Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
28. února 2013 aktualizováno: 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.
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
7609
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Provincia de Buenos Aires, Argentina
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Herston, Austrálie, QLD 4029
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Keswick, Austrálie
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New South Wales
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Concord, New South Wales, Austrálie, 2139
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St Leonards, New South Wales, Austrálie, 2065
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Western Australia
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Nedlands, Western Australia, Austrálie, 6009
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Diepenbeek, Belgie, 3590
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Genk, Belgie, 3600
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Gent, Belgie, 9000
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Leuven, Belgie, 3000
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Liege, Belgie, 4000
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Schiepsebos, Belgie, 6
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GO
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Goiania, GO, Brazílie, 74175-080
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MT
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Duque de Caxias - Cuiaba, MT, Brazílie, 78043-306
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RJ
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Rio de Janeiro, RJ, Brazílie, 22271-100
- Pfizer Investigational Site
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Rio de Janeiro, RJ, Brazílie, 20020-020
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SP
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São Paulo, SP, Brazílie, 04020-060
- Pfizer Investigational Site
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Sao Paulo
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Sorocaba, Sao Paulo, Brazílie, 18095-450
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Pleven, Bulharsko, 5800
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Plovdiv, Bulharsko, 4002
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Sofia, Bulharsko, 1504
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Sofia, Bulharsko, 1431
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Sofia, Bulharsko, 1407
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Sofia, Bulharsko, 1301
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Sofia, Bulharsko, 1303
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Santiago, Chile
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Zadar, Chorvatsko, 23000
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Zagreb, Chorvatsko, 10000
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Aalborg, Dánsko, 9000
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Ballerup, Dánsko, 2750
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Vejle, Dánsko, 7100
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Tallinn, Estonsko, 10128
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Tartu, Estonsko, 50410
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Tartu, Estonsko
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Tartu, Estonsko, 51010
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Jyvaskyla, Finsko, FIN-40100
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Jyväskylä, Finsko, 40700
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Kuopio, Finsko, 70210
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Kuopio, Finsko, 70211
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Kuopio, Finsko, FIN-70211
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Lahti, Finsko
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Oulu, Finsko, 90 100
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Turku, Finsko, 20100
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FIN
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Jyvaskyla, FIN, Finsko, 40100
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Lyon Cedex 03, Francie, 69437
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Orleans cedex 1, Francie, 45032
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Paris, Francie, 75015
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Eindhoven, Holandsko, 5611 NJ
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Rotterdam, Holandsko, 3001 HG
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Dr
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Emmen, Dr, Holandsko, 7824 AA
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GA
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Nijmegen, GA, Holandsko, 6525
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HV
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Amsterdam, HV, Holandsko, 1081
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SZ
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Nijmegen, SZ, Holandsko, 6532
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Hong Kong, Hongkong
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PRC, Hongkong
- Pfizer Investigational Site
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Sai Ying Pung, Hongkong
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Roma, Itálie, 00168
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Roma, Itálie, 00189
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Roma, Itálie, 00136
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Siena, Itálie, 53100
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Bedford Gardens, Jižní Afrika
- Pfizer Investigational Site
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Johannesburg, Jižní Afrika, 2193
- Pfizer Investigational Site
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Johannesburg, Jižní Afrika, 2196
- Pfizer Investigational Site
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Johannesburg 2193, Jižní Afrika
- Pfizer Investigational Site
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Johannesburg, 2193, Jižní Afrika
- Pfizer Investigational Site
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Parow, Jižní Afrika, 7500
- Pfizer Investigational Site
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Parow 7500, Jižní Afrika
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Pretoria, Jižní Afrika, 0181
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Pretoria, Jižní Afrika, 0042
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Pretoria, 0042, Jižní Afrika
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Pretoria, 0181, Jižní Afrika
- Pfizer Investigational Site
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Somerset West, Jižní Afrika
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Somerset West, 7129, Jižní Afrika
- Pfizer Investigational Site
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Somerset West, 7130, Jižní Afrika
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Stellenbosch 7600, Jižní Afrika
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Pretoria
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Groenkloof, 0181, Pretoria, Jižní Afrika
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Quebec, Kanada, G1S 2L6
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Quebec, Kanada, G1V 3M7
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Alberta
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Calgary, Alberta, Kanada, T2N 4Z6
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British Columbia
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Vancouver, British Columbia, Kanada, V6H 3X8
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Vancouver, British Columbia, Kanada, V5Z 2N6
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Manitoba
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Winnipeg, Manitoba, Kanada, R3A 1M3
- Pfizer Investigational Site
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Ontario
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Hamilton, Ontario, Kanada, L8N 1Y2
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Hawkesbury, Ontario, Kanada, K6A 1A1
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Hawkesbury, Ontario, Kanada, K6A 3B2
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London, Ontario, Kanada, N6A 4V2
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Toronto, Ontario, Kanada, M5C 2T2
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Toronto, Ontario, Kanada, M5C 1R6
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Toronto, Ontario, Kanada, M5G 1E2
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Toronto, Ontario, Kanada, MB5 1W8
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Quebec
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Gatineau, Quebec, Kanada, J8Y 6S9
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Montreal, Quebec, Kanada, H2X 1N8
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Montreal, Quebec, Kanada, H2L 1S6
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Pointe-Claire, Quebec, Kanada, H9R 4S3
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Sherbrooke, Quebec, Kanada, J1H 4J6
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Trois-Rivieres, Quebec, Kanada, G8Z 1Y2
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7K 0H6
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Saskatoon, Saskatchewan, Kanada, S7K 1N4
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Kaunas, Litva, LT-50009
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Vilnius, Litva, LT-10318
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Vilnius, Litva, LT-04130
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Bekescsaba, Maďarsko, 5600
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H-6720 Szeged, Maďarsko
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Kecskemet, Maďarsko, 6000
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Mako, Maďarsko, 6900
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Mexico City, Mexiko, 03100
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Mexico D.F., Mexiko, 11800
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Estado de Mexico
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seccion de Lomas Verdes, Estado de Mexico, Mexiko, CP 53120
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Bergen, Norsko, NO-5094
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Hamar, Norsko, 2317
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Oslo, Norsko, NO-0164
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Oslo, Norsko, NO-0176
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Trondheim, Norsko, 7006
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Trondheim, Norsko, NO-7006
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Auckland, Nový Zéland
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Dunedin, Nový Zéland
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Auckland
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Milford, Auckland, Nový Zéland
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NZ
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Christchurch, NZ, Nový Zéland, 8143
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Berlin, Německo, 12200
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Muenchen, Německo, 80809
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Zerbst, Německo, 39261
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Katowice, Polsko, 40-084
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Krakow, Polsko, 30-017
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Krakow, Polsko, 31-501
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Krakow, Polsko, 30-007
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Krakow, Polsko, 30-224
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Krakow, Polsko, 30-510
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Lublin, Polsko, 20-090
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Warszawa, Polsko, 00-909
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Warszawa, Polsko, 02-341
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Warszawa, Polsko, 04-730
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Warszawa, Polsko, 00-315
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Warszawa, Polsko, 00-418
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Warszawa, Polsko, 00-655
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Warszawa, Polsko, 00-699
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Warszawa, Polsko, 02-796
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Warszawa, Polsko, 03-335
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Wroclaw, Polsko, 50-088
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Graz, Rakousko, 8036
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Bucharest, Rumunsko, 7000
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Bucharesti, Rumunsko, 7000
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Bucuresti, Rumunsko, 050521
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Bucuresti, Rumunsko, 70231
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Cluj-Napoca, Rumunsko, 400349
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Iasi, Rumunsko, 700111
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Napoca
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Cluj-, Napoca, Rumunsko, 400000
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Moscow, Ruská Federace, 115522
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Moscow, Ruská Federace, 119002
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Moscow, Ruská Federace, 117036
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Moscow, Ruská Federace, 101990
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Moscow, Ruská Federace, 107014
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Moscow, Ruská Federace, 121356
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Moscow, Ruská Federace, 127299
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Moscow, Ruská Federace, 129010
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Saint Petersburg, Ruská Federace, 190068
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St Petersburg, Ruská Federace, 194291
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St. Petersburg, Ruská Federace, 199034
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St. Petersburg, Ruská Federace, 1190068
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St. Petersburg, Ruská Federace, 190068
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Bratislava, Slovensko, 826 06
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Bratislava, Slovensko, 83301
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Bratislava, Slovensko, 851 07
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Bratislava, Slovensko, 833 01
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Slovak Republic
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Piestany, Slovak Republic, Slovensko
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Alabama
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Birmingham, Alabama, Spojené státy, 35233
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Birmingham, Alabama, Spojené státy, 35249-7201
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Birmingham, Alabama, Spojené státy, 35294-3708
- Pfizer Investigational Site
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Huntsville, Alabama, Spojené státy, 35801
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Mobile, Alabama, Spojené státy, 36608
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Arizona
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Glendale, Arizona, Spojené státy, 85306
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Phoenix, Arizona, Spojené státy, 85016
- Pfizer Investigational Site
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Phoenix, Arizona, Spojené státy, 85050
- Pfizer Investigational Site
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Phoenix, Arizona, Spojené státy, 85013
- Pfizer Investigational Site
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Phoenix, Arizona, Spojené státy, 85020
- Pfizer Investigational Site
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Phoenix, Arizona, Spojené státy, 85007
- Pfizer Investigational Site
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Phoenix, Arizona, Spojené státy, 85027
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Phoenix, Arizona, Spojené státy, 85015
- Pfizer Investigational Site
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Phoenix, Arizona, Spojené státy, 85013-3903
- Pfizer Investigational Site
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Scottsdale, Arizona, Spojené státy, 85251
- Pfizer Investigational Site
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Scottsdale, Arizona, Spojené státy, 85254
- Pfizer Investigational Site
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California
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Anaheim, California, Spojené státy, 92801
- Pfizer Investigational Site
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Berkeley, California, Spojené státy, 94705
- Pfizer Investigational Site
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Beverly Hills, California, Spojené státy, 90211
- Pfizer Investigational Site
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Fresno, California, Spojené státy, 93720
- Pfizer Investigational Site
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Fresno, California, Spojené státy, 93710
- Pfizer Investigational Site
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La Jolla, California, Spojené státy, 92037
- Pfizer Investigational Site
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Oakland, California, Spojené státy, 94612
- Pfizer Investigational Site
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Palm Desert, California, Spojené státy, 92260
- Pfizer Investigational Site
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Palm Springs, California, Spojené státy, 92262
- Pfizer Investigational Site
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Palm Springs, California, Spojené státy, 92263
- Pfizer Investigational Site
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Palm Springs, California, Spojené státy, 92260
- Pfizer Investigational Site
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Rancho Mirage, California, Spojené státy, 92270
- Pfizer Investigational Site
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Sacramento, California, Spojené státy, 95817
- Pfizer Investigational Site
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Sacramento, California, Spojené státy, 95825
- Pfizer Investigational Site
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Sacramento, California, Spojené státy, 95816
- Pfizer Investigational Site
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San Diego, California, Spojené státy, 92108
- Pfizer Investigational Site
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San Diego, California, Spojené státy, 92120
- Pfizer Investigational Site
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Upland, California, Spojené státy, 91786
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Whittier, California, Spojené státy, 90602
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Colorado
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Lakewood, Colorado, Spojené státy, 80227
- Pfizer Investigational Site
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Longmont, Colorado, Spojené státy, 80501
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Wheat Ridge, Colorado, Spojené státy, 80033
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Connecticut
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Bridgeport, Connecticut, Spojené státy, 06606
- Pfizer Investigational Site
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Hamden, Connecticut, Spojené státy, 06518
- Pfizer Investigational Site
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Madison, Connecticut, Spojené státy, 06443
- Pfizer Investigational Site
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Waterbury, Connecticut, Spojené státy, 06708
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Delaware
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Newark, Delaware, Spojené státy, 19713
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District of Columbia
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Washington, District of Columbia, Spojené státy, 20037
- Pfizer Investigational Site
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Washington, District of Columbia, Spojené státy, 20007-2197
- Pfizer Investigational Site
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Washington, District of Columbia, Spojené státy, 20007
- Pfizer Investigational Site
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Washington, District of Columbia, Spojené státy, 20006
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Florida
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Aventura, Florida, Spojené státy, 33180
- Pfizer Investigational Site
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Boca Raton, Florida, Spojené státy, 33432
- Pfizer Investigational Site
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Cape Coral, Florida, Spojené státy, 33990
- Pfizer Investigational Site
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Clearwater, Florida, Spojené státy, 33761
- Pfizer Investigational Site
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Daytona Beach, Florida, Spojené státy, 32114
- Pfizer Investigational Site
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Daytona Beach, Florida, Spojené státy, 32117
- Pfizer Investigational Site
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Delray Beach, Florida, Spojené státy, 33484
- Pfizer Investigational Site
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Fort Myers, Florida, Spojené státy, 33919
- Pfizer Investigational Site
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Ft. Myers, Florida, Spojené státy, 33916
- Pfizer Investigational Site
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Gainesville, Florida, Spojené státy, 32601
- Pfizer Investigational Site
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Holiday, Florida, Spojené státy, 34690
- Pfizer Investigational Site
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Lake Worth, Florida, Spojené státy, 33461
- Pfizer Investigational Site
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Largo, Florida, Spojené státy, 33773
- Pfizer Investigational Site
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Ormond Beach, Florida, Spojené státy, 32174
- Pfizer Investigational Site
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Palm Beach Gardens, Florida, Spojené státy, 33410
- Pfizer Investigational Site
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Palm Harbor, Florida, Spojené státy, 34684
- Pfizer Investigational Site
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Pembroke Pines, Florida, Spojené státy, 33027
- Pfizer Investigational Site
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Pembroke Pines, Florida, Spojené státy, 33029
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Plantation, Florida, Spojené státy, 33324
- Pfizer Investigational Site
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Port Orange, Florida, Spojené státy, 32127
- Pfizer Investigational Site
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Sarasota, Florida, Spojené státy, 34239
- Pfizer Investigational Site
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Sarasota, Florida, Spojené státy, 34231
- Pfizer Investigational Site
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St Petersburg, Florida, Spojené státy, 33710
- Pfizer Investigational Site
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West Palm Beach, Florida, Spojené státy, 33401
- Pfizer Investigational Site
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West Palm Beach, Florida, Spojené státy, 33407
- Pfizer Investigational Site
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West Palm Beach, Florida, Spojené státy, 33409
- Pfizer Investigational Site
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West Palm Beach, Florida, Spojené státy, 33417
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Georgia
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Augusta, Georgia, Spojené státy, 30909
- Pfizer Investigational Site
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Decatur, Georgia, Spojené státy, 30033
- Pfizer Investigational Site
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Riverdale, Georgia, Spojené státy, 30274
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Idaho
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Boise, Idaho, Spojené státy, 83704
- Pfizer Investigational Site
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Boise, Idaho, Spojené státy, 83702
- Pfizer Investigational Site
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Boise, Idaho, Spojené státy, 83712
- Pfizer Investigational Site
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Cadwell, Idaho, Spojené státy, 83605
- Pfizer Investigational Site
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Idaho Falls, Idaho, Spojené státy, 83404
- Pfizer Investigational Site
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Meridian, Idaho, Spojené státy, 83642
- Pfizer Investigational Site
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Illinois
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Champaign, Illinois, Spojené státy, 61820
- Pfizer Investigational Site
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Chicago, Illinois, Spojené státy, 60612
- Pfizer Investigational Site
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Libertyville, Illinois, Spojené státy, 60048
- Pfizer Investigational Site
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Peoria, Illinois, Spojené státy, 61614
- Pfizer Investigational Site
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Indiana
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Avon, Indiana, Spojené státy, 46123
- Pfizer Investigational Site
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Evansville, Indiana, Spojené státy, 47714
- Pfizer Investigational Site
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Evansville, Indiana, Spojené státy, 47712
- Pfizer Investigational Site
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Evansville, Indiana, Spojené státy, 47750
- Pfizer Investigational Site
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Kansas
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Kansas City, Kansas, Spojené státy, 66160-7136
- Pfizer Investigational Site
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Kentucky
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Louisville, Kentucky, Spojené státy, 40207
- Pfizer Investigational Site
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Louisville, Kentucky, Spojené státy, 40291
- Pfizer Investigational Site
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Lousiville, Kentucky, Spojené státy, 40291
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Maine
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Bangor, Maine, Spojené státy, 04401
- Pfizer Investigational Site
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Bangor, Maine, Spojené státy, 4401
- Pfizer Investigational Site
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Maryland
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Bethesda, Maryland, Spojené státy, 20817
- Pfizer Investigational Site
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Silver Spring, Maryland, Spojené státy, 20902
- Pfizer Investigational Site
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Wheaton, Maryland, Spojené státy, 20902
- Pfizer Investigational Site
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02115
- Pfizer Investigational Site
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Brookline, Massachusetts, Spojené státy, 02445
- Pfizer Investigational Site
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Fall River, Massachusetts, Spojené státy, 02720
- Pfizer Investigational Site
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Fall River, Massachusetts, Spojené státy, 02721
- Pfizer Investigational Site
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Michigan
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Grand Rapids, Michigan, Spojené státy, 49546
- Pfizer Investigational Site
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Grand Rapids, Michigan, Spojené státy, 49503
- Pfizer Investigational Site
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Kalamazaoo, Michigan, Spojené státy, 49048
- Pfizer Investigational Site
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Kalamazoo, Michigan, Spojené státy, 49048
- Pfizer Investigational Site
-
-
Minnesota
-
Brooklyn Center, Minnesota, Spojené státy, 55430
- Pfizer Investigational Site
-
Robbinsdale, Minnesota, Spojené státy, 55422
- Pfizer Investigational Site
-
Shoreview, Minnesota, Spojené státy, 55126
- Pfizer Investigational Site
-
-
Mississippi
-
Flowood, Mississippi, Spojené státy, 39232
- Pfizer Investigational Site
-
Jackson, Mississippi, Spojené státy, 39216
- Pfizer Investigational Site
-
-
Missouri
-
Jefferson City, Missouri, Spojené státy, 65109
- Pfizer Investigational Site
-
St Louis, Missouri, Spojené státy, 63141
- Pfizer Investigational Site
-
St. Louis, Missouri, Spojené státy, 63141
- Pfizer Investigational Site
-
-
Montana
-
Billings, Montana, Spojené státy, 59101
- Pfizer Investigational Site
-
Bozeman, Montana, Spojené státy, 59715
- Pfizer Investigational Site
-
Missoula, Montana, Spojené státy, 59801
- Pfizer Investigational Site
-
Missoula, Montana, Spojené státy, 59804
- Pfizer Investigational Site
-
Missoula, Montana, Spojené státy, 59802
- Pfizer Investigational Site
-
-
Nebraska
-
Lincoln, Nebraska, Spojené státy, 68510
- Pfizer Investigational Site
-
-
Nevada
-
Henderson, Nevada, Spojené státy, 89014
- Pfizer Investigational Site
-
North Las Vegas, Nevada, Spojené státy, 89030
- Pfizer Investigational Site
-
Reno, Nevada, Spojené státy, 89503
- Pfizer Investigational Site
-
Reno, Nevada, Spojené státy, 89502-1196
- Pfizer Investigational Site
-
-
New Jersey
-
Manchester Twp, New Jersey, Spojené státy, 08759
- Pfizer Investigational Site
-
Ocean, New Jersey, Spojené státy, 07712
- Pfizer Investigational Site
-
Princeton, New Jersey, Spojené státy, 08542
- Pfizer Investigational Site
-
-
New Mexico
-
Albuquerque, New Mexico, Spojené státy, 87102
- Pfizer Investigational Site
-
Albuquerque, New Mexico, Spojené státy, 87109
- Pfizer Investigational Site
-
Albuquerque, New Mexico, Spojené státy, 87106
- Pfizer Investigational Site
-
-
New York
-
Bronx, New York, Spojené státy, 10461
- Pfizer Investigational Site
-
New Hyde Park, New York, Spojené státy, 11042
- Pfizer Investigational Site
-
New York, New York, Spojené státy, 10029
- Pfizer Investigational Site
-
-
North Carolina
-
Charlotte, North Carolina, Spojené státy, 28277
- Pfizer Investigational Site
-
Charlotte, North Carolina, Spojené státy, 28207
- Pfizer Investigational Site
-
Charlotte, North Carolina, Spojené státy, 28209
- Pfizer Investigational Site
-
Winston-Salem, North Carolina, Spojené státy, 27103
- Pfizer Investigational Site
-
-
North Dakota
-
Bismarck, North Dakota, Spojené státy, 58501
- Pfizer Investigational Site
-
Bismark, North Dakota, Spojené státy, 58501
- Pfizer Investigational Site
-
Bismark, North Dakota, Spojené státy, 58503
- Pfizer Investigational Site
-
Fargo, North Dakota, Spojené státy, 58103
- Pfizer Investigational Site
-
Fargo, North Dakota, Spojené státy, 58104
- Pfizer Investigational Site
-
Jamestown, North Dakota, Spojené státy, 58401
- Pfizer Investigational Site
-
Minot, North Dakota, Spojené státy, 58701
- Pfizer Investigational Site
-
Minot, North Dakota, Spojené státy, 58702
- Pfizer Investigational Site
-
Oakes, North Dakota, Spojené státy, 58574
- Pfizer Investigational Site
-
-
Ohio
-
Akron, Ohio, Spojené státy, 44312-1647
- Pfizer Investigational Site
-
Akron, Ohio, Spojené státy, 44313
- Pfizer Investigational Site
-
Centerville, Ohio, Spojené státy, 45459
- Pfizer Investigational Site
-
Cincinnati, Ohio, Spojené státy, 45249
- Pfizer Investigational Site
-
Cincinnati, Ohio, Spojené státy, 45236
- Pfizer Investigational Site
-
Cleveland, Ohio, Spojené státy, 44122
- Pfizer Investigational Site
-
Kettering, Ohio, Spojené státy, 45459
- Pfizer Investigational Site
-
Lyndhurst, Ohio, Spojené státy, 44124
- Pfizer Investigational Site
-
Mayfield Village, Ohio, Spojené státy, 44143
- Pfizer Investigational Site
-
-
Oklahoma
-
Oklahoma, Oklahoma, Spojené státy, 73102
- Pfizer Investigational Site
-
Oklahoma, Oklahoma, Spojené státy, 73120
- Pfizer Investigational Site
-
Oklahoma City, Oklahoma, Spojené státy, 73112-4481
- Pfizer Investigational Site
-
Oklahoma City, Oklahoma, Spojené státy, 73142
- Pfizer Investigational Site
-
Tulsa, Oklahoma, Spojené státy, 74135
- Pfizer Investigational Site
-
Yukon, Oklahoma, Spojené státy, 73099
- Pfizer Investigational Site
-
-
Pennsylvania
-
Altoona, Pennsylvania, Spojené státy, 16602
- Pfizer Investigational Site
-
Camp Hill, Pennsylvania, Spojené státy, 17011
- Pfizer Investigational Site
-
Duncansville, Pennsylvania, Spojené státy, 16635
- Pfizer Investigational Site
-
Johnstown, Pennsylvania, Spojené státy, 15904
- Pfizer Investigational Site
-
Langhome, Pennsylvania, Spojené státy, 19047
- Pfizer Investigational Site
-
Lemoyne, Pennsylvania, Spojené státy, 17043
- Pfizer Investigational Site
-
Newtown, Pennsylvania, Spojené státy, 18940
- Pfizer Investigational Site
-
Sellersville, Pennsylvania, Spojené státy, 18960
- Pfizer Investigational Site
-
West Reading, Pennsylvania, Spojené státy, 19611
- Pfizer Investigational Site
-
Wyomissing, Pennsylvania, Spojené státy, 19610
- Pfizer Investigational Site
-
-
South Carolina
-
Anderson, South Carolina, Spojené státy, 29621
- Pfizer Investigational Site
-
Belton, South Carolina, Spojené státy, 29627
- Pfizer Investigational Site
-
Mt. Pleasant, South Carolina, Spojené státy, 29464
- Pfizer Investigational Site
-
-
South Dakota
-
Aberdeen, South Dakota, Spojené státy, 57401
- Pfizer Investigational Site
-
Sioux Falls, South Dakota, Spojené státy, 57105
- Pfizer Investigational Site
-
Waterdown, South Dakota, Spojené státy, 57201
- Pfizer Investigational Site
-
Watertown, South Dakota, Spojené státy, 57201
- Pfizer Investigational Site
-
-
Tennessee
-
Memphis, Tennessee, Spojené státy, 38119
- Pfizer Investigational Site
-
Memphis, Tennessee, Spojené státy, 38104
- Pfizer Investigational Site
-
Memphis, Tennessee, Spojené státy, 38120
- Pfizer Investigational Site
-
Memphis, Tennessee, Spojené státy, 38138
- Pfizer Investigational Site
-
Nashville, Tennessee, Spojené státy, 37203
- Pfizer Investigational Site
-
-
Texas
-
Bellaire, Texas, Spojené státy, 77401
- Pfizer Investigational Site
-
Dallas, Texas, Spojené státy, 75231
- Pfizer Investigational Site
-
Dallas, Texas, Spojené státy, 75230
- Pfizer Investigational Site
-
Dallas, Texas, Spojené státy, 75243
- Pfizer Investigational Site
-
Dallas, Texas, Spojené státy, 75230-2513
- Pfizer Investigational Site
-
Houston, Texas, Spojené státy, 77030
- Pfizer Investigational Site
-
San Antonio, Texas, Spojené státy, 78229
- Pfizer Investigational Site
-
San Antonio, Texas, Spojené státy, 78229-3894
- Pfizer Investigational Site
-
San Antonio, Texas, Spojené státy, 78220
- Pfizer Investigational Site
-
Temple, Texas, Spojené státy, 76504
- Pfizer Investigational Site
-
Waco, Texas, Spojené státy, 76708
- Pfizer Investigational Site
-
-
Utah
-
Salt Lake City, Utah, Spojené státy, 84102-3015
- Pfizer Investigational Site
-
-
Virginia
-
Norfolk, Virginia, Spojené státy, 23502
- Pfizer Investigational Site
-
Virginia Beach, Virginia, Spojené státy, 23454
- Pfizer Investigational Site
-
-
Washington
-
Seattle, Washington, Spojené státy, 98195
- Pfizer Investigational Site
-
Seattle, Washington, Spojené státy, 98133
- Pfizer Investigational Site
-
Seattle, Washington, Spojené státy, 98105-4631
- Pfizer Investigational Site
-
Seattle, Washington, Spojené státy, 98105
- Pfizer Investigational Site
-
Spokane, Washington, Spojené státy, 99204
- Pfizer Investigational Site
-
-
Wisconsin
-
Milwaukee, Wisconsin, Spojené státy, 53226
- Pfizer Investigational Site
-
Milwaukee, Wisconsin, Spojené státy, 53209
- Pfizer Investigational Site
-
-
Wyoming
-
Cheyenne, Wyoming, Spojené státy, 82001
- Pfizer Investigational Site
-
-
-
-
-
Athens, Řecko, 11526
- Pfizer Investigational Site
-
-
-
-
-
Madrid, Španělsko, 28006
- Pfizer Investigational Site
-
Madrid, Španělsko, 28040
- Pfizer Investigational Site
-
Madrid, Španělsko, 28046
- Pfizer Investigational Site
-
Madrid, Španělsko, 28009
- Pfizer Investigational Site
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
55 let až 80 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: A
|
BZA 20mg, daily, oral
|
|
Komparátor placeba: B
|
Placebo, daily, oral
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Participants With New Vertebral Fractures Through Month 36
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of Breast Cancer Through Month 36
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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]
Časové okno: 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.
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Month 36
|
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Bone Histomorphometric Indices at Month 60: TSG
Časové okno: 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.
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Month 60
|
|
Bone Histomorphometric Indices at Month 36: TtAr
Časové okno: 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.
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Month 36
|
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Bone Histomorphometric Indices at Month 60: TtAr
Časové okno: 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.
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Month 60
|
|
Bone Histomorphometric Indices at Month 36: BFP, RP and RmP
Časové okno: 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).
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Month 36
|
|
Bone Histomorphometric Indices at Month 60: BFP, RP and RmP
Časové okno: 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).
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Month 60
|
|
Bone Histomorphometric Indices at Month 36: SuD
Časové okno: 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
Časové okno: 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
|
|
Bone Histomorphometric Indices at Month 36: BFRTS
Časové okno: 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 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).
|
Month 36
|
|
Bone Histomorphometric Indices at Month 60: BFRTS
Časové okno: 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 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
Časové okno: 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: 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
|
|
Bone Histomorphometric Indices at Month 60: ACF
Časové okno: 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: 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).
|
Month 60
|
|
Bone Histomorphometric Indices at Month 36: Mlt
Časové okno: 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: Mineralization Lag Time (Mlt).
Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.
|
Month 36
|
|
Bone Histomorphometric Indices at Month 60: Mlt
Časové okno: 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: Mineralization Lag Time (Mlt).
Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.
|
Month 60
|
|
Bone Histomorphometric Indices at Month 36: MAR
Časové okno: 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: Mineral Apposition Rate (MAR).
MAR is the area of new bone formed during the label interval.
|
Month 36
|
|
Bone Histomorphometric Indices at Month 60: MAR
Časové okno: 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: Mineral Apposition Rate (MAR).
MAR is the area of new bone formed during the label interval.
|
Month 60
|
|
Bone Histomorphometric Indices at Month 36: TbN
Časové okno: 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: Trabecular Number (TbN).
TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.
|
Month 36
|
|
Bone Histomorphometric Indices at Month 60: TbN
Časové okno: 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: Trabecular Number (TbN).
TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.
|
Month 60
|
|
Bone Histomorphometric Indices at Month 36: BFRBV
Časové okno: 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 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).
|
Month 36
|
|
Bone Histomorphometric Indices at Month 60: BFRBV
Časové okno: 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
|
|
Women's Health Questionnaire (WHQ)
Časové okno: Baseline
|
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.
|
Baseline
|
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Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36
Časové okno: Baseline, Months 12, 24, 36
|
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.
|
Baseline, Months 12, 24, 36
|
|
European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO)
Časové okno: Baseline
|
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.
|
Baseline
|
|
Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36
Časové okno: 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.
|
Baseline, Months 12, 24, 36
|
|
Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
Časové okno: Baseline
|
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.
|
Baseline
|
|
Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36
Časové okno: Baseline, Months 12, 24, 36
|
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.
|
Baseline, Months 12, 24, 36
|
|
Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score
Časové okno: Baseline
|
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.
|
Baseline
|
|
Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36
Časové okno: 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.
|
Baseline, Months 12, 24, 36
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. prosince 2001
Primární dokončení (Aktuální)
1. září 2010
Dokončení studie (Aktuální)
1. září 2010
Termíny zápisu do studia
První předloženo
16. září 2005
První předloženo, které splnilo kritéria kontroly kvality
16. září 2005
První zveřejněno (Odhad)
20. září 2005
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
10. dubna 2013
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
28. února 2013
Naposledy ověřeno
1. února 2013
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Metabolické choroby
- Nemoci pohybového aparátu
- Nemoci kostí
- Nemoci kostí, Metabolické
- Osteoporóza
- Fyziologické účinky léků
- Hormony, hormonální náhražky a antagonisté hormonů
- Antagonisté hormonů
- Činidla pro zachování hustoty kostí
- Selektivní modulátory estrogenových receptorů
- Modulátory estrogenových receptorů
- Bazedoxifen
Další identifikační čísla studie
- 3068A1-301
- B1781001
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .