoporosis and the prevention of bone loss in some oncologic situations. Denosumab discontinuation is associated with a severe bone turnover rebound (BTR) and a rapid loss of BMD. 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...
October 12, 2016: Journal of Clinical Endocrinology and Metabolism
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
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
A S Koldkjær Sølling, T Harsløf, A Kaal, L Rejnmark, B Langdahl
UNLABELLED: Denosumab is used for treatment of osteoporosis. We present a case report of hypoparathyroid hypercalcemia and increased bone turnover associated with discontinuation of treatment for 10 years with denosumab. There is a need for evidence-based guidelines on discontinuation of long-term denosumab treatment to avoid side effects and preserving anti-fracture efficacy. PURPOSE: Denosumab is commonly used as an anti-resorptive agent for the treatment of osteoporosis...
July 2016: Osteoporosis International
Jordan C Villa, Arianna Gianakos, Joseph M Lane
BACKGROUND: Bisphosphonates are the most widely used treatment for osteoporosis. They accumulate in the bone for years, and therefore, their inhibitory effects on osteoclasts may persist after drug discontinuation. The ideal duration of therapy remains controversial. QUESTIONS/PURPOSES: The purpose of this study is to review the literature to determine the (1) indications for drug holiday, (2) the duration of drug holiday, (3) the evaluation during drug holiday, and (4) the proper treatment and maintenance after drug holiday...
February 2016: HSS Journal: the Musculoskeletal Journal of Hospital for Special Surgery
Dennis M Black, Clifford J Rosen
Key Clinical Points Postmenopausal Osteoporosis Fractures and osteoporosis are common, particularly among older women, and hip fractures can be devastating. Treatment is generally recommended in postmenopausal women who have a bone mineral density T score of -2.5 or less, a history of spine or hip fracture, or a Fracture Risk Assessment Tool (FRAX) score indicating increased fracture risk. Bisphosphonates (generic) and denosumab reduce the risk of hip, nonvertebral, and vertebral fractures; bisphosphonates are commonly used as first-line treatment in women who do not have contraindications...
January 21, 2016: New England Journal of Medicine
Silva Ottanelli
It is well known that fractures increase the risk of morbidity and mortality. The various mechanisms responsible for bone loss in cancer patients may have a different impact depending on the characteristics of the clinical case and correlates with the therapies used, or caused by the therapies used against cancer. Some hormonal treatments cause hypogonadism, event which contributes to the progressive loss of bone mass. This is detectable in patients with breast cancer receiving determines that estrogen-deprivation and in men with prostate cancer with therapies that determine androgen deprivation...
May 2015: Clinical Cases in Mineral and Bone Metabolism
B Aubry-Rozier, E Gonzalez-Rodriguez, D Stoll, O Lamy
Osteoporosis treatments are usually given for a limited period of time in order to balance benefits and risks. We report three cases of postmenopausal women without any previous fragility fracture who presented severe spontaneous vertebral fractures after denosumab discontinuation. We think that the occurrence of these fractures could be explained by the severe rebound effect observed after denosumab discontinuation and that a consensus regarding the end of treatment with denosumab has to be defined.
May 2016: Osteoporosis International
Lung-I Cheng, Emily Durden, Brendan Limone, Larry Radbill, Paul L Juneau, Leslie Spangler, Faisal M Mirza, Bradley S Stolshek
BACKGROUND: Prior research has shown that rates of persistence and compliance with osteoporosis therapies are associated with significantly fewer vertebral, nonvertebral, and hip fractures. A number of studies have examined medication-taking behavior with oral bisphosphonates and teriparatide, and these 1-year persistence rates have ranged from 39.9% to 56.7%. Limited real-world data are available regarding persistence and compliance rates with newer therapies such as denosumab, a RANK ligand inhibitor administered every 6 months as a subcutaneous injection...
September 2015: Journal of Managed Care & Specialty Pharmacy
Michael P Jeremiah, Brian K Unwin, Mark H Greenawald, Vincent E Casiano
Osteoporosis-related fractures affect approximately one in two white women and one in five white men in their lifetime. The impact of fractures includes loss of function, significant costs, and increased mortality. The U.S. Preventive Services Task Force recommends using dual energy x-ray absorptiometry to screen all women 65 years and older, and younger women who have an increased fracture risk as determined by the World Health Organization's FRAX Fracture Risk Assessment Tool. Although guidelines are lacking for rescreening women who have normal bone mineral density on initial screening, intervals of at least four years appear safe...
August 15, 2015: American Family Physician
Javier A Neyra, Natalia A Rocha, Rhea Bhargava, Omkar U Vaidya, Allen R Hendricks, Aylin R Rodan
BACKGROUND: Denosumab and abiraterone were approved by the United States Food and Drug Administration in 2011 for the treatment of metastatic castration-resistant prostate cancer. Neither denosumab nor abiraterone is known to cause rhabdomyolysis. CASE PRESENTATION: A 76-year-old Caucasian man with metastatic prostate cancer presented with non-oliguric severe acute kidney injury (AKI) 3 weeks after receiving simultaneous therapy with denosumab and abiraterone. The patient had been on statin therapy for more than 1 year with no recent dose adjustments...
2015: BMC Nephrology
S Papapoulos, K Lippuner, C Roux, C J F Lin, D L Kendler, E M Lewiecki, M L Brandi, E Czerwiński, E Franek, P Lakatos, C Mautalen, S Minisola, J Y Reginster, S Jensen, N S Daizadeh, A Wang, M Gavin, C Libanati, R B Wagman, H G Bone
UNLABELLED: The FREEDOM study and its Extension provide long-term information about the effects of denosumab for the treatment of postmenopausal osteoporosis. Treatment for up to 8 years was associated with persistent reduction of bone turnover, continued increases in bone mineral density, low fracture incidence, and a favorable benefit/risk profile. INTRODUCTION: This study aims to report the results through year 5 of the FREEDOM Extension study, representing up to 8 years of continued denosumab treatment in postmenopausal women with osteoporosis...
December 2015: Osteoporosis International
Yutaka Okagawa, Yasushi Sato, Hiroyuki Onuma, Takahiro Osuga, Tsuyoshi Hayashi, Tsutomu Sato, Koji Miyanishi, Masayoshi Kobune, Rishu Takimoto, Junji Kato
A 60s-year-old woman with metastatic colorectal cancer was treated using mFOLFOX6 plus bevacizumab. Zoledronic acid was also administered owing to the presence of bone metastasis. The patient was admitted to our hospital with progressive hypokalemia, hypocalcemia, hypophosphatemia, and proximal renal tubular dysfunction. A diagnosis of Fanconi syndrome was made, and was believed to be induced by zoledronic acid treatment. This treatment was discontinued, and the patient's renal tubular function recovered. Denosumab was subsequently administered to treat the bone metastasis, and no renal tubular dysfunction occurred...
July 2015: Gan to Kagaku Ryoho. Cancer & Chemotherapy
Benjamin Z Leder, Joy N Tsai, Alexander V Uihlein, Paul M Wallace, Hang Lee, Robert M Neer, Sherri-Ann M Burnett-Bowie
BACKGROUND: Unlike most chronic diseases, osteoporosis treatments are generally limited to a single drug at a fixed dose and frequency. Nonetheless, no approved therapy is able to restore skeletal integrity in most osteoporotic patients and the long-term use of osteoporosis drugs is controversial. Thus, many patients are treated with the sequential use of two or more therapies. The DATA study showed that combined teriparatide and denosumab increased bone mineral density more than either drug alone...
September 19, 2015: Lancet
George Michalopoulos, Spyridon Vrakas, Konstantinos Makris, Charalampos Tzathas
Coexistence of Crohn's disease (CD) and idiopathic systemic lupus erythematosus (SLE) is very rare. On the other hand, drug-induced lupus erythematosus (DILE) due to anti-tumor necrosis factor (TNF) agents is a relatively more common entity. DILE due to anti-TNF agents and idiopathic SLE share common serologic and epidemiologic characteristics making the differentiation between those two entities difficult. We present a case of a 35-year-old woman with CD who developed SLE after treatment with adalimumab and denosumab and persisting symptoms eight months after discontinuation of those agents...
July 2015: Annals of Gastroenterology: Quarterly Publication of the Hellenic Society of Gastroenterology
Nokitaka Setsu, Eisuke Kobayashi, Naofumi Asano, Naoko Yasui, Hiroshi Kawamoto, Akira Kawai, Keisuke Horiuchi
A 10-year-old boy diagnosed with unresectable giant cell tumor of bone in the sacrum was treated with a bone modifying agent denosumab. Administration of denosumab showed excellent clinical response without any major complications, and the tumor was surgically removed afterwards. However, 4 months after discontinuing denosumab, the patient developed severe hypercalcemia (15.2 mg/dl). There was a sharp surge in the levels of bone resorption markers, indicating that disregulated overt bone resorption after the discontinuation of denosumab led to hypercalcemia...
January 2016: Journal of Bone and Mineral Metabolism
Emma M Clark, Darshana Durup
Inflammatory eye reactions (IERs) are rare but have been associated with medications to treat osteoporosis. The aim of this review is to summarize the current literature on the association between IERs and specific medications to treat osteoporosis (bisphosphonates, selective estrogen receptor modulators, strontium, denosumab and teriparatide). We cover the known epidemiology, potential pathogenic mechanisms and a resume of unanswered questions. Briefly, this review highlights that none of the existing randomized clinical trials were powered to identify these rare adverse events, and the majority of the information available is from spontaneous case reports and case series reporting associations between bisphosphonates and IERs...
February 2015: Therapeutic Advances in Musculoskeletal Disease
Sarah Zaheer, Meryl LeBoff, E Michael Lewiecki
INTRODUCTION: Low trauma fractures due to osteoporosis are a major health concern worldwide. Despite the availability of many therapeutic compounds to reduce fracture risk, osteoporosis remains undertreated and the burden of osteoporotic fractures remains high. Denosumab is a novel agent that acts to reduce bone turnover, improve bone mineral density, and reduce fracture risk, offering a favorable efficacy and safety profile. AREAS COVERED: This review covers the pharmacology and major clinical trials with extension/post-marketing follow-up, including trials for all FDA-approved indications of denosumab to date...
March 2015: Expert Opinion on Drug Metabolism & Toxicology
Nathan Gossai, Megan V Hilgers, Lynda E Polgreen, Emily G Greengard
We report a 14 year-old female with Giant Cell Tumor of Bone, successfully treated with denosumab, who developed critical hypercalcemia after completion of therapy. Five months after her last denosumab treatment, serum calcium rose to 16.5 mg/dL (normal 8.7-10.8 mg/dL), nearly double her prior level of 8.4 mg/dL while receiving denosumab. She required emergent intervention to treat her hypercalcemia, which was attributed to rebound osteoclast activity and osteopetrotic bone. Denosumab is widely used in adults and increasingly in pediatric oncology populations and our experience demonstrates the need for close monitoring for electrolyte derangements following discontinuation...
June 2015: Pediatric Blood & Cancer
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