Article: article from journal or magazin.
Romosozumab Treatment in Postmenopausal Women with Osteoporosis.
The New England journal of medicine
Bado C, Bagur A, Gomez Acotto C, Maffei L, Massari F, Tate G, Ulla MR, Arya K, Clifton-Bligh R, Duncan E, Grill V, Kotowicz M, Roberts A, Seeman E, Geusens P, Gielen E, Goemaere S, Reginster J-Y, Rozenberg S, Witvrouw R, Aguiar C, Albergaria B-H, Castro M, Cunha Borges JL, de Gregorio LH, Hegg R, Radominski S, Zerbini CAF, Adachi J, Brown J, Grunbaum D, Hanley D, Kendler D, Khan A, Lau EMC, Leung P-C, Arteaga Diaz J, Casas Diaz N, Chalem Choueka MR, Cure Cure CA, Jaller Raad JJ, Perez Nino CA, Restrepo J, Molina JF, Restrepo Velez Sanchez PJ, Yupanqui Lozno H, Dokoupilova E, Hala T, Kasalicky P, Kucerova I, Machkova M, Novosad P, Pikner R, Ruzickova O, Senk F, Smajstrla V, Smejkalova O, Vyskocil V, Alexandersen P, Beck Jensen J-E, Hermann P, Langdahl B, Saetre Lihn A, Schmidt U, Schwarz P, Mejia De la Cruz DM, Paez Abadin NS, Velazco Espaillat MC, Maasalu K, Vahula K-L, Valter I, Contzen C, Frieling I, Hensen J, HimpelBönninghoff A-A, Hofbauer L, Lappo M, Maus O, Niedhart C, Piechatzek R, Rinke A, Stössel J, Balazs T, Horvath K, Kanakaridu E, Kiss I, Lakatos P, Valkusz Z, Agarwal R, Bandgar T, Paul T, Sancheti P, Shetty N, Sriram U, Amano K, Endo I, Esaki Y, Fujimori M, Fukagawa M, Fukuchi M, Hanashi H, Hatsumi T, Hidaka S, Ikeda N, Kataoka Y, Kikuno R, Kishikawa Y, Kozuma T, Maruta T, Matsue R, Miki Y, Misawa H, Miyauchi A, Miyazaki K, Miyoshi H, Mizuno S, Mori S, Nago M, Naito K, Nakayama M, Nakatsuchi Y, Nakayama S, Nemoto Y, Noguchi M, Omata M, Omura F, Onishi T, Ozawa Y, Sato T, Sekiguchi N, Sekiguchi Y, Shimamoto E, Shimizu H, Shimoda J, Shimogata M, Shimomura H, Shinto T, Somekawa Y, Sunayama C, Suzuki K, Takahashi M, Takeishi H, Tanaka A, Tanaka H, Tanaka M, Tomonaga A, Yokoyama T, Yoshida M, Andersone D, Kaze I, Medne A, Krasauskiene A, Radzeviciene-Jurgute R, Tamulaitiene M, Urboniene A, Visockiene Z, Elizondo Alanis LJ, Garcia Hernandez PA, Tamayo Y Orozco JA, Gilchrist N, Reid I, Blach E, Blicharski T, Cesarz M, Czerwinski E, Dabrowska M, Daniluk S, Franek E, Jendrych B, Korkosz M, Lorenc R, Plebanski R, Pluskiewicz W, Sewerynek E, Sidorowicz-Bialynicka A, Supronik J, SzyskaSkrobot D, Wiland P, Mologhianu G, Mustatea S, Tanaseanu CM, Triff CA, Vermesan H, Hawkins Carranza FG, Jodar Gimeno E, Malouf Sierra J, Palacios Gil-Antuñano S, Dudler J, Ferrari S, Frey-Strehler D, Lamy O, Lippuner K, Theiler R, Arif I, Deshpande M, Fiore G, Hawys T, Hristova D, Ivan P, Okily M, Oyesile B, Subramanian G, Binkley N, Bolognese M, Bone H, Bonnick S, Feldman R, Harris H, Hoekstra J, Kivitz A, Lane N, Lewiecki EM, Mandel D, Maricic M, McIlwain H, Miller P, Moffett A, Oates M, Recknor C, Sebba A, Vargo J, Weinstein R
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
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. The coprimary end points were the cumulative incidences of new vertebral fractures at 12 months and 24 months. Secondary end points included clinical (a composite of nonvertebral and symptomatic vertebral) and nonvertebral fractures. Results At 12 months, new vertebral fractures had occurred in 16 of 3321 patients (0.5%) in the romosozumab group, as compared with 59 of 3322 (1.8%) in the placebo group (representing a 73% lower risk with romosozumab; P<0.001). Clinical fractures had occurred in 58 of 3589 patients (1.6%) in the romosozumab group, as compared with 90 of 3591 (2.5%) in the placebo group (a 36% lower risk with romosozumab; P=0.008). Nonvertebral fractures had occurred in 56 of 3589 patients (1.6%) in the romosozumab group and in 75 of 3591 (2.1%) in the placebo group (P=0.10). At 24 months, the rates of vertebral fractures were significantly lower in the romosozumab group than in the placebo group after each group made the transition to denosumab (0.6% [21 of 3325 patients] in the romosozumab group vs. 2.5% [84 of 3327] in the placebo group, a 75% lower risk with romosozumab; P<0.001). Adverse events, including instances of hyperostosis, cardiovascular events, osteoarthritis, and cancer, appeared to be balanced between the groups. One atypical femoral fracture and two cases of osteonecrosis of the jaw were observed in the romosozumab group. Conclusions In postmenopausal women with osteoporosis, romosozumab was associated with a lower risk of vertebral fracture than placebo at 12 months and, after the transition to denosumab, at 24 months. The lower risk of clinical fracture that was seen with romosozumab was evident at 1 year. (Funded by Amgen and UCB Pharma; FRAME ClinicalTrials.gov number, NCT01575834 .).
Aged, Aged, 80 and over, Antibodies, Monoclonal/adverse effects, Antibodies, Monoclonal/therapeutic use, Biomarkers/analysis, Bone Density/drug effects, Bone Density Conservation Agents/adverse effects, Bone Density Conservation Agents/therapeutic use, Bone Remodeling/physiology, Denosumab/therapeutic use, Double-Blind Method, Female, Humans, Injections, Subcutaneous, Middle Aged, Osteoporosis, Postmenopausal/drug therapy, Spinal Fractures/epidemiology, Spinal Fractures/prevention & control
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