دورية أكاديمية
Odanacatib for the treatment of postmenopausal osteoporosis. results of the LOFT multicentre, randomised, double-blind, placebo-controlled trial and LOFT extension study
| العنوان: | Odanacatib for the treatment of postmenopausal osteoporosis. results of the LOFT multicentre, randomised, double-blind, placebo-controlled trial and LOFT extension study |
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| المؤلفون: | McClung M. R., O'Donoghue M. L., Papapoulos S. E., Bone H., Langdahl B., Saag K. G., Reid I. R., Kiel D. P., Cavallari I., Bonaca M. P., Wiviott S. D., de Villiers T., Ling X., Lippuner K., Nakamura T., Reginster J. -Y., Rodriguez-Portales J. A., Roux C., Zanchetta J., Zerbini C. A. F., Park J. -G., Im K., Cange A., Grip L. T., Heyden N., DaSilva C., Cohn D., Massaad R., Scott B. B., Verbruggen N., Gurner D., Miller D. L., Blair M. L., Polis A. B., Stoch S. A., Santora A., Lombardi A., Leung A. T., Kaufman K. D., Sabatine M. S., Mautalen C. A., Man Z., Zanchetta J. R., Magaril C. H., Sambrook P., Geusens P., Goemaere S., Albergaria B. H., Zerbini C. A. D. F., Castro M. L., Gregorio L. H., Stoilov R., Borissova A. -M. I., Hristozov K. H., Temelkova N. L., Daskalova I. K., Kuzmanova S. I., Yaneva-Bichovska D., Batalov A. Z., Riedemann P., Rodriguez Portales J. A., Tang H., Zhu H., Zhang Z., Chao A., Hu Y., Liu Z., Lu J., Qiu M., Gao X., Zhang S., Xu L., Xia W., Liao E., Yang W., Wu W., Dai K., Hu R., Jaller J. J., Cabal F., Molina J. F., Cure Cure C. A., Yupanqui-Lozno H., Chalem P., Londono J., Abello M., Tobias E. D., Otero W., Nikolic T., Miskic B., Stepan J., Vyskocil V., Novosad L., Slesinger J., Novosad P., Vlckova E., Bortlik L., Dokoupilova E., Hala T., Jensen J. -E. B., Brixen K. T., Langdahl B. L., Schwarz P., Eskildsen P. C., Eiken P. A., Hermann A. P., Gram J., Schou M. B., Alexandersen P., Nedergaard B., Mejia D. M., Estrella De Henriquez L., Paez N., Velazco C., Valter I., Vahula K. -L., Kull I., Maasalu K., Chapurlat R., Fardellone P., Benhamou C. L., Weryha G., Herkt V., Martz R., Nischik R., Spieler W., Contzen C., Felsenberg D., Frieling I., Frahm E., Briones H., Sandoval B., Barrios P., Garcia A., Avendano C., Gonzalez M., Guerra J., Tuna M., Diaz O. M., Samayoa E., Lopez E., Barrera J. R., Palencia M., Cifuentes M., Alvarado G., Lopez M., Chavez N., Haase F., Rivera R., Gonzalez C., Tan K., Leung P. C., Mandalam S., Pitale S. U., Bantwal G., Ammini A. C., Shaikh S. S. A., Kanakatte Mylariah P. K., Dharmalingam M., Mukhopadhyay S., Jain A., Singh P., Shetty N., Sathyanarayana S. S., Shah N., Chadha M. D., Bhandankar R., Velayutham K., Marwah S., John M., Sahay R. K., Adami S., Nuti R., Bianchi G., Brandi M. L., Minisola S., Fiore C. E., Rubinacci A., Miyajima H., Yamane H., Nakatani Y., Okamoto S., Kuroda K., Fujimori M., Itabashi A., Katayama K., Nakajo S., Somekawa Y., Ohsawa Y., Tajima W., Mizuno K., Mori S., Kanabuchi T., Hashizume H., Oka N., Hamada K., Yamaguchi M., Hirahara F., Atobe M., Ohtake Y., Ichikawa S., Onishi T., Matsumoto K., Shirasawa E., Takahashi M., Oguma T., Matsui H., Katoh Y., Shigenobu K., Shibukawa M., Ikeda S., Osaka K., Kanda R., Inobe Y., Shigenobu M., Hasegawa M., Yamaji T., Miyazaki Y., Ito T., Nakamura E., Nagai S., Lim S. -K., Chung Y. -S., Shin C. -S., Min Y. -K., Kim G. S., Yoon H. K., Kang M. -I., Yang K. -H., Park H. M., Kim I. J., Chung D. J., Chung H. Y., Jaundzeikare S., Andersone D., Medne A., Yaghi Y., Alekna V., Kasiulevicius V., Purtokaite - Labutiniene I., Krasauskiene A., Varanaviciene J., Basijokiene V., Abraitiene A., Radzeviciene L., Walliser J., Garcia Hernandez P. A., Araujo M. F., Avila Armengol H. E., De la Pena P., Tamayo J., Zazueta B., Cons F., Gilchrist N. L., Leikis R., Jones P., Singh J. G. P., Halse J. I., Syversen U., Hoivik H. O., Ofjord E. S., Gulseth H. C., Elle S., Norheim P. D., Calvo Quiroz A. A., Cesar Augusto P. A., Leon Portocarrero M. G., Vidal Neira L. F., Chavez J., Garro Barrera B., Kuroiwa Sampei R., Luis Fernando B. V., Oquelis Cabredo R., Castillo S., Morales A. M. G., Tan P. P., Leagogo L. A. C., Wang E. H., Li-Yu J. T., Sawicki A. Z., Stasiuk B., Kania G., Lorenc R., Sidorowicz-Bialynicka A., Szczepanski L., Franek E., Filip R., Sekula J., Blicharski T., Leszczynski P., Sewerynek E., Miazgowski T., Milewicz A., Dabrowska M., Romaszko J., Pluskiewicz W., Wojnowski L., Codreanu C., Bolosiu H., Ionescu R., Zosin I., Macovei L., Bojinca M., Radulescu F., Pop S., Sarbu A., Benevolenskaya L. I., Nasonov E. L., Rozhinskaya L. Y., Oganov R. G., Rodionova S. S., Shlyakhto E. V., Trofimov V., Zotkin E. G., Zazerskaya I. E., Grineva E. N., Ershova O., Lesnyak O., Ostroumova O. D., Malichenko S. B., Pikhlak E. G., Pilyaev V. G., Raskina T., Zonova E. V., Shirinsky V. S., Dimic A. N., Cobeljic G., Vujovic S., Ellis G. C., Lipschitz S., De Villiers T. J., De Weerd A. J., Vally T., Trinder Y., Coetsee J. L., Davis C. P., Nayiager S., Hough F. S., Oelofse L. F., van der Walt E., Lombaard J. J., Blignaut S., Govind U., Fouche L. F., Kruger D. S., Dalmeyer J. P., Ferreira M. M., Escudero-Contreras A., Munoz Torres M., Hawkins Carranza F., Perez Castrillon J. L., Garcia Meijide J. A., Jodar Gimeno E., Palacios Gil-Antunana S., de Teresa Parreno L., Martin Mola E., Alvarez Sanchez C., Tsai K. -S., Tu S. -T., Chen J. -F., Lee O. K. -S., Hsu W. -W., Grygorieva N. V., Povoroznyuk V. V., Korzh M. O., Loskutov O. L., Chukov A. B., Sarmiento R., Thomas H., Donnachie H., Pavel-Knox I., Shaw H., Hassanin H., Abdulhakim E. E. A., Savani N., Bachmann G. A., Barrett-Connor E., Binkley N. C., Bone H. G., Brandon D. M., Checketts D. D., Fraser N. J., Watts N. B., Geller S. A., Gimbel J. S., Greenwald M. W., Holt P. A., Johnston C. C., Fang C., Klashman D. J., Lewiecki E. M., Lowenstein M. B., Nattrass S. M., Odio A., Levengood J., Romaguera J., Sebai M. B., Snyder B., Kutner M. E., Streja D., Schwartz E. P., Christiansen M. G. |
| المساهمون: | Mcclung, M. R., O'Donoghue, M. L., Papapoulos, S. E., Bone, H., Langdahl, B., Saag, K. G., Reid, I. R., Kiel, D. P., Cavallari, I., Bonaca, M. P., Wiviott, S. D., de Villiers, T., Ling, X., Lippuner, K., Nakamura, T., Reginster, J. -Y., Rodriguez-Portales, J. A., Roux, C., Zanchetta, J., Zerbini, C. A. F., Park, J. -G., Im, K., Cange, A., Grip, L. T., Heyden, N., Dasilva, C., Cohn, D., Massaad, R., Scott, B. B., Verbruggen, N., Gurner, D., Miller, D. L., Blair, M. L., Polis, A. B., Stoch, S. A., Santora, A., Lombardi, A., Leung, A. T., Kaufman, K. D., Sabatine, M. S., Mautalen, C. A., Man, Z., Zanchetta, J. R., Magaril, C. H., Sambrook, P., Geusens, P., Goemaere, S., Albergaria, B. H., Zerbini, C. A. D. F., Castro, M. L., Gregorio, L. H., Stoilov, R., Borissova, A. -M. I., Hristozov, K. H., Temelkova, N. L., Daskalova, I. K., Kuzmanova, S. I., Yaneva-Bichovska, D., Batalov, A. Z., Riedemann, P., Rodriguez Portales, J. A., Tang, H., Zhu, H., Zhang, Z., Chao, A., Hu, Y., Liu, Z., Lu, J., Qiu, M., Gao, X., Zhang, S., Xu, L., Xia, W., Liao, E., Yang, W., Wu, W., Dai, K., Hu, R., Jaller, J. J., Cabal, F., Molina, J. F., Cure Cure, C. A., Yupanqui-Lozno, H., Chalem, P., Londono, J., Abello, M., Tobias, E. D., Otero, W., Nikolic, T., Miskic, B., Stepan, J., Vyskocil, V., Novosad, L., Slesinger, J., Novosad, P., Vlckova, E., Bortlik, L., Dokoupilova, E., Hala, T., Jensen, J. -E. B. |
| بيانات النشر: | Elsevier Ltd. |
| سنة النشر: | 2019 |
| المجموعة: | Sapienza Università di Roma: CINECA IRIS |
| مصطلحات موضوعية: | cathepsin-k inhibitor, bone ma, women, strength, fracture, mortality, denosumab, turnover, therapy, density |
| الوصف: | Background: Odanacatib, a cathepsin K inhibitor, reduces bone resorption while maintaining bone formation. Previous work has shown that odanacatib increases bone mineral density in postmenopausal women with low bone mass. We aimed to investigate the efficacy and safety of odanacatib to reduce fracture risk in postmenopausal women with osteoporosis. Methods: The Long-term Odanacatib Fracture Trial (LOFT) was a multicentre, randomised, double-blind, placebo-controlled, event-driven study at 388 outpatient clinics in 40 countries. Eligible participants were women aged at least 65 years who were postmenopausal for 5 years or more, with a femoral neck or total hip bone mineral density T-score between −2·5 and −4·0 if no previous radiographic vertebral fracture, or between −1·5 and −4·0 with a previous vertebral fracture. Women with a previous hip fracture, more than one vertebral fracture, or a T-score of less than −4·0 at the total hip or femoral neck were not eligible unless they were unable or unwilling to use approved osteoporosis treatment. Participants were randomly assigned (1:1) to either oral odanacatib (50 mg once per week) or matching placebo. Randomisation was done using an interactive voice recognition system after stratification for previous radiographic vertebral fracture, and treatment was masked to study participants, investigators and their staff, and sponsor personnel. If the study completed before 5 years of double-blind treatment, consenting participants could enrol in a double-blind extension study (LOFT Extension), continuing their original treatment assignment for up to 5 years from randomisation. Primary endpoints were incidence of vertebral fractures as assessed using radiographs collected at baseline, 6 and 12 months, yearly, and at final study visit in participants for whom evaluable radiograph images were available at baseline and at least one other timepoint, and hip and non-vertebral fractures adjudicated as being a result of osteoporosis as assessed by clinical history and radiograph. ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/31676222; info:eu-repo/semantics/altIdentifier/wos/WOS:000497977100011; volume:7; issue:12; firstpage:899; lastpage:911; numberofpages:13; journal:THE LANCET DIABETES & ENDOCRINOLOGY; http://hdl.handle.net/11573/1400999Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85075142392 |
| DOI: | 10.1016/S2213-8587(19)30346-8 |
| الإتاحة: | https://doi.org/10.1016/S2213-8587Test(19)30346-8 http://hdl.handle.net/11573/1400999Test |
| حقوق: | info:eu-repo/semantics/closedAccess |
| رقم الانضمام: | edsbas.FED2B954 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/S2213-8587(19)30346-8 |
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