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Sven Otto, Egon Burian, Matthias Troeltzsch, Gabriele Kaeppler, Michael Ehrenfeld
PURPOSE: Diffuse sclerosing osteomyelitis (DSO) is a rare disease of the jaw bone. Its treatment is challenging. Different medical and surgical treatment protocols have been proposed; however, none of these treatment protocols produce reliable results. Recently, ibandronate administration has been attempted as a treatment alternative in acute cases of DSO. Due to the similar antiresorptive effect, we sought to explore the application of the human monoclonal antibody to the receptor activator of nuclear factor kappaB ligand (RANKL), denosumab, in the treatment of DSO...
April 2018: Journal of Cranio-maxillo-facial Surgery
Emma D Deeks
Denosumab (Prolia® ; Pralia® ) is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once every 6 months and is approved for various indications, including the treatment of postmenopausal (PM) women with osteoporosis at increased/high risk of fracture or failure/intolerance of other osteoporosis therapies (indications featured in this review). Denosumab showed benefit in several phase 3 or 4 studies in PM women with osteoporosis or low bone mineral density (BMD), including the pivotal 3-year double-blind FREEDOM trial and its 7-year open-label extension...
February 2018: Drugs & Aging
Kristie N Tu, Janette D Lie, Chew King Victoria Wan, Madison Cameron, Alaina G Austel, Jenny K Nguyen, Kevin Van, Diana Hyun
Approximately 10 million men and women in the U.S. have osteoporosis,1 a metabolic bone disease characterized by low bone density and deterioration of bone architecture that increase the risk of fractures.2 Osteoporosis-related fractures can increase pain, disability, nursing home placement, total health care costs, and mortality.3 The diagnosis of osteoporosis is primarily determined by measuring bone mineral density (BMD) using noninvasive dual-energy x-ray absorptiometry. Osteoporosis medications include bisphosphonates, receptor activator of nuclear factor kappa-B ligand inhibitors, estrogen agonists/antagonists, parathyroid hormone analogues, and calcitonin...
February 2018: P & T: a Peer-reviewed Journal for Formulary Management
S Migliaccio, D Francomano, E Romagnoli, C Marocco, R Fornari, G Resmini, A Buffa, G Di Pietro, S Corvaglia, F Gimigliano, A Moretti, A de Sire, N Malavolta, A Lenzi, E A Greco, G Iolascon
BACKGROUND: Persistence is commonly considered a key factor for the successful management of osteoporosis and fragility fractures. Denosumab is the first biologic agent developed for the treatment of osteoporosis with satisfying data regarding the persistence with this therapy. AIM: The purpose of this multicenter observational real practice study was to evaluate the persistence with denosumab treatment in post-menopausal women affected by osteoporosis. MATERIAL/SUBJECTS AND METHODS: Women were recruited in four specialized centers for the management of osteoporosis in North, Center and South of Italy...
December 2017: Journal of Endocrinological Investigation
S Malnick, Y Maor, E Melzer, N N Ziv-Sokolowskaia, M G Neuman
OBJECTIVE: Denosumab (Prolia, Amgen, Thousand Oaks, CA, USA) is a fully human antibody to the receptor activator of nuclear factor-KB ligand (RANKL). We present a case of submassive hepatic necrosis with evidence implicating cytokine induction resulting from an immune reaction to denosumab. CASE REPORT: A 72-year-old lady presented with elevated liver enzymes. One month previously, she received a s/c administration of 60 mg of denosumab. Viral hepatitis A, B and C and human herpes viruses 6-7 were negative as were routine autoimmune serology...
March 2017: European Review for Medical and Pharmacological Sciences
Smita Jha, Timothy Bhattacharyya
UNLABELLED: There is a strong impetus to prevent and treat osteoporosis to prevent fractures. $990 million dollars was spent on anti-osteoporosis drugs in 2013. As we shift our focus on primary prevention of fractures, providers are encouraged to find the most cost-effective anti-osteoporosis therapy for patients. PURPOSE: Osteoporosis is a major global problem with osteoporotic fractures posing a potentially avoidable burden on healthcare resources. We studied the utilization and cost of anti-osteoporotic therapy using the 2013 Medicare Part D data...
December 2016: Archives of Osteoporosis
C V Lyttle, H Patterson
A patient was referred by a clinical oncologist regarding a non-healing area of bone in the lower jaw. The patient was taking denosumab (Prolia(®), Xgeva(®)) when they had a tooth extracted and the area failed to heal. Following suspension of the drug, the area healed with mucosal coverage. This new class of drugs are being increasingly used as an alternative antiresorptive drug to bisphosphonates and are licenced in the UK for prevention of osteoporotic fractures and prevention of skeletal-related events (SREs) in patients with metastatic cancer...
June 24, 2016: British Dental Journal
(no author information available yet)
No proven efficacy in preventing osteoporotic fractures in men, but serious adverse effects including atypical fractures and symptomatic hypocalcaemia.
February 2016: Prescrire International
Harlene Kaur Sidhu
Most dental professionals will have, or will soon, encounter patients prescribed this novel alternative antiresorptive drug to bisphosphonates, denosumab (Prolia®, Xgeva®). Denosumab is licensed in the UK for the prevention of osteoporotic fractures in postmenopausal women and the prevention of skeletal-related events (SRE) in adults with bone metastases. The presence of osteonecrosis of the jaw in patients receiving non-bisphosphonate antiresorptives has led to the introduction of the term antiresorptive-related osteonecrosis of the jaw or ARONJ...
June 2015: Dental Update
Matthew Wong-Pack, Aashish Kalani, Jacob Hordyk, George Ioannidis, Robert Bensen, William G Bensen, Alexandra Papaioannou, Jonathan D Adachi, Arthur N Lau
Although denosumab (Prolia) has been shown to be a safe and efficacious therapy for osteoporotic patients in numerous clinical trials, few studies have determined its effectiveness in real world clinical practice. A retrospective review of patients prescribed Prolia assessing the impact that noncompliance from the regular dosing regimen of six months for denosumab has on bone mineral density (BMD) was performed. 924 patient records were reviewed between August 2012 and September 2013 with 436 patients meeting the eligibility criteria...
2016: Journal of Osteoporosis
T Geith, W Mutschler, F Berger
BACKGROUND: The bone marrow edema syndrome (BMES) is a painful joint disease which usually affects healthy middle aged persons. It is usually treated conservatively. AIM: This case report describes the clinical history of a patient with BMES and a therapy attempt with denosumab. RESULTS AND DISCUSSION: Complete restitution of the bone marrow edema in the knee and the disappearance of clinical complaints were observed 8 weeks after a single therapy with 60 mg denosumab (Prolia®) as a subcutaneous injection...
March 2015: Der Unfallchirurg
O B Ershova, O M Lesniak, K Iu Belova, A V Nazarova, A V Manovitskaia, T M Musaeva, R M Musraev, R Z Nurlygaianov, L Ia Rozhinskaia, I A Skripnikova, N V Toroptsova
AIM: To evaluate the efficacy and safety of Denosumab (Prolia), a first-line osteoporosis (OP) medication that is a fully human monoclonal antibody to the receptor activator of nuclear factor xB ligand (RANKL), within an open-label observational study. SUBJECTS AND METHODS: Patients aged 50 years or older with postmenopausal OP, who were treated with Prolia in clinical practice, were examined. The concentrations of the bone resorption (BR) marker of C-terminal telopeptide and other laboratory indicators (total serum calcium, total alkaline phosphatase, and creatinine) were measured following 3 months...
2014: Terapevticheskiĭ Arkhiv
Kellen C Sheedy, Maria I Camara, Pauline M Camacho
OBJECTIVE: Injectable osteoporosis drugs are increasing in popularity due to their efficacy and convenient administration. In this retrospective comparison of the two available treatments, denosumab (Prolia®) and zoledronic acid (ZA, Reclast®), we aimed to determine and compare the efficacy and tolerability of denosumab and ZA. METHODS: The charts of patients who received denosumab and ZA at Loyola Hospital were reviewed, and adverse events were noted. Of primary interest were myalgias, flu-like symptoms, back pain, and fractures...
March 2015: Endocrine Practice
Veena Hoffman, Fei Xue, Betsey Gardstein, Kathleen Skerry, Cathy W Critchlow, Cheryl Enger
PURPOSE: The goal of this study is to develop and validate an algorithm to identify Prolia(®) users within a health insurance claims database. METHODS: Patients with a denosumab-specific or nonspecific administration claim during the early period of Prolia availability in the USA (June 1, 2010 to March 31, 2012) were classified as definite, probable, possible, and nonusers of Prolia using an algorithm consisting of nine different components based on claims patterns consistent with Prolia use...
September 2014: Pharmacoepidemiology and Drug Safety
Lesley J Scott
Subcutaneous denosumab (Prolia(®) [USA, Europe]; Pralia(®) [Japan]) once every 6 months is indicated in several countries for the treatment of postmenopausal women with osteoporosis at increased or high risk for fractures (featured indication). In some countries, it is also indicated for use in postmenopausal women who have failed or are intolerant to other osteoporosis treatments. In several international, phase III trials (≤3 years' duration) involving more than 12,000 women with postmenopausal osteoporosis or low bone mineral density (BMD), including Asian studies, denosumab was an effective and generally well tolerated treatment...
July 2014: Drugs & Aging
Jane Burch, Stephen Rice, Huiqin Yang, Aileen Neilson, Lisa Stirk, Roger Francis, Paul Holloway, Peter Selby, Dawn Craig
BACKGROUND: There is currently no standard practice for the monitoring of patients receiving treatment for osteoporosis. Repeated dual-energy X-ray absorptiometry (DXA) is commonly used for monitoring treatment response, but it has its limitations. Bone turnover markers have advantages over DXA as they are non-invasive, relatively cheap and can detect changes in bone turnover rates earlier. However, they do have disadvantages, particularly high within- and between-patient variability...
February 2014: Health Technology Assessment: HTA
Fei Xue, Haijun Ma, Catherine Stehman-Breen, Christine Haller, Leonid Katz, Rachel B Wagman, Cathy W Critchlow
PURPOSE: To describe the rationale and methods for a prospective, open-cohort study assessing the long-term safety of Prolia(®) for treatment of postmenopausal osteoporosis (PMO) in postmarketing settings. METHODS: Data will be derived from United States Medicare, United Healthcare, and Nordic (Denmark, Sweden, Norway) national registries. Observation will begin on the date of first Prolia(®) regulatory approval (May 26, 2010) and continue for 10 years. Women with PMO will be identified by postmenopausal age, osteoporosis diagnosis, osteoporotic fracture, or osteoporosis treatment...
October 2013: Pharmacoepidemiology and Drug Safety
Stanley S Lefkowitz, Doris L Lefkowitz, Jeremy Kethley
BACKGROUND: Facioscapulohumeral muscular dystrophy (FSHD) is the 3(rd) most common form of muscular dystrophy. Effective treatments for any of the muscular dystrophies have yet to be realized. This report describes such a treatment. CASE REPORT: A 66 year old female was diagnosed with osteoporosis. She had been diagnosed with FSHD muscular dystrophy a number of years previously by both genetic and clinical studies. Following a 2 year course with Forteo for osteoporosis, she was given an injection of Denosumab (Prolia) to maintain her bone density...
2012: American Journal of Case Reports
J D Ringe, P Farahmand
Almost 50 % of osteoporosis (OP) patients discontinue bisphosphonate (BP) therapy within 1-2 years after the start of their treatment. Denosumab's longer dosing interval with its administration every 6 months (Q6M) as a subcutaneous (sc) injection might result in a better real-life treatment adherence and persistence than weekly or monthly oral BP treatment regimen. The objectives of this open, investigator-initiated, prospective, observational, single-center study were to evaluate adherence with denosumab 60 mg sc every 6 months (Q6M) (Prolia(®)) injections in osteoporotic patients in a routine clinical care setting and to describe whether positive feedback to OP patients based on measured bone mineral density (BMD) increases and good safety profile have an impact on patients' real-life adherence...
May 2014: Rheumatology International
Gretchen L Johnson
No abstract text is available yet for this article.
February 15, 2012: American Family Physician
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