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Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

28. februar 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

7609

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

55 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: EN
Medicin: Bazedoxifene Acetate
BZA 20mg, daily, oral
Placebo komparator: B
Andet: Placebo
Placebo, daily, oral

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With New Vertebral Fractures Through Month 36
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Breast Cancer Through Month 36
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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]
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, Months 12, 24, 36
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Baseline, Months 12, 24, 36

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Publikationer og nyttige links

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Generelle publikationer

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2001

Primær færdiggørelse (Faktiske)

1. september 2010

Studieafslutning (Faktiske)

1. september 2010

Datoer for studieregistrering

Først indsendt

16. september 2005

Først indsendt, der opfyldte QC-kriterier

16. september 2005

Først opslået (Skøn)

20. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. februar 2013

Sidst verificeret

1. februar 2013

Mere information

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Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 3068A1-301
  • B1781001

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