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Denosumab discontinue treatment

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...
January 31, 2017: Osteoporosis International
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...
January 20, 2017: Acta Oncologica
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
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
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
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
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