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https://www.readbyqxmd.com/read/28428078/kinetic-reconstruction-reveals-time-dependent-effects-of-romosozumab-on-bone-formation-and-osteoblast-function-in-vertebral-cancellous-and-cortical-bone-in-cynomolgus-monkeys
#1
Rogely Waite Boyce, Qing-Tian Niu, Michael S Ominsky
Romosozumab, a humanized monoclonal sclerostin antibody under development for the treatment of osteoporosis, has a unique mechanism of action on bone-increasing bone formation and decreasing bone resorption. The effects on bone formation are transient, eliciting a rapid increase in bone formation that attenuates with continued treatment. Although bone formation attenuates, bone mineral density (BMD) continues to increase. To explore potential tissue-level mechanisms that could contribute to a progressive increase in spine BMD, we used kinetic reconstruction techniques to examine the effects of romosozumab on modeling and remodeling units in vertebral cancellous bone from adult cynomolgus monkeys administered romosozumab for 10 and 28weeks...
April 18, 2017: Bone
https://www.readbyqxmd.com/read/28286990/the-quest-for-new-drugs-to-prevent-osteoporosis-related-fractures
#2
REVIEW
T J de Villiers
There is a need for the development of new drugs to prevent osteoporosis-related fractures. Fractures are projected to increase and the present drugs have modest efficacy, significant side-effects and poor compliance. To illustrate the difficulties in the development of new drugs, the author reviews the fate of several drugs that have failed to gain regulatory approval. These drugs include arzoxifene, lasofoxifene, MK-5442, roncalceret and odanacatib. Romosozumab and abaloparatide are the only new drugs presently in phase-3 development...
April 2017: Climacteric: the Journal of the International Menopause Society
https://www.readbyqxmd.com/read/28246926/romosozumab-treatment-converts-trabecular-rods-into-trabecular-plates-in-male-cynomolgus-monkeys
#3
Jonathan B Matheny, Ashley M Torres, Michael S Ominsky, Christopher J Hernandez
Treatment with sclerostin antibody (romosozumab) increases bone formation while reducing bone resorption, leading to increases in bone volume and bone mineral density. Sclerostin antibody treatment may also provide beneficial changes in trabecular microarchitecture and strength that are not reflected in bone volume and density. Here we use three-dimensional dynamic histomorphometry to determine longitudinal changes in vertebral trabecular microarchitecture in adolescent male cynomolgus monkeys (4-5 years old) treated with sclerostin antibody...
February 28, 2017: Calcified Tissue International
https://www.readbyqxmd.com/read/28121505/romosozumab-treatment-in-postmenopausal-osteoporosis
#4
LETTER
Guido Kranenburg, Jonas W Bartstra, Pim A de Jong
No abstract text is available yet for this article.
January 26, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28121504/romosozumab-treatment-in-postmenopausal-osteoporosis
#5
LETTER
Felicia Cosman, Daria B Crittenden, Andreas Grauer
No abstract text is available yet for this article.
January 26, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28064540/romosozumab-for-the-treatment-of-osteoporosis
#6
Leonardo Bandeira, E Michael Lewiecki, John P Bilezikian
Sclerostin, a glycoprotein produced primarily by osteocytes, blocks the canonical Wnt signaling bone formation pathway. Romosozumab is a humanized monoclonal antibody to sclerostin that binds to sclerostin, permitting the engagement of Wnt ligands with their co-receptors, resulting in an increase in bone formation and bone mineral density (BMD). Clinical studies with romosozumab have shown dramatic improvements in BMD at the spine and hip. Romosozumab is associated with improvement in bone strength through mechanisms that include increases in bone formation and, different from classical osteoanabolic agents, suppression of bone resorption...
February 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28017957/-development-of-osteoporosis-drugs-the-past-the-present-and-the-future
#7
Shinya Tanaka
From 1990s to 2000s, new drugs for osteoporosis have been developed, and the bone metabolism researches have livened up. In those days, many a people gathered to the meeting from many countries, and the each booth of pharmaceutics was proud of its preeminence. The dedications by the society and its members have had osteoporosis diagnostics developed, the anchor drugs become prevalent, and the number of fractures reduced. Although the brilliant effects of Romosozumab and Abaloparatide were presented in the meeting held this year, the members had to accept the convergence state of new drug developments...
2017: Clinical Calcium
https://www.readbyqxmd.com/read/27960628/antibodies-to-watch-in-2017
#8
Janice M Reichert
Over 50 investigational monoclonal antibody (mAb) therapeutics are currently undergoing evaluation in late-stage clinical studies, which is expected to drive a trend toward first marketing approvals of at least 6-9 mAbs per year in the near-term. In the United States (US), a total of 6 and 9 mAbs were granted first approvals during 2014 and 2015, respectively; all these products are also approved in the European Union (EU). As of December 1, 2016, 6 mAbs (atezolizumab, olaratumab, reslizumab, ixekizumab, bezlotoxumab, oblitoxaximab) had been granted first approvals during 2016 in either the EU or US...
February 2017: MAbs
https://www.readbyqxmd.com/read/27865001/romosozumab-improves-bone-mass-and-strength-while-maintaining-bone-quality-in-ovariectomized-cynomolgus-monkeys
#9
Michael S Ominsky, Steven K Boyd, Aurore Varela, Jacquelin Jolette, Melanie Felx, Nancy Doyle, Nacera Mellal, Susan Y Smith, Kathrin Locher, Sabina Buntich, Ian Pyrah, Rogely W Boyce
Romosozumab (Romo), a humanized sclerostin antibody, is a bone-forming agent under development for treatment of osteoporosis. To examine the effects of Romo on bone quality, mature cynomolgus monkeys (cynos) were treated 4 months post- ovariectomy (OVX) with vehicle, 3 mg/kg, or 30 mg/kg Romo for 12 months, or with 30 mg/kg Romo for 6 months followed by vehicle for 6 months (30/0). Serum bone formation markers were increased by Romo during the first 6 months, corresponding to increased cancellous, endocortical, and periosteal bone formation in rib and iliac biopsies at months 3 and 6...
November 10, 2016: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
https://www.readbyqxmd.com/read/27811938/bone-romosozumab-getting-there-but-not-quite-yet
#10
Socrates E Papapoulos
No abstract text is available yet for this article.
December 2016: Nature Reviews. Endocrinology
https://www.readbyqxmd.com/read/27641143/romosozumab-treatment-in-postmenopausal-women-with-osteoporosis
#11
RANDOMIZED CONTROLLED TRIAL
Felicia Cosman, Daria B Crittenden, Jonathan D Adachi, Neil Binkley, Edward Czerwinski, Serge Ferrari, Lorenz C Hofbauer, Edith Lau, E Michael Lewiecki, Akimitsu Miyauchi, Cristiano A F Zerbini, Cassandra E Milmont, Li Chen, Judy Maddox, Paul D Meisner, Cesar Libanati, Andreas Grauer
BACKGROUND: Romosozumab, a monoclonal antibody that binds sclerostin, increases bone formation and decreases bone resorption. METHODS: We enrolled 7180 postmenopausal women who had a T score of -2.5 to -3.5 at the total hip or femoral neck. Patients were randomly assigned to receive subcutaneous injections of romosozumab (at a dose of 210 mg) or placebo monthly for 12 months; thereafter, patients in each group received denosumab for 12 months, at a dose of 60 mg, administered subcutaneously every 6 months...
October 20, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27569204/carcinogenicity-risk-assessment-of-romosozumab-a-review-of-scientific-weight-of-evidence-and-findings-in-a-rat-lifetime-pharmacology-study
#12
Luc Chouinard, Melanie Felx, Nacera Mellal, Aurora Varela, Peter Mann, Jacquelin Jolette, Rana Samadfam, Susan Y Smith, Kathrin Locher, Sabina Buntich, Michael S Ominsky, Ian Pyrah, Rogely Waite Boyce
Romosozumab is a humanized immunoglobulin G2 monoclonal antibody that binds and blocks the action of sclerostin, a protein secreted by the osteocyte and an extracellular inhibitor of canonical Wnt signaling. Blockade of sclerostin binding to low-density lipoprotein receptor-related proteins 5 and 6 (LRP5 and LRP6) allows Wnt ligands to activate canonical Wnt signaling in bone, increasing bone formation and decreasing bone resorption, making sclerostin an attractive target for osteoporosis therapy. Because romosozumab is a bone-forming agent and an activator of canonical Wnt signaling, questions have arisen regarding a potential carcinogenic risk...
November 2016: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/27510350/osteoporosis-treatment-a-missed-opportunity
#13
REVIEW
Frances Milat, Peter R Ebeling
Osteoporosis affects 1.2 million Australians and, in 2012, fractures due to osteoporosis and osteopenia in Australians aged over 50 years cost $2.75 billion. Even minor minimal trauma fractures are associated with increased morbidity and mortality. Despite increasing therapeutic options for managing osteoporosis, fewer than 20% of patients with a minimal trauma fracture are treated or investigated for osteoporosis, so under-treatment is extremely common. Fracture risk assessment is important for selecting patients who require specific anti-osteoporosis therapy...
August 15, 2016: Medical Journal of Australia
https://www.readbyqxmd.com/read/27487526/effects-of-romosozumab-compared-with-teriparatide-on-bone-density-and-mass-at-the-spine-and-hip-in-postmenopausal-women-with-low-bone-mass
#14
Harry K Genant, Klaus Engelke, Michael A Bolognese, Carlos Mautalen, Jacques P Brown, Chris Recknor, Stefan Goemaere, Thomas Fuerst, Yu-Ching Yang, Andreas Grauer, Cesar Libanati
Romosozumab, a monoclonal antibody that binds sclerostin, has a dual effect on bone by increasing bone formation and reducing bone resorption, and thus has favorable effects in both aspects of bone volume regulation. In a phase 2 study, romosozumab increased areal BMD at the lumbar spine and total hip as measured by DXA compared with placebo, alendronate, and teriparatide in postmenopausal women with low bone mass. In additional analyses from this international, randomized study, we now describe the effect of romosozumab on lumbar spine and hip volumetric BMD (vBMD) and BMC at month 12 as assessed by QCT in the subset of participants receiving placebo, s...
January 2017: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
https://www.readbyqxmd.com/read/26989807/new-horizons-in-osteoporosis-therapies
#15
REVIEW
Torben Harsløf, Bente L Langdahl
Efficient therapies are available for the treatment of osteoporosis, however, there are still unmet needs. Anti-resorptive therapies only increase bone mineral density to a certain extent and reduce the risk of non-vertebral fractures by 20%, only one anabolic option is available-the effect of which levels off over time, and the evidence for combination therapy targeting both resorption and formation is limited. The current review will focus on emerging treatments of osteoporosis with the potential of enhanced anabolic effects (romosozumab and abaloparatide) or uncoupling of resorption and formation (odanacatib and romosozumab) as well as the effect of combination therapy...
June 2016: Current Opinion in Pharmacology
https://www.readbyqxmd.com/read/26946704/-bone-diseases
#16
Brigitte Uebelhart, René Rizzoli
Calcium intake shows a small impact on bone mineral density and fracture risk. Denosumab is a more potent inhibitor of bone resorption than zoledronate. Abaloparatide, PTHrP analog, increases bone mineral density and decreases fracture incidence. Teriparatide could be delivered via a transdermic device. Romosozumab and odanacatib improve calculated bone strength. Sequential or combined treatments with denosumab and teriparatide could be of interest, but not denosumab followed by teriparatide. Fibrous dysplasia, Paget disease and hypophosphatasia are updated, as well as atypical femoral fracture and osteonecrosis of the jaw...
January 13, 2016: Revue Médicale Suisse
https://www.readbyqxmd.com/read/26768288/anti-sclerostin-is-there-an-indication
#17
Sune Larsson
Several decades ago, a clinical condition that included severe bone overgrowth was described in a few patients in South Africa. The autosomal-recessive disease that later was named sclerosteosis was found to be caused by a mutation in the SOTS gene causing a lack of the protein sclerostin. This protein is produced by osteocytes and exerts its effect as an inhibitor of bone formation by blocking the Wnt signaling pathway. By the use of a monoclonal antibody that can block sclerostin a novel therapeutic pathway for rebuilding bone has been described...
January 2016: Injury
https://www.readbyqxmd.com/read/26651519/antibodies-to-watch-in-2016
#18
Janice M Reichert
The number of novel antibody therapeutics that received first marketing approvals in 2015 met expectations, with 6 (alirocumab (Praluent®), evolocumab (Repatha®), daratumumab (Darzalex®), dinutuximab (Unituxin®), idarucizumab (Praxbind®), mepolizumab (Nucala®)) granted first approvals as of mid-November*. Seven novel antibody therapeutics (begelomab, brodalumab, elotuzumab, ixekizumab, necitumumab, obiltoxaximab, reslizumab) are in regulatory review, and thus a similar number, if not more, are projected to gain first approvals in 2016...
2016: MAbs
https://www.readbyqxmd.com/read/26557374/new-insights-into-treatment-of-osteoporosis-in-postmenopausal-women
#19
REVIEW
Piet Geusens
For the prevention of fractures, antiresorptive drugs (bisphosphonates and denosumab) that decrease high bone resorption and, secondarily, also bone formation, are the mainstream of therapy. Osteoanabolic drugs, such as teriparatide, increase bone formation more than bone resorption, and are used in severe osteoporosis, including patients treated with antiresorptive drugs who still lose bone and have recurrent fractures. New potential drugs for fracture prevention that uncouple bone resorption from bone formation include odanacatib, a specific inhibitor of cathepsin-K, the enzyme that degrades bone collagen type I, that inhibits bone resorption and only temporarily bone formation, and monoclonal antibodies against sclerostin (romosozumab, blosozumab), that stimulate bone formation and decrease bone resorption...
2015: RMD Open
https://www.readbyqxmd.com/read/26529924/-pharmacology-of-bone-anabolic-agents
#20
Toshio Matsumoto
Bone is constantly remodeled to maintain its volume, structural integrity and strength Currently available bone anabolic agent is teriparatide. Teriparatide increases bone mass and strength via both remodeling-dependent and -independent mechanisms, although remodeling-dependent mechanism overweighs the other. Canonical Wnt signal plays an important role in enhancing osteoblast differentiation and bone formation, and its osteocyte-derived inhibitor, sclerostin, regulates bone formation via the regulation of Wnt signaling...
October 2015: Nihon Rinsho. Japanese Journal of Clinical Medicine
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