此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

2013年2月28日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

7609

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

55年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：单组作业
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器：一个
药品：Bazedoxifene Acetate
BZA 20mg, daily, oral
安慰剂比较：乙
其他：Placebo
Placebo, daily, oral

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants With New Vertebral Fractures Through Month 36
大体时间：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
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Incidence of Breast Cancer Through Month 36
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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]
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2001年12月1日

初级完成 (实际的)

2010年9月1日

研究完成 (实际的)

2010年9月1日

研究注册日期

首次提交

2005年9月16日

首先提交符合 QC 标准的

2005年9月16日

首次发布 (估计)

2005年9月20日

研究记录更新

最后更新发布 (估计)

2013年4月10日

上次提交的符合 QC 标准的更新

2013年2月28日

最后验证

2013年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 3068A1-301
  • B1781001

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

Bazedoxifene Acetate的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Papua New Guinea

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅