Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
28 febbraio 2013 aggiornato da: Pfizer
Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women
The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
7609
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Provincia de Buenos Aires, Argentina
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Herston, Australia, QLD 4029
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Keswick, Australia
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New South Wales
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Concord, New South Wales, Australia, 2139
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St Leonards, New South Wales, Australia, 2065
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Western Australia
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Nedlands, Western Australia, Australia, 6009
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Graz, Austria, 8036
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Diepenbeek, Belgio, 3590
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Genk, Belgio, 3600
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Gent, Belgio, 9000
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Leuven, Belgio, 3000
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Liege, Belgio, 4000
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Schiepsebos, Belgio, 6
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GO
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Goiania, GO, Brasile, 74175-080
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MT
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Duque de Caxias - Cuiaba, MT, Brasile, 78043-306
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RJ
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Rio de Janeiro, RJ, Brasile, 22271-100
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Rio de Janeiro, RJ, Brasile, 20020-020
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SP
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São Paulo, SP, Brasile, 04020-060
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Sao Paulo
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Sorocaba, Sao Paulo, Brasile, 18095-450
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4002
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Sofia, Bulgaria, 1504
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Sofia, Bulgaria, 1431
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Sofia, Bulgaria, 1407
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Sofia, Bulgaria, 1301
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Sofia, Bulgaria, 1303
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Quebec, Canada, G1S 2L6
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Quebec, Canada, G1V 3M7
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3X8
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1M3
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Ontario
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Hamilton, Ontario, Canada, L8N 1Y2
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Hawkesbury, Ontario, Canada, K6A 1A1
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Hawkesbury, Ontario, Canada, K6A 3B2
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London, Ontario, Canada, N6A 4V2
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Toronto, Ontario, Canada, M5C 2T2
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Toronto, Ontario, Canada, M5C 1R6
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Toronto, Ontario, Canada, M5G 1E2
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Toronto, Ontario, Canada, MB5 1W8
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Quebec
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Gatineau, Quebec, Canada, J8Y 6S9
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Montreal, Quebec, Canada, H2X 1N8
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Montreal, Quebec, Canada, H2L 1S6
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Pointe-Claire, Quebec, Canada, H9R 4S3
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Sherbrooke, Quebec, Canada, J1H 4J6
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Trois-Rivieres, Quebec, Canada, G8Z 1Y2
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 0H6
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Saskatoon, Saskatchewan, Canada, S7K 1N4
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Santiago, Chile
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Zadar, Croazia, 23000
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Zagreb, Croazia, 10000
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Aalborg, Danimarca, 9000
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Ballerup, Danimarca, 2750
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Vejle, Danimarca, 7100
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Tallinn, Estonia, 10128
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Tartu, Estonia, 50410
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Tartu, Estonia
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Tartu, Estonia, 51010
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Moscow, Federazione Russa, 115522
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Moscow, Federazione Russa, 119002
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Moscow, Federazione Russa, 117036
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Moscow, Federazione Russa, 101990
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Moscow, Federazione Russa, 107014
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Moscow, Federazione Russa, 121356
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Moscow, Federazione Russa, 127299
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Moscow, Federazione Russa, 129010
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Saint Petersburg, Federazione Russa, 190068
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St Petersburg, Federazione Russa, 194291
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St. Petersburg, Federazione Russa, 199034
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St. Petersburg, Federazione Russa, 1190068
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St. Petersburg, Federazione Russa, 190068
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Jyvaskyla, Finlandia, FIN-40100
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Jyväskylä, Finlandia, 40700
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Kuopio, Finlandia, 70210
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Kuopio, Finlandia, 70211
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Kuopio, Finlandia, FIN-70211
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Lahti, Finlandia
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Oulu, Finlandia, 90 100
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Turku, Finlandia, 20100
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FIN
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Jyvaskyla, FIN, Finlandia, 40100
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Lyon Cedex 03, Francia, 69437
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Orleans cedex 1, Francia, 45032
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Paris, Francia, 75015
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Berlin, Germania, 12200
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Muenchen, Germania, 80809
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Zerbst, Germania, 39261
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Athens, Grecia, 11526
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Hong Kong, Hong Kong
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PRC, Hong Kong
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Sai Ying Pung, Hong Kong
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Roma, Italia, 00168
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Roma, Italia, 00189
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Roma, Italia, 00136
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Siena, Italia, 53100
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Kaunas, Lituania, LT-50009
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Vilnius, Lituania, LT-10318
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Vilnius, Lituania, LT-04130
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Mexico City, Messico, 03100
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Mexico D.F., Messico, 11800
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Estado de Mexico
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seccion de Lomas Verdes, Estado de Mexico, Messico, CP 53120
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Bergen, Norvegia, NO-5094
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Hamar, Norvegia, 2317
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Oslo, Norvegia, NO-0164
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Oslo, Norvegia, NO-0176
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Trondheim, Norvegia, 7006
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Trondheim, Norvegia, NO-7006
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Auckland, Nuova Zelanda
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Dunedin, Nuova Zelanda
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Auckland
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Milford, Auckland, Nuova Zelanda
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NZ
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Christchurch, NZ, Nuova Zelanda, 8143
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Eindhoven, Olanda, 5611 NJ
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Rotterdam, Olanda, 3001 HG
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Dr
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Emmen, Dr, Olanda, 7824 AA
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GA
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Nijmegen, GA, Olanda, 6525
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HV
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Amsterdam, HV, Olanda, 1081
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SZ
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Nijmegen, SZ, Olanda, 6532
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Katowice, Polonia, 40-084
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Krakow, Polonia, 30-017
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Krakow, Polonia, 31-501
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Krakow, Polonia, 30-007
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Krakow, Polonia, 30-224
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Krakow, Polonia, 30-510
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Lublin, Polonia, 20-090
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Warszawa, Polonia, 00-909
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Warszawa, Polonia, 02-341
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Warszawa, Polonia, 04-730
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Warszawa, Polonia, 00-315
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Warszawa, Polonia, 00-418
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Warszawa, Polonia, 00-655
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Warszawa, Polonia, 00-699
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Warszawa, Polonia, 02-796
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Warszawa, Polonia, 03-335
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Wroclaw, Polonia, 50-088
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Bucharest, Romania, 7000
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Bucharesti, Romania, 7000
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Bucuresti, Romania, 050521
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Bucuresti, Romania, 70231
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Cluj-Napoca, Romania, 400349
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Iasi, Romania, 700111
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Napoca
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Cluj-, Napoca, Romania, 400000
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Bratislava, Slovacchia, 826 06
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Bratislava, Slovacchia, 83301
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Bratislava, Slovacchia, 851 07
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Bratislava, Slovacchia, 833 01
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Slovak Republic
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Piestany, Slovak Republic, Slovacchia
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Madrid, Spagna, 28006
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Madrid, Spagna, 28040
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Madrid, Spagna, 28046
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Madrid, Spagna, 28009
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Alabama
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Birmingham, Alabama, Stati Uniti, 35233
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Birmingham, Alabama, Stati Uniti, 35249-7201
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Birmingham, Alabama, Stati Uniti, 35294-3708
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Huntsville, Alabama, Stati Uniti, 35801
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Mobile, Alabama, Stati Uniti, 36608
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Arizona
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Glendale, Arizona, Stati Uniti, 85306
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Phoenix, Arizona, Stati Uniti, 85016
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Phoenix, Arizona, Stati Uniti, 85050
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Phoenix, Arizona, Stati Uniti, 85013
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Phoenix, Arizona, Stati Uniti, 85020
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Phoenix, Arizona, Stati Uniti, 85007
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Phoenix, Arizona, Stati Uniti, 85027
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Phoenix, Arizona, Stati Uniti, 85015
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Phoenix, Arizona, Stati Uniti, 85013-3903
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Scottsdale, Arizona, Stati Uniti, 85251
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Scottsdale, Arizona, Stati Uniti, 85254
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California
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Anaheim, California, Stati Uniti, 92801
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Berkeley, California, Stati Uniti, 94705
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Beverly Hills, California, Stati Uniti, 90211
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Fresno, California, Stati Uniti, 93720
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Fresno, California, Stati Uniti, 93710
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La Jolla, California, Stati Uniti, 92037
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Oakland, California, Stati Uniti, 94612
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Palm Desert, California, Stati Uniti, 92260
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Palm Springs, California, Stati Uniti, 92262
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Palm Springs, California, Stati Uniti, 92263
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Palm Springs, California, Stati Uniti, 92260
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Rancho Mirage, California, Stati Uniti, 92270
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Sacramento, California, Stati Uniti, 95817
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Sacramento, California, Stati Uniti, 95825
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Sacramento, California, Stati Uniti, 95816
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San Diego, California, Stati Uniti, 92108
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San Diego, California, Stati Uniti, 92120
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Upland, California, Stati Uniti, 91786
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Whittier, California, Stati Uniti, 90602
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Colorado
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Lakewood, Colorado, Stati Uniti, 80227
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Longmont, Colorado, Stati Uniti, 80501
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Wheat Ridge, Colorado, Stati Uniti, 80033
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Connecticut
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Bridgeport, Connecticut, Stati Uniti, 06606
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Hamden, Connecticut, Stati Uniti, 06518
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Madison, Connecticut, Stati Uniti, 06443
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Waterbury, Connecticut, Stati Uniti, 06708
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Delaware
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Newark, Delaware, Stati Uniti, 19713
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20037
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Washington, District of Columbia, Stati Uniti, 20007-2197
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Washington, District of Columbia, Stati Uniti, 20007
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Washington, District of Columbia, Stati Uniti, 20006
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Florida
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Aventura, Florida, Stati Uniti, 33180
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Boca Raton, Florida, Stati Uniti, 33432
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Clearwater, Florida, Stati Uniti, 33761
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Daytona Beach, Florida, Stati Uniti, 32114
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Daytona Beach, Florida, Stati Uniti, 32117
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Delray Beach, Florida, Stati Uniti, 33484
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Fort Myers, Florida, Stati Uniti, 33919
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Ft. Myers, Florida, Stati Uniti, 33916
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Gainesville, Florida, Stati Uniti, 32601
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Holiday, Florida, Stati Uniti, 34690
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Lake Worth, Florida, Stati Uniti, 33461
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Largo, Florida, Stati Uniti, 33773
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Ormond Beach, Florida, Stati Uniti, 32174
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Palm Beach Gardens, Florida, Stati Uniti, 33410
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Palm Harbor, Florida, Stati Uniti, 34684
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Pembroke Pines, Florida, Stati Uniti, 33027
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Pembroke Pines, Florida, Stati Uniti, 33029
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Plantation, Florida, Stati Uniti, 33324
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Port Orange, Florida, Stati Uniti, 32127
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Sarasota, Florida, Stati Uniti, 34239
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Sarasota, Florida, Stati Uniti, 34231
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St Petersburg, Florida, Stati Uniti, 33710
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West Palm Beach, Florida, Stati Uniti, 33401
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West Palm Beach, Florida, Stati Uniti, 33407
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West Palm Beach, Florida, Stati Uniti, 33409
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West Palm Beach, Florida, Stati Uniti, 33417
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Georgia
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Augusta, Georgia, Stati Uniti, 30909
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Decatur, Georgia, Stati Uniti, 30033
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Riverdale, Georgia, Stati Uniti, 30274
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Idaho
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Boise, Idaho, Stati Uniti, 83704
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Boise, Idaho, Stati Uniti, 83702
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Boise, Idaho, Stati Uniti, 83712
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Cadwell, Idaho, Stati Uniti, 83605
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Idaho Falls, Idaho, Stati Uniti, 83404
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Meridian, Idaho, Stati Uniti, 83642
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Illinois
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Champaign, Illinois, Stati Uniti, 61820
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Chicago, Illinois, Stati Uniti, 60612
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Libertyville, Illinois, Stati Uniti, 60048
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Peoria, Illinois, Stati Uniti, 61614
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Indiana
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Avon, Indiana, Stati Uniti, 46123
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Evansville, Indiana, Stati Uniti, 47714
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Evansville, Indiana, Stati Uniti, 47712
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Evansville, Indiana, Stati Uniti, 47750
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160-7136
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40207
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Louisville, Kentucky, Stati Uniti, 40291
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Lousiville, Kentucky, Stati Uniti, 40291
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Maine
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Bangor, Maine, Stati Uniti, 04401
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Bangor, Maine, Stati Uniti, 4401
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Maryland
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Bethesda, Maryland, Stati Uniti, 20817
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Silver Spring, Maryland, Stati Uniti, 20902
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Wheaton, Maryland, Stati Uniti, 20902
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
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Brookline, Massachusetts, Stati Uniti, 02445
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Fall River, Massachusetts, Stati Uniti, 02720
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Fall River, Massachusetts, Stati Uniti, 02721
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Michigan
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Grand Rapids, Michigan, Stati Uniti, 49546
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Grand Rapids, Michigan, Stati Uniti, 49503
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Kalamazaoo, Michigan, Stati Uniti, 49048
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Kalamazoo, Michigan, Stati Uniti, 49048
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Minnesota
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Brooklyn Center, Minnesota, Stati Uniti, 55430
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Robbinsdale, Minnesota, Stati Uniti, 55422
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Shoreview, Minnesota, Stati Uniti, 55126
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Mississippi
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Flowood, Mississippi, Stati Uniti, 39232
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Jackson, Mississippi, Stati Uniti, 39216
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Missouri
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Jefferson City, Missouri, Stati Uniti, 65109
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St Louis, Missouri, Stati Uniti, 63141
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St. Louis, Missouri, Stati Uniti, 63141
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Montana
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Billings, Montana, Stati Uniti, 59101
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Bozeman, Montana, Stati Uniti, 59715
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Missoula, Montana, Stati Uniti, 59801
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Missoula, Montana, Stati Uniti, 59804
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Missoula, Montana, Stati Uniti, 59802
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Nebraska
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Lincoln, Nebraska, Stati Uniti, 68510
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Nevada
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Henderson, Nevada, Stati Uniti, 89014
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North Las Vegas, Nevada, Stati Uniti, 89030
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Reno, Nevada, Stati Uniti, 89503
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Reno, Nevada, Stati Uniti, 89502-1196
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New Jersey
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Manchester Twp, New Jersey, Stati Uniti, 08759
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Ocean, New Jersey, Stati Uniti, 07712
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Princeton, New Jersey, Stati Uniti, 08542
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87102
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Albuquerque, New Mexico, Stati Uniti, 87109
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Albuquerque, New Mexico, Stati Uniti, 87106
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New York
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Bronx, New York, Stati Uniti, 10461
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New Hyde Park, New York, Stati Uniti, 11042
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New York, New York, Stati Uniti, 10029
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28277
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Charlotte, North Carolina, Stati Uniti, 28207
- Pfizer Investigational Site
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Charlotte, North Carolina, Stati Uniti, 28209
- Pfizer Investigational Site
-
Winston-Salem, North Carolina, Stati Uniti, 27103
- Pfizer Investigational Site
-
-
North Dakota
-
Bismarck, North Dakota, Stati Uniti, 58501
- Pfizer Investigational Site
-
Bismark, North Dakota, Stati Uniti, 58501
- Pfizer Investigational Site
-
Bismark, North Dakota, Stati Uniti, 58503
- Pfizer Investigational Site
-
Fargo, North Dakota, Stati Uniti, 58103
- Pfizer Investigational Site
-
Fargo, North Dakota, Stati Uniti, 58104
- Pfizer Investigational Site
-
Jamestown, North Dakota, Stati Uniti, 58401
- Pfizer Investigational Site
-
Minot, North Dakota, Stati Uniti, 58701
- Pfizer Investigational Site
-
Minot, North Dakota, Stati Uniti, 58702
- Pfizer Investigational Site
-
Oakes, North Dakota, Stati Uniti, 58574
- Pfizer Investigational Site
-
-
Ohio
-
Akron, Ohio, Stati Uniti, 44312-1647
- Pfizer Investigational Site
-
Akron, Ohio, Stati Uniti, 44313
- Pfizer Investigational Site
-
Centerville, Ohio, Stati Uniti, 45459
- Pfizer Investigational Site
-
Cincinnati, Ohio, Stati Uniti, 45249
- Pfizer Investigational Site
-
Cincinnati, Ohio, Stati Uniti, 45236
- Pfizer Investigational Site
-
Cleveland, Ohio, Stati Uniti, 44122
- Pfizer Investigational Site
-
Kettering, Ohio, Stati Uniti, 45459
- Pfizer Investigational Site
-
Lyndhurst, Ohio, Stati Uniti, 44124
- Pfizer Investigational Site
-
Mayfield Village, Ohio, Stati Uniti, 44143
- Pfizer Investigational Site
-
-
Oklahoma
-
Oklahoma, Oklahoma, Stati Uniti, 73102
- Pfizer Investigational Site
-
Oklahoma, Oklahoma, Stati Uniti, 73120
- Pfizer Investigational Site
-
Oklahoma City, Oklahoma, Stati Uniti, 73112-4481
- Pfizer Investigational Site
-
Oklahoma City, Oklahoma, Stati Uniti, 73142
- Pfizer Investigational Site
-
Tulsa, Oklahoma, Stati Uniti, 74135
- Pfizer Investigational Site
-
Yukon, Oklahoma, Stati Uniti, 73099
- Pfizer Investigational Site
-
-
Pennsylvania
-
Altoona, Pennsylvania, Stati Uniti, 16602
- Pfizer Investigational Site
-
Camp Hill, Pennsylvania, Stati Uniti, 17011
- Pfizer Investigational Site
-
Duncansville, Pennsylvania, Stati Uniti, 16635
- Pfizer Investigational Site
-
Johnstown, Pennsylvania, Stati Uniti, 15904
- Pfizer Investigational Site
-
Langhome, Pennsylvania, Stati Uniti, 19047
- Pfizer Investigational Site
-
Lemoyne, Pennsylvania, Stati Uniti, 17043
- Pfizer Investigational Site
-
Newtown, Pennsylvania, Stati Uniti, 18940
- Pfizer Investigational Site
-
Sellersville, Pennsylvania, Stati Uniti, 18960
- Pfizer Investigational Site
-
West Reading, Pennsylvania, Stati Uniti, 19611
- Pfizer Investigational Site
-
Wyomissing, Pennsylvania, Stati Uniti, 19610
- Pfizer Investigational Site
-
-
South Carolina
-
Anderson, South Carolina, Stati Uniti, 29621
- Pfizer Investigational Site
-
Belton, South Carolina, Stati Uniti, 29627
- Pfizer Investigational Site
-
Mt. Pleasant, South Carolina, Stati Uniti, 29464
- Pfizer Investigational Site
-
-
South Dakota
-
Aberdeen, South Dakota, Stati Uniti, 57401
- Pfizer Investigational Site
-
Sioux Falls, South Dakota, Stati Uniti, 57105
- Pfizer Investigational Site
-
Waterdown, South Dakota, Stati Uniti, 57201
- Pfizer Investigational Site
-
Watertown, South Dakota, Stati Uniti, 57201
- Pfizer Investigational Site
-
-
Tennessee
-
Memphis, Tennessee, Stati Uniti, 38119
- Pfizer Investigational Site
-
Memphis, Tennessee, Stati Uniti, 38104
- Pfizer Investigational Site
-
Memphis, Tennessee, Stati Uniti, 38120
- Pfizer Investigational Site
-
Memphis, Tennessee, Stati Uniti, 38138
- Pfizer Investigational Site
-
Nashville, Tennessee, Stati Uniti, 37203
- Pfizer Investigational Site
-
-
Texas
-
Bellaire, Texas, Stati Uniti, 77401
- Pfizer Investigational Site
-
Dallas, Texas, Stati Uniti, 75231
- Pfizer Investigational Site
-
Dallas, Texas, Stati Uniti, 75230
- Pfizer Investigational Site
-
Dallas, Texas, Stati Uniti, 75243
- Pfizer Investigational Site
-
Dallas, Texas, Stati Uniti, 75230-2513
- Pfizer Investigational Site
-
Houston, Texas, Stati Uniti, 77030
- Pfizer Investigational Site
-
San Antonio, Texas, Stati Uniti, 78229
- Pfizer Investigational Site
-
San Antonio, Texas, Stati Uniti, 78229-3894
- Pfizer Investigational Site
-
San Antonio, Texas, Stati Uniti, 78220
- Pfizer Investigational Site
-
Temple, Texas, Stati Uniti, 76504
- Pfizer Investigational Site
-
Waco, Texas, Stati Uniti, 76708
- Pfizer Investigational Site
-
-
Utah
-
Salt Lake City, Utah, Stati Uniti, 84102-3015
- Pfizer Investigational Site
-
-
Virginia
-
Norfolk, Virginia, Stati Uniti, 23502
- Pfizer Investigational Site
-
Virginia Beach, Virginia, Stati Uniti, 23454
- Pfizer Investigational Site
-
-
Washington
-
Seattle, Washington, Stati Uniti, 98195
- Pfizer Investigational Site
-
Seattle, Washington, Stati Uniti, 98133
- Pfizer Investigational Site
-
Seattle, Washington, Stati Uniti, 98105-4631
- Pfizer Investigational Site
-
Seattle, Washington, Stati Uniti, 98105
- Pfizer Investigational Site
-
Spokane, Washington, Stati Uniti, 99204
- Pfizer Investigational Site
-
-
Wisconsin
-
Milwaukee, Wisconsin, Stati Uniti, 53226
- Pfizer Investigational Site
-
Milwaukee, Wisconsin, Stati Uniti, 53209
- Pfizer Investigational Site
-
-
Wyoming
-
Cheyenne, Wyoming, Stati Uniti, 82001
- Pfizer Investigational Site
-
-
-
-
-
Bedford Gardens, Sud Africa
- Pfizer Investigational Site
-
Johannesburg, Sud Africa, 2193
- Pfizer Investigational Site
-
Johannesburg, Sud Africa, 2196
- Pfizer Investigational Site
-
Johannesburg 2193, Sud Africa
- Pfizer Investigational Site
-
Johannesburg, 2193, Sud Africa
- Pfizer Investigational Site
-
Parow, Sud Africa, 7500
- Pfizer Investigational Site
-
Parow 7500, Sud Africa
- Pfizer Investigational Site
-
Pretoria, Sud Africa, 0181
- Pfizer Investigational Site
-
Pretoria, Sud Africa, 0042
- Pfizer Investigational Site
-
Pretoria, 0042, Sud Africa
- Pfizer Investigational Site
-
Pretoria, 0181, Sud Africa
- Pfizer Investigational Site
-
Somerset West, Sud Africa
- Pfizer Investigational Site
-
Somerset West, 7129, Sud Africa
- Pfizer Investigational Site
-
Somerset West, 7130, Sud Africa
- Pfizer Investigational Site
-
Stellenbosch 7600, Sud Africa
- Pfizer Investigational Site
-
-
Pretoria
-
Groenkloof, 0181, Pretoria, Sud Africa
- Pfizer Investigational Site
-
-
-
-
-
Bekescsaba, Ungheria, 5600
- Pfizer Investigational Site
-
H-6720 Szeged, Ungheria
- Pfizer Investigational Site
-
Kecskemet, Ungheria, 6000
- Pfizer Investigational Site
-
Mako, Ungheria, 6900
- Pfizer Investigational Site
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 55 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
Inclusion Criteria:
- Must be at least 2 years postmenopausal
- Osteoporotic subjects without vertebral fracture who meet BMD criteria, or Osteoporotic subjects with vertebral fracture
Exclusion Criteria:
- Diseases that may affect bone metabolism
- Vasomotor symptoms requiring treatment
- Known history or suspected cancer of the breast
- Active or past history of venous thromboembolic events
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: UN
|
BZA 20mg, daily, oral
|
|
Comparatore placebo: B
|
Placebo, daily, oral
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants With New Vertebral Fractures Through Month 36
Lasso di tempo: Baseline through Month 36
|
New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base.
Participant was counted only once irrespective of how many new vt fractures were diagnosed.
Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.
|
Baseline through Month 36
|
|
Percentage of Participants With New Vertebral Fractures Through Month 60
Lasso di tempo: Baseline through Month 60
|
New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base.
Participant was counted only once irrespective of how many new vt fractures were diagnosed.
Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.
|
Baseline through Month 60
|
|
Percentage of Participants With New Vertebral Fractures Through Month 84
Lasso di tempo: Baseline through Month 84
|
New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base.
Participant was counted only once irrespective of how many new vt fractures were diagnosed.
Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.
|
Baseline through Month 84
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of Breast Cancer Through Month 36
Lasso di tempo: Baseline through Month 36
|
Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis.
The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).
|
Baseline through Month 36
|
|
Incidence of Breast Cancer Through Month 60
Lasso di tempo: Baseline through Month 60
|
Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis.
The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).
|
Baseline through Month 60
|
|
Incidence of Breast Cancer Through Month 84
Lasso di tempo: Baseline through Month 84
|
Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis.
The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).
|
Baseline through Month 84
|
|
Percentage of Participants With New Clinical Vertebral Fractures Through Month 36
Lasso di tempo: Baseline through Month 36
|
A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s).
New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.
|
Baseline through Month 36
|
|
Percentage of Participants With New Clinical Vertebral Fractures Through Month 60
Lasso di tempo: Baseline through Month 60
|
A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s).
New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.
|
Baseline through Month 60
|
|
Percentage of Participants With New Clinical Vertebral Fractures Through Month 84
Lasso di tempo: Baseline through Month 84
|
A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s).
New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.
|
Baseline through Month 84
|
|
Number of Participants With Worsening Vertebral Fractures Through Month 36
Lasso di tempo: Baseline through Month 36
|
A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale.
It can occur only in a vertebra that was fractured at baseline.
|
Baseline through Month 36
|
|
Number of Participants With Worsening Vertebral Fractures Through Month 60
Lasso di tempo: Baseline through Month 60
|
A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale.
It can occur only in a vertebra that was fractured at baseline.
|
Baseline through Month 60
|
|
Number of Participants With Worsening Vertebral Fractures Through Month 84
Lasso di tempo: Baseline through Month 84
|
A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale.
It can occur only in a vertebra that was fractured at baseline.
|
Baseline through Month 84
|
|
Percentage of Participants With Non-vertebral Fractures Through Month 36
Lasso di tempo: Baseline through Month 36
|
Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins.
Osteoporosis-related, hip and wrist fractures were summarized.
|
Baseline through Month 36
|
|
Percentage of Participants With Non-vertebral Fractures Through Month 60
Lasso di tempo: Baseline through Month 60
|
Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins.
Osteoporosis-related, hip and wrist fractures were summarized.
|
Baseline through Month 60
|
|
Percentage of Participants With Non-vertebral Fractures Through Month 84
Lasso di tempo: Baseline through Month 84
|
Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins.
Osteoporosis-related, hip and wrist fractures were summarized.
|
Baseline through Month 84
|
|
Change From Baseline in Height at Month 36
Lasso di tempo: Baseline, Month 36
|
Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).
|
Baseline, Month 36
|
|
Change From Baseline in Height at Month 60
Lasso di tempo: Baseline, Month 60
|
Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).
|
Baseline, Month 60
|
|
Change From Baseline in Height at Month 84
Lasso di tempo: Baseline, Month 84
|
Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).
|
Baseline, Month 84
|
|
Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36
Lasso di tempo: Baseline, Months 6, 12, 18, 24, 36
|
BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA).
The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study.
Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean.
Normal BMD is a T-score of -1.0 or higher.
|
Baseline, Months 6, 12, 18, 24, 36
|
|
Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60
Lasso di tempo: Baseline, Month 48, 60
|
BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA).
The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study.
Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean.
Normal BMD is a T-score of -1.0 or higher.
|
Baseline, Month 48, 60
|
|
Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84
Lasso di tempo: Baseline, Month 72, 84
|
BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA).
The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study.
Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean.
Normal BMD is a T-score of -1.0 or higher.
|
Baseline, Month 72, 84
|
|
Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12
Lasso di tempo: Baseline, Months 3, 6, 12
|
Osteocalcin is a biochemical marker of bone formation.
Blood samples were collected to evaluate osteocalcin levels.
|
Baseline, Months 3, 6, 12
|
|
Percent Change From Baseline in Osteocalcin at Months 36 and 60
Lasso di tempo: Baseline, Months 36, 60
|
Osteocalcin is a biochemical marker of bone formation.
Blood samples were collected to evaluate osteocalcin levels.
|
Baseline, Months 36, 60
|
|
Percent Change From Baseline in Osteocalcin at Months 72 and 84
Lasso di tempo: Baseline, Months 72, 84
|
Osteocalcin is a biochemical marker of bone formation.
Blood samples were collected to evaluate osteocalcin levels.
|
Baseline, Months 72, 84
|
|
Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12
Lasso di tempo: Baseline, Months 3, 6, 12
|
C-telopeptide is a biochemical marker of bone formation.
Blood samples were collected to evaluate C-telopeptide levels.
|
Baseline, Months 3, 6, 12
|
|
Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60
Lasso di tempo: Baseline, Months 36, 60
|
C-telopeptide is a biochemical marker of bone formation.
Blood samples were collected to evaluate C-telopeptide levels.
|
Baseline, Months 36, 60
|
|
Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84
Lasso di tempo: Baseline, Months 72, 84
|
C-telopeptide is a biochemical marker of bone formation.
Blood samples were collected to evaluate C-telopeptide levels.
|
Baseline, Months 72, 84
|
|
Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36
Lasso di tempo: Baseline, Months 6, 12, 24, 36
|
Lipid parameters evaluated included total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), triglyceride (TG), high-density lipoprotein fraction 2 (HDL2) and high-density lipoprotein fraction 3 (HDL3).
|
Baseline, Months 6, 12, 24, 36
|
|
Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP
Lasso di tempo: Month 36
|
Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD.
Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).
|
Month 36
|
|
Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP
Lasso di tempo: Month 60
|
Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD.
Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).
|
Month 60
|
|
Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh
Lasso di tempo: Month 36
|
Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD.
Calculated indices included: Wall Thickness (WTh), Osteoid Thickness (OTh), Trabecular Thickness (TbTh), Trabecular Separation (TbSp) and Cortical thickness (CTh).
Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.
|
Month 36
|
|
Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh
Lasso di tempo: Month 60
|
Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD.
Calculated indices included: WTh, OTh, TbTh, TbSp and CTh.
Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.
|
Month 60
|
|
Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG]
Lasso di tempo: Month 36
|
Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD.
Calculated indices included: Total Surface (Goldner Slide) [TSG].
All specimens were demineralized and subjected to staining procedures (Goldner's staining).
Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.
|
Month 36
|
|
Bone Histomorphometric Indices at Month 60: TSG
Lasso di tempo: Month 60
|
Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD.
Calculated indices included: Total Surface (Goldner Slide) [TSG].
All specimens were demineralized and subjected to staining procedures (Goldner's staining).
Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.
|
Month 60
|
|
Bone Histomorphometric Indices at Month 36: TtAr
Lasso di tempo: Month 36
|
Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD.
Calculated variable: Tissue Area (TtAr).
Tissue area comprised of the porous calcified substance from which bones were made.
|
Month 36
|
|
Bone Histomorphometric Indices at Month 60: TtAr
Lasso di tempo: Month 60
|
Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD.
Calculated variable: Tissue Area (TtAr).
Tissue area comprised of the porous calcified substance from which bones were made.
|
Month 60
|
|
Bone Histomorphometric Indices at Month 36: BFP, RP and RmP
Lasso di tempo: Month 36
|
Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD.
Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP).
|
Month 36
|
|
Bone Histomorphometric Indices at Month 60: BFP, RP and RmP
Lasso di tempo: Month 60
|
Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD.
Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP).
|
Month 60
|
|
Bone Histomorphometric Indices at Month 36: SuD
Lasso di tempo: Month 36
|
Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD).
|
Month 36
|
|
Bone Histomorphometric Indices at Month 60: SuD
Lasso di tempo: Month 60
|
Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD).
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Month 60
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Bone Histomorphometric Indices at Month 36: BFRTS
Lasso di tempo: Month 36
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Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS).
BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active.
BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).
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Month 36
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Bone Histomorphometric Indices at Month 60: BFRTS
Lasso di tempo: Month 60
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Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS).
BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active.
BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).
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Month 60
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Bone Histomorphometric Indices at Month 36: ACF
Lasso di tempo: Month 36
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Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF).
The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP.
The number of times per year that this spot begins the FP is the activation frequency (ACF).
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Month 36
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Bone Histomorphometric Indices at Month 60: ACF
Lasso di tempo: Month 60
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Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF).
The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP.
The number of times per year that this spot begins the FP is the activation frequency (ACF).
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Month 60
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Bone Histomorphometric Indices at Month 36: Mlt
Lasso di tempo: Month 36
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Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt).
Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.
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Month 36
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Bone Histomorphometric Indices at Month 60: Mlt
Lasso di tempo: Month 60
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Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt).
Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.
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Month 60
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Bone Histomorphometric Indices at Month 36: MAR
Lasso di tempo: Month 36
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Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR).
MAR is the area of new bone formed during the label interval.
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Month 36
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Bone Histomorphometric Indices at Month 60: MAR
Lasso di tempo: Month 60
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Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR).
MAR is the area of new bone formed during the label interval.
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Month 60
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Bone Histomorphometric Indices at Month 36: TbN
Lasso di tempo: Month 36
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Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN).
TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.
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Month 36
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Bone Histomorphometric Indices at Month 60: TbN
Lasso di tempo: Month 60
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Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN).
TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.
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Month 60
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Bone Histomorphometric Indices at Month 36: BFRBV
Lasso di tempo: Month 36
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Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV).
BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active.
BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).
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Month 36
|
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Bone Histomorphometric Indices at Month 60: BFRBV
Lasso di tempo: Month 60
|
Bone histomorphometry verified rate of bone remodeling.
Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone.
Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV).
BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active.
BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).
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Month 60
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Women's Health Questionnaire (WHQ)
Lasso di tempo: Baseline
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WHQ is a measure of mid-aged women's emotional and physical health.
Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness.
Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes).
Domain subscale score was calculated as sum of domain items score divided by number of domain items.
Total score was calculated as the sum of individual domain subscale score divided by number of domains.
Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction.
Baseline values at different time points were considered only for the participants who were evaluable at those time points.
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Baseline
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Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36
Lasso di tempo: Baseline, Months 12, 24, 36
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WHQ is a measure of mid-aged women's emotional and physical health.
Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness.
Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes).
Domain subscale score was calculated as sum of domain items score divided by number of domain items.
Total score was calculated as the sum of individual domain subscale score divided by number of domains.
Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction.Baseline values at different time points were considered only for the participants who were evaluable at those time points.
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Baseline, Months 12, 24, 36
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European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO)
Lasso di tempo: Baseline
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QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life.
The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function.
The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation.
Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Baseline values at different time points were considered only for the participants who were evaluable at those time points.
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Baseline
|
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Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36
Lasso di tempo: Baseline, Months 12, 24, 36
|
QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life.
The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function.
The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation.
Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Baseline values at different time points were considered only for the participants who were evaluable at those time points.
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Baseline, Months 12, 24, 36
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Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
Lasso di tempo: Baseline
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EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Baseline values at different time points were considered only for the participants who were evaluable at those time points.
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Baseline
|
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Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36
Lasso di tempo: Baseline, Months 12, 24, 36
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EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Baseline values at different time points were considered only for the participants who were evaluable at those time points.
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Baseline, Months 12, 24, 36
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Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score
Lasso di tempo: Baseline
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EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Baseline values at different time points were considered only for the participants who were evaluable at those time points.
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Baseline
|
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Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36
Lasso di tempo: Baseline, Months 12, 24, 36
|
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Baseline values at different time points were considered only for the participants who were evaluable at those time points.
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Baseline, Months 12, 24, 36
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 dicembre 2001
Completamento primario (Effettivo)
1 settembre 2010
Completamento dello studio (Effettivo)
1 settembre 2010
Date di iscrizione allo studio
Primo inviato
16 settembre 2005
Primo inviato che soddisfa i criteri di controllo qualità
16 settembre 2005
Primo Inserito (Stima)
20 settembre 2005
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
10 aprile 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 febbraio 2013
Ultimo verificato
1 febbraio 2013
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie metaboliche
- Malattie muscoloscheletriche
- Malattie ossee
- Malattie ossee, metaboliche
- Osteoporosi
- Effetti fisiologici delle droghe
- Ormoni, sostituti ormonali e antagonisti ormonali
- Antagonisti ormonali
- Agenti di conservazione della densità ossea
- Modulatori selettivi del recettore degli estrogeni
- Modulatori del recettore degli estrogeni
- Bazedoxifene
Altri numeri di identificazione dello studio
- 3068A1-301
- B1781001
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .