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Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

28 февраля 2013 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

7609

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Австралия
      • Herston, Австралия, QLD 4029
        • Pfizer Investigational Site
      • Keswick, Австралия
        • Pfizer Investigational Site
    • New South Wales
      • Concord, New South Wales, Австралия, 2139
        • Pfizer Investigational Site
      • St Leonards, New South Wales, Австралия, 2065
        • Pfizer Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Австралия, 6009
        • Pfizer Investigational Site
  • Австрия
      • Graz, Австрия, 8036
        • Pfizer Investigational Site
  • Аргентина
      • Provincia de Buenos Aires, Аргентина
        • Pfizer Investigational Site
  • Бельгия
      • Diepenbeek, Бельгия, 3590
        • Pfizer Investigational Site
      • Genk, Бельгия, 3600
        • Pfizer Investigational Site
      • Gent, Бельгия, 9000
        • Pfizer Investigational Site
      • Leuven, Бельгия, 3000
        • Pfizer Investigational Site
      • Liege, Бельгия, 4000
        • Pfizer Investigational Site
      • Schiepsebos, Бельгия, 6
        • Pfizer Investigational Site
  • Болгария
      • Pleven, Болгария, 5800
        • Pfizer Investigational Site
      • Plovdiv, Болгария, 4002
        • Pfizer Investigational Site
      • Sofia, Болгария, 1504
        • Pfizer Investigational Site
      • Sofia, Болгария, 1431
        • Pfizer Investigational Site
      • Sofia, Болгария, 1407
        • Pfizer Investigational Site
      • Sofia, Болгария, 1301
        • Pfizer Investigational Site
      • Sofia, Болгария, 1303
        • Pfizer Investigational Site
  • Бразилия
    • GO
      • Goiania, GO, Бразилия, 74175-080
        • Pfizer Investigational Site
    • MT
      • Duque de Caxias - Cuiaba, MT, Бразилия, 78043-306
        • Pfizer Investigational Site
    • RJ
      • Rio de Janeiro, RJ, Бразилия, 22271-100
        • Pfizer Investigational Site
      • Rio de Janeiro, RJ, Бразилия, 20020-020
        • Pfizer Investigational Site
    • SP
      • São Paulo, SP, Бразилия, 04020-060
        • Pfizer Investigational Site
    • Sao Paulo
      • Sorocaba, Sao Paulo, Бразилия, 18095-450
        • Pfizer Investigational Site
  • Венгрия
      • Bekescsaba, Венгрия, 5600
        • Pfizer Investigational Site
      • H-6720 Szeged, Венгрия
        • Pfizer Investigational Site
      • Kecskemet, Венгрия, 6000
        • Pfizer Investigational Site
      • Mako, Венгрия, 6900
        • Pfizer Investigational Site
  • Германия
      • Berlin, Германия, 12200
        • Pfizer Investigational Site
      • Muenchen, Германия, 80809
        • Pfizer Investigational Site
      • Zerbst, Германия, 39261
        • Pfizer Investigational Site
  • Гонконг
      • Hong Kong, Гонконг
        • Pfizer Investigational Site
      • PRC, Гонконг
        • Pfizer Investigational Site
      • Sai Ying Pung, Гонконг
        • Pfizer Investigational Site
  • Греция
      • Athens, Греция, 11526
        • Pfizer Investigational Site
  • Дания
      • Aalborg, Дания, 9000
        • Pfizer Investigational Site
      • Ballerup, Дания, 2750
        • Pfizer Investigational Site
      • Vejle, Дания, 7100
        • Pfizer Investigational Site
  • Испания
      • Madrid, Испания, 28006
        • Pfizer Investigational Site
      • Madrid, Испания, 28040
        • Pfizer Investigational Site
      • Madrid, Испания, 28046
        • Pfizer Investigational Site
      • Madrid, Испания, 28009
        • Pfizer Investigational Site
  • Италия
      • Roma, Италия, 00168
        • Pfizer Investigational Site
      • Roma, Италия, 00189
        • Pfizer Investigational Site
      • Roma, Италия, 00136
        • Pfizer Investigational Site
      • Siena, Италия, 53100
        • Pfizer Investigational Site
  • Канада
      • Quebec, Канада, G1S 2L6
        • Pfizer Investigational Site
      • Quebec, Канада, G1V 3M7
        • Pfizer Investigational Site
    • Alberta
      • Calgary, Alberta, Канада, T2N 4Z6
        • Pfizer Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Канада, V6H 3X8
        • Pfizer Investigational Site
      • Vancouver, British Columbia, Канада, V5Z 2N6
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Канада, R3A 1M3
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Канада, L8N 1Y2
        • Pfizer Investigational Site
      • Hawkesbury, Ontario, Канада, K6A 1A1
        • Pfizer Investigational Site
      • Hawkesbury, Ontario, Канада, K6A 3B2
        • Pfizer Investigational Site
      • London, Ontario, Канада, N6A 4V2
        • Pfizer Investigational Site
      • Toronto, Ontario, Канада, M5C 2T2
        • Pfizer Investigational Site
      • Toronto, Ontario, Канада, M5C 1R6
        • Pfizer Investigational Site
      • Toronto, Ontario, Канада, M5G 1E2
        • Pfizer Investigational Site
      • Toronto, Ontario, Канада, MB5 1W8
        • Pfizer Investigational Site
    • Quebec
      • Gatineau, Quebec, Канада, J8Y 6S9
        • Pfizer Investigational Site
      • Montreal, Quebec, Канада, H2X 1N8
        • Pfizer Investigational Site
      • Montreal, Quebec, Канада, H2L 1S6
        • Pfizer Investigational Site
      • Pointe-Claire, Quebec, Канада, H9R 4S3
        • Pfizer Investigational Site
      • Sherbrooke, Quebec, Канада, J1H 4J6
        • Pfizer Investigational Site
      • Trois-Rivieres, Quebec, Канада, G8Z 1Y2
        • Pfizer Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Канада, S7K 0H6
        • Pfizer Investigational Site
      • Saskatoon, Saskatchewan, Канада, S7K 1N4
        • Pfizer Investigational Site
  • Литва
      • Kaunas, Литва, LT-50009
        • Pfizer Investigational Site
      • Vilnius, Литва, LT-10318
        • Pfizer Investigational Site
      • Vilnius, Литва, LT-04130
        • Pfizer Investigational Site
  • Мексика
      • Mexico City, Мексика, 03100
        • Pfizer Investigational Site
      • Mexico D.F., Мексика, 11800
        • Pfizer Investigational Site
    • Estado de Mexico
      • seccion de Lomas Verdes, Estado de Mexico, Мексика, CP 53120
        • Pfizer Investigational Site
  • Нидерланды
      • Eindhoven, Нидерланды, 5611 NJ
        • Pfizer Investigational Site
      • Rotterdam, Нидерланды, 3001 HG
        • Pfizer Investigational Site
    • Dr
      • Emmen, Dr, Нидерланды, 7824 AA
        • Pfizer Investigational Site
    • GA
      • Nijmegen, GA, Нидерланды, 6525
        • Pfizer Investigational Site
    • HV
      • Amsterdam, HV, Нидерланды, 1081
        • Pfizer Investigational Site
    • SZ
      • Nijmegen, SZ, Нидерланды, 6532
        • Pfizer Investigational Site
  • Новая Зеландия
      • Auckland, Новая Зеландия
        • Pfizer Investigational Site
      • Dunedin, Новая Зеландия
        • Pfizer Investigational Site
    • Auckland
      • Milford, Auckland, Новая Зеландия
        • Pfizer Investigational Site
    • NZ
      • Christchurch, NZ, Новая Зеландия, 8143
        • Pfizer Investigational Site
  • Норвегия
      • Bergen, Норвегия, NO-5094
        • Pfizer Investigational Site
      • Hamar, Норвегия, 2317
        • Pfizer Investigational Site
      • Oslo, Норвегия, NO-0164
        • Pfizer Investigational Site
      • Oslo, Норвегия, NO-0176
        • Pfizer Investigational Site
      • Trondheim, Норвегия, 7006
        • Pfizer Investigational Site
      • Trondheim, Норвегия, NO-7006
        • Pfizer Investigational Site
  • Польша
      • Katowice, Польша, 40-084
        • Pfizer Investigational Site
      • Krakow, Польша, 30-017
        • Pfizer Investigational Site
      • Krakow, Польша, 31-501
        • Pfizer Investigational Site
      • Krakow, Польша, 30-007
        • Pfizer Investigational Site
      • Krakow, Польша, 30-224
        • Pfizer Investigational Site
      • Krakow, Польша, 30-510
        • Pfizer Investigational Site
      • Lublin, Польша, 20-090
        • Pfizer Investigational Site
      • Warszawa, Польша, 00-909
        • Pfizer Investigational Site
      • Warszawa, Польша, 02-341
        • Pfizer Investigational Site
      • Warszawa, Польша, 04-730
        • Pfizer Investigational Site
      • Warszawa, Польша, 00-315
        • Pfizer Investigational Site
      • Warszawa, Польша, 00-418
        • Pfizer Investigational Site
      • Warszawa, Польша, 00-655
        • Pfizer Investigational Site
      • Warszawa, Польша, 00-699
        • Pfizer Investigational Site
      • Warszawa, Польша, 02-796
        • Pfizer Investigational Site
      • Warszawa, Польша, 03-335
        • Pfizer Investigational Site
      • Wroclaw, Польша, 50-088
        • Pfizer Investigational Site
  • Российская Федерация
      • Moscow, Российская Федерация, 115522
        • Pfizer Investigational Site
      • Moscow, Российская Федерация, 119002
        • Pfizer Investigational Site
      • Moscow, Российская Федерация, 117036
        • Pfizer Investigational Site
      • Moscow, Российская Федерация, 101990
        • Pfizer Investigational Site
      • Moscow, Российская Федерация, 107014
        • Pfizer Investigational Site
      • Moscow, Российская Федерация, 121356
        • Pfizer Investigational Site
      • Moscow, Российская Федерация, 127299
        • Pfizer Investigational Site
      • Moscow, Российская Федерация, 129010
        • Pfizer Investigational Site
      • Saint Petersburg, Российская Федерация, 190068
        • Pfizer Investigational Site
      • St Petersburg, Российская Федерация, 194291
        • Pfizer Investigational Site
      • St. Petersburg, Российская Федерация, 199034
        • Pfizer Investigational Site
      • St. Petersburg, Российская Федерация, 1190068
        • Pfizer Investigational Site
      • St. Petersburg, Российская Федерация, 190068
        • Pfizer Investigational Site
  • Румыния
      • Bucharest, Румыния, 7000
        • Pfizer Investigational Site
      • Bucharesti, Румыния, 7000
        • Pfizer Investigational Site
      • Bucuresti, Румыния, 050521
        • Pfizer Investigational Site
      • Bucuresti, Румыния, 70231
        • Pfizer Investigational Site
      • Cluj-Napoca, Румыния, 400349
        • Pfizer Investigational Site
      • Iasi, Румыния, 700111
        • Pfizer Investigational Site
    • Napoca
      • Cluj-, Napoca, Румыния, 400000
        • Pfizer Investigational Site
  • Словакия
      • Bratislava, Словакия, 826 06
        • Pfizer Investigational Site
      • Bratislava, Словакия, 83301
        • Pfizer Investigational Site
      • Bratislava, Словакия, 851 07
        • Pfizer Investigational Site
      • Bratislava, Словакия, 833 01
        • Pfizer Investigational Site
    • Slovak Republic
      • Piestany, Slovak Republic, Словакия
        • Pfizer Investigational Site
  • Соединенные Штаты
    • Alabama
      • Birmingham, Alabama, Соединенные Штаты, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, Соединенные Штаты, 35249-7201
        • Pfizer Investigational Site
      • Birmingham, Alabama, Соединенные Штаты, 35294-3708
        • Pfizer Investigational Site
      • Huntsville, Alabama, Соединенные Штаты, 35801
        • Pfizer Investigational Site
      • Mobile, Alabama, Соединенные Штаты, 36608
        • Pfizer Investigational Site
    • Arizona
      • Glendale, Arizona, Соединенные Штаты, 85306
        • Pfizer Investigational Site
      • Phoenix, Arizona, Соединенные Штаты, 85016
        • Pfizer Investigational Site
      • Phoenix, Arizona, Соединенные Штаты, 85050
        • Pfizer Investigational Site
      • Phoenix, Arizona, Соединенные Штаты, 85013
        • Pfizer Investigational Site
      • Phoenix, Arizona, Соединенные Штаты, 85020
        • Pfizer Investigational Site
      • Phoenix, Arizona, Соединенные Штаты, 85007
        • Pfizer Investigational Site
      • Phoenix, Arizona, Соединенные Штаты, 85027
        • Pfizer Investigational Site
      • Phoenix, Arizona, Соединенные Штаты, 85015
        • Pfizer Investigational Site
      • Phoenix, Arizona, Соединенные Штаты, 85013-3903
        • Pfizer Investigational Site
      • Scottsdale, Arizona, Соединенные Штаты, 85251
        • Pfizer Investigational Site
      • Scottsdale, Arizona, Соединенные Штаты, 85254
        • Pfizer Investigational Site
    • California
      • Anaheim, California, Соединенные Штаты, 92801
        • Pfizer Investigational Site
      • Berkeley, California, Соединенные Штаты, 94705
        • Pfizer Investigational Site
      • Beverly Hills, California, Соединенные Штаты, 90211
        • Pfizer Investigational Site
      • Fresno, California, Соединенные Штаты, 93720
        • Pfizer Investigational Site
      • Fresno, California, Соединенные Штаты, 93710
        • Pfizer Investigational Site
      • La Jolla, California, Соединенные Штаты, 92037
        • Pfizer Investigational Site
      • Oakland, California, Соединенные Штаты, 94612
        • Pfizer Investigational Site
      • Palm Desert, California, Соединенные Штаты, 92260
        • Pfizer Investigational Site
      • Palm Springs, California, Соединенные Штаты, 92262
        • Pfizer Investigational Site
      • Palm Springs, California, Соединенные Штаты, 92263
        • Pfizer Investigational Site
      • Palm Springs, California, Соединенные Штаты, 92260
        • Pfizer Investigational Site
      • Rancho Mirage, California, Соединенные Штаты, 92270
        • Pfizer Investigational Site
      • Sacramento, California, Соединенные Штаты, 95817
        • Pfizer Investigational Site
      • Sacramento, California, Соединенные Штаты, 95825
        • Pfizer Investigational Site
      • Sacramento, California, Соединенные Штаты, 95816
        • Pfizer Investigational Site
      • San Diego, California, Соединенные Штаты, 92108
        • Pfizer Investigational Site
      • San Diego, California, Соединенные Штаты, 92120
        • Pfizer Investigational Site
      • Upland, California, Соединенные Штаты, 91786
        • Pfizer Investigational Site
      • Whittier, California, Соединенные Штаты, 90602
        • Pfizer Investigational Site
    • Colorado
      • Lakewood, Colorado, Соединенные Штаты, 80227
        • Pfizer Investigational Site
      • Longmont, Colorado, Соединенные Штаты, 80501
        • Pfizer Investigational Site
      • Wheat Ridge, Colorado, Соединенные Штаты, 80033
        • Pfizer Investigational Site
    • Connecticut
      • Bridgeport, Connecticut, Соединенные Штаты, 06606
        • Pfizer Investigational Site
      • Hamden, Connecticut, Соединенные Штаты, 06518
        • Pfizer Investigational Site
      • Madison, Connecticut, Соединенные Штаты, 06443
        • Pfizer Investigational Site
      • Waterbury, Connecticut, Соединенные Штаты, 06708
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, Соединенные Штаты, 19713
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Соединенные Штаты, 20037
        • Pfizer Investigational Site
      • Washington, District of Columbia, Соединенные Штаты, 20007-2197
        • Pfizer Investigational Site
      • Washington, District of Columbia, Соединенные Штаты, 20007
        • Pfizer Investigational Site
      • Washington, District of Columbia, Соединенные Штаты, 20006
        • Pfizer Investigational Site
    • Florida
      • Aventura, Florida, Соединенные Штаты, 33180
        • Pfizer Investigational Site
      • Boca Raton, Florida, Соединенные Штаты, 33432
        • Pfizer Investigational Site
      • Cape Coral, Florida, Соединенные Штаты, 33990
        • Pfizer Investigational Site
      • Clearwater, Florida, Соединенные Штаты, 33761
        • Pfizer Investigational Site
      • Daytona Beach, Florida, Соединенные Штаты, 32114
        • Pfizer Investigational Site
      • Daytona Beach, Florida, Соединенные Штаты, 32117
        • Pfizer Investigational Site
      • Delray Beach, Florida, Соединенные Штаты, 33484
        • Pfizer Investigational Site
      • Fort Myers, Florida, Соединенные Штаты, 33919
        • Pfizer Investigational Site
      • Ft. Myers, Florida, Соединенные Штаты, 33916
        • Pfizer Investigational Site
      • Gainesville, Florida, Соединенные Штаты, 32601
        • Pfizer Investigational Site
      • Holiday, Florida, Соединенные Штаты, 34690
        • Pfizer Investigational Site
      • Lake Worth, Florida, Соединенные Штаты, 33461
        • Pfizer Investigational Site
      • Largo, Florida, Соединенные Штаты, 33773
        • Pfizer Investigational Site
      • Ormond Beach, Florida, Соединенные Штаты, 32174
        • Pfizer Investigational Site
      • Palm Beach Gardens, Florida, Соединенные Штаты, 33410
        • Pfizer Investigational Site
      • Palm Harbor, Florida, Соединенные Штаты, 34684
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, Соединенные Штаты, 33027
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, Соединенные Штаты, 33029
        • Pfizer Investigational Site
      • Plantation, Florida, Соединенные Штаты, 33324
        • Pfizer Investigational Site
      • Port Orange, Florida, Соединенные Штаты, 32127
        • Pfizer Investigational Site
      • Sarasota, Florida, Соединенные Штаты, 34239
        • Pfizer Investigational Site
      • Sarasota, Florida, Соединенные Штаты, 34231
        • Pfizer Investigational Site
      • St Petersburg, Florida, Соединенные Штаты, 33710
        • Pfizer Investigational Site
      • West Palm Beach, Florida, Соединенные Штаты, 33401
        • Pfizer Investigational Site
      • West Palm Beach, Florida, Соединенные Штаты, 33407
        • Pfizer Investigational Site
      • West Palm Beach, Florida, Соединенные Штаты, 33409
        • Pfizer Investigational Site
      • West Palm Beach, Florida, Соединенные Штаты, 33417
        • Pfizer Investigational Site
    • Georgia
      • Augusta, Georgia, Соединенные Штаты, 30909
        • Pfizer Investigational Site
      • Decatur, Georgia, Соединенные Штаты, 30033
        • Pfizer Investigational Site
      • Riverdale, Georgia, Соединенные Штаты, 30274
        • Pfizer Investigational Site
    • Idaho
      • Boise, Idaho, Соединенные Штаты, 83704
        • Pfizer Investigational Site
      • Boise, Idaho, Соединенные Штаты, 83702
        • Pfizer Investigational Site
      • Boise, Idaho, Соединенные Штаты, 83712
        • Pfizer Investigational Site
      • Cadwell, Idaho, Соединенные Штаты, 83605
        • Pfizer Investigational Site
      • Idaho Falls, Idaho, Соединенные Штаты, 83404
        • Pfizer Investigational Site
      • Meridian, Idaho, Соединенные Штаты, 83642
        • Pfizer Investigational Site
    • Illinois
      • Champaign, Illinois, Соединенные Штаты, 61820
        • Pfizer Investigational Site
      • Chicago, Illinois, Соединенные Штаты, 60612
        • Pfizer Investigational Site
      • Libertyville, Illinois, Соединенные Штаты, 60048
        • Pfizer Investigational Site
      • Peoria, Illinois, Соединенные Штаты, 61614
        • Pfizer Investigational Site
    • Indiana
      • Avon, Indiana, Соединенные Штаты, 46123
        • Pfizer Investigational Site
      • Evansville, Indiana, Соединенные Штаты, 47714
        • Pfizer Investigational Site
      • Evansville, Indiana, Соединенные Штаты, 47712
        • Pfizer Investigational Site
      • Evansville, Indiana, Соединенные Штаты, 47750
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, Соединенные Штаты, 66160-7136
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, Соединенные Штаты, 40207
        • Pfizer Investigational Site
      • Louisville, Kentucky, Соединенные Штаты, 40291
        • Pfizer Investigational Site
      • Lousiville, Kentucky, Соединенные Штаты, 40291
        • Pfizer Investigational Site
    • Maine
      • Bangor, Maine, Соединенные Штаты, 04401
        • Pfizer Investigational Site
      • Bangor, Maine, Соединенные Штаты, 4401
        • Pfizer Investigational Site
    • Maryland
      • Bethesda, Maryland, Соединенные Штаты, 20817
        • Pfizer Investigational Site
      • Silver Spring, Maryland, Соединенные Штаты, 20902
        • Pfizer Investigational Site
      • Wheaton, Maryland, Соединенные Штаты, 20902
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Соединенные Штаты, 02115
        • Pfizer Investigational Site
      • Brookline, Massachusetts, Соединенные Штаты, 02445
        • Pfizer Investigational Site
      • Fall River, Massachusetts, Соединенные Штаты, 02720
        • Pfizer Investigational Site
      • Fall River, Massachusetts, Соединенные Штаты, 02721
        • Pfizer Investigational Site
    • Michigan
      • Grand Rapids, Michigan, Соединенные Штаты, 49546
        • Pfizer Investigational Site
      • Grand Rapids, Michigan, Соединенные Штаты, 49503
        • Pfizer Investigational Site
      • Kalamazaoo, Michigan, Соединенные Штаты, 49048
        • Pfizer Investigational Site
      • Kalamazoo, Michigan, Соединенные Штаты, 49048
        • Pfizer Investigational Site
    • Minnesota
      • Brooklyn Center, Minnesota, Соединенные Штаты, 55430
        • Pfizer Investigational Site
      • Robbinsdale, Minnesota, Соединенные Штаты, 55422
        • Pfizer Investigational Site
      • Shoreview, Minnesota, Соединенные Штаты, 55126
        • Pfizer Investigational Site
    • Mississippi
      • Flowood, Mississippi, Соединенные Штаты, 39232
        • Pfizer Investigational Site
      • Jackson, Mississippi, Соединенные Штаты, 39216
        • Pfizer Investigational Site
    • Missouri
      • Jefferson City, Missouri, Соединенные Штаты, 65109
        • Pfizer Investigational Site
      • St Louis, Missouri, Соединенные Штаты, 63141
        • Pfizer Investigational Site
      • St. Louis, Missouri, Соединенные Штаты, 63141
        • Pfizer Investigational Site
    • Montana
      • Billings, Montana, Соединенные Штаты, 59101
        • Pfizer Investigational Site
      • Bozeman, Montana, Соединенные Штаты, 59715
        • Pfizer Investigational Site
      • Missoula, Montana, Соединенные Штаты, 59801
        • Pfizer Investigational Site
      • Missoula, Montana, Соединенные Штаты, 59804
        • Pfizer Investigational Site
      • Missoula, Montana, Соединенные Штаты, 59802
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, Соединенные Штаты, 68510
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, Соединенные Штаты, 89014
        • Pfizer Investigational Site
      • North Las Vegas, Nevada, Соединенные Штаты, 89030
        • Pfizer Investigational Site
      • Reno, Nevada, Соединенные Штаты, 89503
        • Pfizer Investigational Site
      • Reno, Nevada, Соединенные Штаты, 89502-1196
        • Pfizer Investigational Site
    • New Jersey
      • Manchester Twp, New Jersey, Соединенные Штаты, 08759
        • Pfizer Investigational Site
      • Ocean, New Jersey, Соединенные Штаты, 07712
        • Pfizer Investigational Site
      • Princeton, New Jersey, Соединенные Штаты, 08542
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Соединенные Штаты, 87102
        • Pfizer Investigational Site
      • Albuquerque, New Mexico, Соединенные Штаты, 87109
        • Pfizer Investigational Site
      • Albuquerque, New Mexico, Соединенные Штаты, 87106
        • Pfizer Investigational Site
    • New York
      • Bronx, New York, Соединенные Штаты, 10461
        • Pfizer Investigational Site
      • New Hyde Park, New York, Соединенные Штаты, 11042
        • Pfizer Investigational Site
      • New York, New York, Соединенные Штаты, 10029
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Соединенные Штаты, 28277
        • Pfizer Investigational Site
      • Charlotte, North Carolina, Соединенные Штаты, 28207
        • Pfizer Investigational Site
      • Charlotte, North Carolina, Соединенные Штаты, 28209
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, Соединенные Штаты, 27103
        • Pfizer Investigational Site
    • North Dakota
      • Bismarck, North Dakota, Соединенные Штаты, 58501
        • Pfizer Investigational Site
      • Bismark, North Dakota, Соединенные Штаты, 58501
        • Pfizer Investigational Site
      • Bismark, North Dakota, Соединенные Штаты, 58503
        • Pfizer Investigational Site
      • Fargo, North Dakota, Соединенные Штаты, 58103
        • Pfizer Investigational Site
      • Fargo, North Dakota, Соединенные Штаты, 58104
        • Pfizer Investigational Site
      • Jamestown, North Dakota, Соединенные Штаты, 58401
        • Pfizer Investigational Site
      • Minot, North Dakota, Соединенные Штаты, 58701
        • Pfizer Investigational Site
      • Minot, North Dakota, Соединенные Штаты, 58702
        • Pfizer Investigational Site
      • Oakes, North Dakota, Соединенные Штаты, 58574
        • Pfizer Investigational Site
    • Ohio
      • Akron, Ohio, Соединенные Штаты, 44312-1647
        • Pfizer Investigational Site
      • Akron, Ohio, Соединенные Штаты, 44313
        • Pfizer Investigational Site
      • Centerville, Ohio, Соединенные Штаты, 45459
        • Pfizer Investigational Site
      • Cincinnati, Ohio, Соединенные Штаты, 45249
        • Pfizer Investigational Site
      • Cincinnati, Ohio, Соединенные Штаты, 45236
        • Pfizer Investigational Site
      • Cleveland, Ohio, Соединенные Штаты, 44122
        • Pfizer Investigational Site
      • Kettering, Ohio, Соединенные Штаты, 45459
        • Pfizer Investigational Site
      • Lyndhurst, Ohio, Соединенные Штаты, 44124
        • Pfizer Investigational Site
      • Mayfield Village, Ohio, Соединенные Штаты, 44143
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma, Oklahoma, Соединенные Штаты, 73102
        • Pfizer Investigational Site
      • Oklahoma, Oklahoma, Соединенные Штаты, 73120
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, Соединенные Штаты, 73112-4481
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, Соединенные Штаты, 73142
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, Соединенные Штаты, 74135
        • Pfizer Investigational Site
      • Yukon, Oklahoma, Соединенные Штаты, 73099
        • Pfizer Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, Соединенные Штаты, 16602
        • Pfizer Investigational Site
      • Camp Hill, Pennsylvania, Соединенные Штаты, 17011
        • Pfizer Investigational Site
      • Duncansville, Pennsylvania, Соединенные Штаты, 16635
        • Pfizer Investigational Site
      • Johnstown, Pennsylvania, Соединенные Штаты, 15904
        • Pfizer Investigational Site
      • Langhome, Pennsylvania, Соединенные Штаты, 19047
        • Pfizer Investigational Site
      • Lemoyne, Pennsylvania, Соединенные Штаты, 17043
        • Pfizer Investigational Site
      • Newtown, Pennsylvania, Соединенные Штаты, 18940
        • Pfizer Investigational Site
      • Sellersville, Pennsylvania, Соединенные Штаты, 18960
        • Pfizer Investigational Site
      • West Reading, Pennsylvania, Соединенные Штаты, 19611
        • Pfizer Investigational Site
      • Wyomissing, Pennsylvania, Соединенные Штаты, 19610
        • Pfizer Investigational Site
    • South Carolina
      • Anderson, South Carolina, Соединенные Штаты, 29621
        • Pfizer Investigational Site
      • Belton, South Carolina, Соединенные Штаты, 29627
        • Pfizer Investigational Site
      • Mt. Pleasant, South Carolina, Соединенные Штаты, 29464
        • Pfizer Investigational Site
    • South Dakota
      • Aberdeen, South Dakota, Соединенные Штаты, 57401
        • Pfizer Investigational Site
      • Sioux Falls, South Dakota, Соединенные Штаты, 57105
        • Pfizer Investigational Site
      • Waterdown, South Dakota, Соединенные Штаты, 57201
        • Pfizer Investigational Site
      • Watertown, South Dakota, Соединенные Штаты, 57201
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, Соединенные Штаты, 38119
        • Pfizer Investigational Site
      • Memphis, Tennessee, Соединенные Штаты, 38104
        • Pfizer Investigational Site
      • Memphis, Tennessee, Соединенные Штаты, 38120
        • Pfizer Investigational Site
      • Memphis, Tennessee, Соединенные Штаты, 38138
        • Pfizer Investigational Site
      • Nashville, Tennessee, Соединенные Штаты, 37203
        • Pfizer Investigational Site
    • Texas
      • Bellaire, Texas, Соединенные Штаты, 77401
        • Pfizer Investigational Site
      • Dallas, Texas, Соединенные Штаты, 75231
        • Pfizer Investigational Site
      • Dallas, Texas, Соединенные Штаты, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, Соединенные Штаты, 75243
        • Pfizer Investigational Site
      • Dallas, Texas, Соединенные Штаты, 75230-2513
        • Pfizer Investigational Site
      • Houston, Texas, Соединенные Штаты, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, Соединенные Штаты, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, Соединенные Штаты, 78229-3894
        • Pfizer Investigational Site
      • San Antonio, Texas, Соединенные Штаты, 78220
        • Pfizer Investigational Site
      • Temple, Texas, Соединенные Штаты, 76504
        • Pfizer Investigational Site
      • Waco, Texas, Соединенные Штаты, 76708
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, Соединенные Штаты, 84102-3015
        • Pfizer Investigational Site
    • Virginia
      • Norfolk, Virginia, Соединенные Штаты, 23502
        • Pfizer Investigational Site
      • Virginia Beach, Virginia, Соединенные Штаты, 23454
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, Соединенные Штаты, 98195
        • Pfizer Investigational Site
      • Seattle, Washington, Соединенные Штаты, 98133
        • Pfizer Investigational Site
      • Seattle, Washington, Соединенные Штаты, 98105-4631
        • Pfizer Investigational Site
      • Seattle, Washington, Соединенные Штаты, 98105
        • Pfizer Investigational Site
      • Spokane, Washington, Соединенные Штаты, 99204
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Соединенные Штаты, 53226
        • Pfizer Investigational Site
      • Milwaukee, Wisconsin, Соединенные Штаты, 53209
        • Pfizer Investigational Site
    • Wyoming
      • Cheyenne, Wyoming, Соединенные Штаты, 82001
        • Pfizer Investigational Site
  • Финляндия
      • Jyvaskyla, Финляндия, FIN-40100
        • Pfizer Investigational Site
      • Jyväskylä, Финляндия, 40700
        • Pfizer Investigational Site
      • Kuopio, Финляндия, 70210
        • Pfizer Investigational Site
      • Kuopio, Финляндия, 70211
        • Pfizer Investigational Site
      • Kuopio, Финляндия, FIN-70211
        • Pfizer Investigational Site
      • Lahti, Финляндия
        • Pfizer Investigational Site
      • Oulu, Финляндия, 90 100
        • Pfizer Investigational Site
      • Turku, Финляндия, 20100
        • Pfizer Investigational Site
    • FIN
      • Jyvaskyla, FIN, Финляндия, 40100
        • Pfizer Investigational Site
  • Франция
      • Lyon Cedex 03, Франция, 69437
        • Pfizer Investigational Site
      • Orleans cedex 1, Франция, 45032
        • Pfizer Investigational Site
      • Paris, Франция, 75015
        • Pfizer Investigational Site
  • Хорватия
      • Zadar, Хорватия, 23000
        • Pfizer Investigational Site
      • Zagreb, Хорватия, 10000
        • Pfizer Investigational Site
  • Чили
      • Santiago, Чили
        • Pfizer Investigational Site
  • Эстония
      • Tallinn, Эстония, 10128
        • Pfizer Investigational Site
      • Tartu, Эстония, 50410
        • Pfizer Investigational Site
      • Tartu, Эстония
        • Pfizer Investigational Site
      • Tartu, Эстония, 51010
        • Pfizer Investigational Site
  • Южная Африка
      • Bedford Gardens, Южная Африка
        • Pfizer Investigational Site
      • Johannesburg, Южная Африка, 2193
        • Pfizer Investigational Site
      • Johannesburg, Южная Африка, 2196
        • Pfizer Investigational Site
      • Johannesburg 2193, Южная Африка
        • Pfizer Investigational Site
      • Johannesburg, 2193, Южная Африка
        • Pfizer Investigational Site
      • Parow, Южная Африка, 7500
        • Pfizer Investigational Site
      • Parow 7500, Южная Африка
        • Pfizer Investigational Site
      • Pretoria, Южная Африка, 0181
        • Pfizer Investigational Site
      • Pretoria, Южная Африка, 0042
        • Pfizer Investigational Site
      • Pretoria, 0042, Южная Африка
        • Pfizer Investigational Site
      • Pretoria, 0181, Южная Африка
        • Pfizer Investigational Site
      • Somerset West, Южная Африка
        • Pfizer Investigational Site
      • Somerset West, 7129, Южная Африка
        • Pfizer Investigational Site
      • Somerset West, 7130, Южная Африка
        • Pfizer Investigational Site
      • Stellenbosch 7600, Южная Африка
        • Pfizer Investigational Site
    • Pretoria
      • Groenkloof, 0181, Pretoria, Южная Африка
        • Pfizer Investigational Site

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 55 лет до 80 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Женский

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: А
Лекарство: Bazedoxifene Acetate
BZA 20mg, daily, oral
Плацебо Компаратор: Б
Другой: Placebo
Placebo, daily, oral

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants With New Vertebral Fractures Through Month 36
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Incidence of Breast Cancer Through Month 36
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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]
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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).
Month 60
Bone Histomorphometric Indices at Month 36: BFRTS
Временное ограничение: 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
Временное ограничение: 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).
Month 60
Bone Histomorphometric Indices at Month 36: ACF
Временное ограничение: 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).
Month 36
Bone Histomorphometric Indices at Month 60: ACF
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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).
Month 60
Women's Health Questionnaire (WHQ)
Временное ограничение: 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
Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

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Pfizer

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Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 декабря 2001 г.

Первичное завершение (Действительный)

1 сентября 2010 г.

Завершение исследования (Действительный)

1 сентября 2010 г.

Даты регистрации исследования

Первый отправленный

16 сентября 2005 г.

Впервые представлено, что соответствует критериям контроля качества

16 сентября 2005 г.

Первый опубликованный (Оценивать)

20 сентября 2005 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

10 апреля 2013 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

28 февраля 2013 г.

Последняя проверка

1 февраля 2013 г.

Дополнительная информация

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Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 3068A1-301
  • B1781001

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Клинические исследования Bazedoxifene Acetate

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