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Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

28 de febrero de 2013 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Osteoporosis

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

7609

Fase

Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

55 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Tratamiento
Asignación: Aleatorizado
Modelo Intervencionista: Asignación de un solo grupo
Enmascaramiento: Doble

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo	Intervención / Tratamiento
Comparador activo: A	Droga: Bazedoxifene Acetate BZA 20mg, daily, oral
Comparador de placebos: B	Otro: Placebo Placebo, daily, oral

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Percentage of Participants With New Vertebral Fractures Through Month 36 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Incidence of Breast Cancer Through Month 36 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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] Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Pfizer

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Christiansen C, Chesnut CH 3rd, Adachi JD, Brown JP, Fernandes CE, Kung AW, Palacios S, Levine AB, Chines AA, Constantine GD. Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled Phase 3 study of postmenopausal women with osteoporosis. BMC Musculoskelet Disord. 2010 Jun 22;11:130. doi: 10.1186/1471-2474-11-130.

Enlaces Útiles

To obtain contact information for a study center near you, click here.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de diciembre de 2001

Finalización primaria (Actual)

1 de septiembre de 2010

Finalización del estudio (Actual)

1 de septiembre de 2010

Fechas de registro del estudio

Enviado por primera vez

16 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

16 de septiembre de 2005

Publicado por primera vez (Estimar)

20 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

10 de abril de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

28 de febrero de 2013

Última verificación

1 de febrero de 2013

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

3068A1-301
B1781001

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Osteoporosis

Radius Health, Inc.

Terminado

Efectos iniciales de la abaloparatida en los índices de formación y reabsorción ósea basados en tejidos

Osteoporosis | Riesgo de osteoporosis | Osteoporosis Posmenopáusica | Fractura de osteoporosis | Osteoporosis relacionada con la edad | Osteoporosis localizada en la columna vertebral | Osteoporosis senil | Osteoporosis de vértebras | Osteoporosis Vertebral

Estados Unidos
Appalachian State University
North Carolina Agriculture & Technical State University

Terminado

Moringa Oleifera sobre la densidad ósea

Osteoporosis posmenopáusica | Osteoporosis, Osteopenia

Estados Unidos
Amgen

Terminado

Eficacia, seguridad y tolerabilidad de romosozumab en el tratamiento de mujeres japonesas con osteoporosis posmenopáusica

Osteoporosis posmenopáusica (OPM)

Japón
Deltanoid Pharmaceuticals

Terminado

Estudio de seguridad de un análogo de vitamina D oral en mujeres posmenopáusicas

Osteoporosis posmenopáusica, sitios múltiples
Radius Health, Inc.

Terminado

Seguridad y eficacia de abaloparatida-SC en hombres con osteoporosis (ATOM)

Osteoporosis | Osteoporosis relacionada con la edad | Osteoporosis relacionada con la edad | Osteoporosis localizada en la columna vertebral | Osteoporosis senil | Osteoporosis de vértebras

Estados Unidos, Polonia, Italia
Amgen

Terminado

Eficacia y seguridad del tratamiento con romosozumab en mujeres posmenopáusicas con osteoporosis (FRAME)

Osteoporosis posmenopáusica

Estados Unidos, Canadá, Dinamarca, Alemania, Bélgica, Colombia, Chequia, Japón, México, Polonia, Suiza, Hungría, España, Australia, Rumania, Reino Unido, India, Argentina, Brasil, República Dominicana, Estonia, Letonia, Lituania, Nueva Zelanda
Penn State University
California Dried Plum Board

Activo, no reclutando

Ciruelas secas y salud ósea en mujeres posmenopáusicas

Osteoporosis posmenopáusica

Estados Unidos
Massachusetts General Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Terminado

Efectos de modelado óseo de la administración combinada de anabólicos/antiabsortivos

Osteoporosis posmenopáusica

Estados Unidos
Sahlgrenska University Hospital, Sweden
BioGaia AB

Terminado

Prevención de la pérdida ósea posmenopáusica temprana con Lactobacillus Reuteri (ELBOWII)

Osteoporosis posmenopáusica

Suecia
Samsung Bioepis Co., Ltd.

Terminado

Un estudio para comparar SB16 (biosimilar propuesto de denosumab) con Prolia® en mujeres posmenopáusicas con osteoporosis

Osteoporosis posmenopáusica

Polonia

Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women

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Más información

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Ensayos clínicos sobre Osteoporosis

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