Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

February 28, 2013 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7609

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • Belgium
      • Diepenbeek, Belgium, 3590
        • Pfizer Investigational Site
      • Genk, Belgium, 3600
        • Pfizer Investigational Site
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
      • Liege, Belgium, 4000
        • Pfizer Investigational Site
      • Schiepsebos, Belgium, 6
        • Pfizer Investigational Site
  • Brazil
    • GO
      • Goiania, GO, Brazil, 74175-080
        • Pfizer Investigational Site
    • MT
      • Duque de Caxias - Cuiaba, MT, Brazil, 78043-306
        • Pfizer Investigational Site
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22271-100
        • Pfizer Investigational Site
      • Rio de Janeiro, RJ, Brazil, 20020-020
        • Pfizer Investigational Site
    • SP
      • São Paulo, SP, Brazil, 04020-060
        • Pfizer Investigational Site
    • Sao Paulo
      • Sorocaba, Sao Paulo, Brazil, 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
  • 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
  • Croatia
      • Zadar, Croatia, 23000
        • Pfizer Investigational Site
      • Zagreb, Croatia, 10000
        • Pfizer Investigational Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Pfizer Investigational Site
      • Ballerup, Denmark, 2750
        • Pfizer Investigational Site
      • Vejle, Denmark, 7100
        • 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
  • 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
  • France
      • Lyon Cedex 03, France, 69437
        • Pfizer Investigational Site
      • Orleans cedex 1, France, 45032
        • Pfizer Investigational Site
      • Paris, France, 75015
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 12200
        • Pfizer Investigational Site
      • Muenchen, Germany, 80809
        • Pfizer Investigational Site
      • Zerbst, Germany, 39261
        • Pfizer Investigational Site
  • Greece
      • Athens, Greece, 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
  • Hungary
      • Bekescsaba, Hungary, 5600
        • Pfizer Investigational Site
      • H-6720 Szeged, Hungary
        • Pfizer Investigational Site
      • Kecskemet, Hungary, 6000
        • Pfizer Investigational Site
      • Mako, Hungary, 6900
        • Pfizer Investigational Site
  • Italy
      • Roma, Italy, 00168
        • Pfizer Investigational Site
      • Roma, Italy, 00189
        • Pfizer Investigational Site
      • Roma, Italy, 00136
        • Pfizer Investigational Site
      • Siena, Italy, 53100
        • Pfizer Investigational Site
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • Pfizer Investigational Site
      • Vilnius, Lithuania, LT-10318
        • Pfizer Investigational Site
      • Vilnius, Lithuania, 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
  • Netherlands
      • Eindhoven, Netherlands, 5611 NJ
        • Pfizer Investigational Site
      • Rotterdam, Netherlands, 3001 HG
        • Pfizer Investigational Site
    • Dr
      • Emmen, Dr, Netherlands, 7824 AA
        • Pfizer Investigational Site
    • GA
      • Nijmegen, GA, Netherlands, 6525
        • Pfizer Investigational Site
    • HV
      • Amsterdam, HV, Netherlands, 1081
        • Pfizer Investigational Site
    • SZ
      • Nijmegen, SZ, Netherlands, 6532
        • 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
  • Norway
      • Bergen, Norway, NO-5094
        • Pfizer Investigational Site
      • Hamar, Norway, 2317
        • Pfizer Investigational Site
      • Oslo, Norway, NO-0164
        • Pfizer Investigational Site
      • Oslo, Norway, NO-0176
        • Pfizer Investigational Site
      • Trondheim, Norway, 7006
        • Pfizer Investigational Site
      • Trondheim, Norway, NO-7006
        • Pfizer Investigational Site
  • Poland
      • Katowice, Poland, 40-084
        • Pfizer Investigational Site
      • Krakow, Poland, 30-017
        • Pfizer Investigational Site
      • Krakow, Poland, 31-501
        • Pfizer Investigational Site
      • Krakow, Poland, 30-007
        • Pfizer Investigational Site
      • Krakow, Poland, 30-224
        • Pfizer Investigational Site
      • Krakow, Poland, 30-510
        • Pfizer Investigational Site
      • Lublin, Poland, 20-090
        • Pfizer Investigational Site
      • Warszawa, Poland, 00-909
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-341
        • Pfizer Investigational Site
      • Warszawa, Poland, 04-730
        • Pfizer Investigational Site
      • Warszawa, Poland, 00-315
        • Pfizer Investigational Site
      • Warszawa, Poland, 00-418
        • Pfizer Investigational Site
      • Warszawa, Poland, 00-655
        • Pfizer Investigational Site
      • Warszawa, Poland, 00-699
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-796
        • Pfizer Investigational Site
      • Warszawa, Poland, 03-335
        • Pfizer Investigational Site
      • Wroclaw, Poland, 50-088
        • Pfizer Investigational Site
  • Romania
      • Bucharest, Romania, 7000
        • Pfizer Investigational Site
      • Bucharesti, Romania, 7000
        • Pfizer Investigational Site
      • Bucuresti, Romania, 050521
        • Pfizer Investigational Site
      • Bucuresti, Romania, 70231
        • Pfizer Investigational Site
      • Cluj-Napoca, Romania, 400349
        • Pfizer Investigational Site
      • Iasi, Romania, 700111
        • Pfizer Investigational Site
    • Napoca
      • Cluj-, Napoca, Romania, 400000
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 115522
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 119002
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 117036
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 101990
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 107014
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 121356
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 127299
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 129010
        • Pfizer Investigational Site
      • Saint Petersburg, Russian Federation, 190068
        • Pfizer Investigational Site
      • St Petersburg, Russian Federation, 194291
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 199034
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 1190068
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 190068
        • Pfizer Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 826 06
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 83301
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 851 07
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 833 01
        • Pfizer Investigational Site
    • Slovak Republic
      • Piestany, Slovak Republic, Slovakia
        • Pfizer Investigational Site
  • South Africa
      • Bedford Gardens, South Africa
        • Pfizer Investigational Site
      • Johannesburg, South Africa, 2193
        • Pfizer Investigational Site
      • Johannesburg, South Africa, 2196
        • Pfizer Investigational Site
      • Johannesburg 2193, South Africa
        • Pfizer Investigational Site
      • Johannesburg, 2193, South Africa
        • Pfizer Investigational Site
      • Parow, South Africa, 7500
        • Pfizer Investigational Site
      • Parow 7500, South Africa
        • Pfizer Investigational Site
      • Pretoria, South Africa, 0181
        • Pfizer Investigational Site
      • Pretoria, South Africa, 0042
        • Pfizer Investigational Site
      • Pretoria, 0042, South Africa
        • Pfizer Investigational Site
      • Pretoria, 0181, South Africa
        • Pfizer Investigational Site
      • Somerset West, South Africa
        • Pfizer Investigational Site
      • Somerset West, 7129, South Africa
        • Pfizer Investigational Site
      • Somerset West, 7130, South Africa
        • Pfizer Investigational Site
      • Stellenbosch 7600, South Africa
        • Pfizer Investigational Site
    • Pretoria
      • Groenkloof, 0181, Pretoria, South Africa
        • Pfizer Investigational Site
  • Spain
      • Madrid, Spain, 28006
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
      • Madrid, Spain, 28046
        • Pfizer Investigational Site
      • Madrid, Spain, 28009
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35249-7201
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35294-3708
        • Pfizer Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Pfizer Investigational Site
      • Mobile, Alabama, United States, 36608
        • Pfizer Investigational Site
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85016
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85050
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85013
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85020
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85007
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85027
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85015
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85013-3903
        • Pfizer Investigational Site
      • Scottsdale, Arizona, United States, 85251
        • Pfizer Investigational Site
      • Scottsdale, Arizona, United States, 85254
        • Pfizer Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Pfizer Investigational Site
      • Berkeley, California, United States, 94705
        • Pfizer Investigational Site
      • Beverly Hills, California, United States, 90211
        • Pfizer Investigational Site
      • Fresno, California, United States, 93720
        • Pfizer Investigational Site
      • Fresno, California, United States, 93710
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • Oakland, California, United States, 94612
        • Pfizer Investigational Site
      • Palm Desert, California, United States, 92260
        • Pfizer Investigational Site
      • Palm Springs, California, United States, 92262
        • Pfizer Investigational Site
      • Palm Springs, California, United States, 92263
        • Pfizer Investigational Site
      • Palm Springs, California, United States, 92260
        • Pfizer Investigational Site
      • Rancho Mirage, California, United States, 92270
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95817
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95825
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95816
        • Pfizer Investigational Site
      • San Diego, California, United States, 92108
        • Pfizer Investigational Site
      • San Diego, California, United States, 92120
        • Pfizer Investigational Site
      • Upland, California, United States, 91786
        • Pfizer Investigational Site
      • Whittier, California, United States, 90602
        • Pfizer Investigational Site
    • Colorado
      • Lakewood, Colorado, United States, 80227
        • Pfizer Investigational Site
      • Longmont, Colorado, United States, 80501
        • Pfizer Investigational Site
      • Wheat Ridge, Colorado, United States, 80033
        • Pfizer Investigational Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Pfizer Investigational Site
      • Hamden, Connecticut, United States, 06518
        • Pfizer Investigational Site
      • Madison, Connecticut, United States, 06443
        • Pfizer Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Pfizer Investigational Site
      • Washington, District of Columbia, United States, 20007-2197
        • Pfizer Investigational Site
      • Washington, District of Columbia, United States, 20007
        • Pfizer Investigational Site
      • Washington, District of Columbia, United States, 20006
        • Pfizer Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Pfizer Investigational Site
      • Boca Raton, Florida, United States, 33432
        • Pfizer Investigational Site
      • Cape Coral, Florida, United States, 33990
        • Pfizer Investigational Site
      • Clearwater, Florida, United States, 33761
        • Pfizer Investigational Site
      • Daytona Beach, Florida, United States, 32114
        • Pfizer Investigational Site
      • Daytona Beach, Florida, United States, 32117
        • Pfizer Investigational Site
      • Delray Beach, Florida, United States, 33484
        • Pfizer Investigational Site
      • Fort Myers, Florida, United States, 33919
        • Pfizer Investigational Site
      • Ft. Myers, Florida, United States, 33916
        • Pfizer Investigational Site
      • Gainesville, Florida, United States, 32601
        • Pfizer Investigational Site
      • Holiday, Florida, United States, 34690
        • Pfizer Investigational Site
      • Lake Worth, Florida, United States, 33461
        • Pfizer Investigational Site
      • Largo, Florida, United States, 33773
        • Pfizer Investigational Site
      • Ormond Beach, Florida, United States, 32174
        • Pfizer Investigational Site
      • Palm Beach Gardens, Florida, United States, 33410
        • Pfizer Investigational Site
      • Palm Harbor, Florida, United States, 34684
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, United States, 33027
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, United States, 33029
        • Pfizer Investigational Site
      • Plantation, Florida, United States, 33324
        • Pfizer Investigational Site
      • Port Orange, Florida, United States, 32127
        • Pfizer Investigational Site
      • Sarasota, Florida, United States, 34239
        • Pfizer Investigational Site
      • Sarasota, Florida, United States, 34231
        • Pfizer Investigational Site
      • St Petersburg, Florida, United States, 33710
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33417
        • Pfizer Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
      • Riverdale, Georgia, United States, 30274
        • Pfizer Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Pfizer Investigational Site
      • Boise, Idaho, United States, 83702
        • Pfizer Investigational Site
      • Boise, Idaho, United States, 83712
        • Pfizer Investigational Site
      • Cadwell, Idaho, United States, 83605
        • Pfizer Investigational Site
      • Idaho Falls, Idaho, United States, 83404
        • Pfizer Investigational Site
      • Meridian, Idaho, United States, 83642
        • Pfizer Investigational Site
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
      • Libertyville, Illinois, United States, 60048
        • Pfizer Investigational Site
      • Peoria, Illinois, United States, 61614
        • Pfizer Investigational Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Pfizer Investigational Site
      • Evansville, Indiana, United States, 47714
        • Pfizer Investigational Site
      • Evansville, Indiana, United States, 47712
        • Pfizer Investigational Site
      • Evansville, Indiana, United States, 47750
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160-7136
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40291
        • Pfizer Investigational Site
      • Lousiville, Kentucky, United States, 40291
        • Pfizer Investigational Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Pfizer Investigational Site
      • Bangor, Maine, United States, 4401
        • Pfizer Investigational Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Pfizer Investigational Site
      • Silver Spring, Maryland, United States, 20902
        • Pfizer Investigational Site
      • Wheaton, Maryland, United States, 20902
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
      • Brookline, Massachusetts, United States, 02445
        • Pfizer Investigational Site
      • Fall River, Massachusetts, United States, 02720
        • Pfizer Investigational Site
      • Fall River, Massachusetts, United States, 02721
        • Pfizer Investigational Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Pfizer Investigational Site
      • Grand Rapids, Michigan, United States, 49503
        • Pfizer Investigational Site
      • Kalamazaoo, Michigan, United States, 49048
        • Pfizer Investigational Site
      • Kalamazoo, Michigan, United States, 49048
        • Pfizer Investigational Site
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Pfizer Investigational Site
      • Robbinsdale, Minnesota, United States, 55422
        • Pfizer Investigational Site
      • Shoreview, Minnesota, United States, 55126
        • Pfizer Investigational Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Pfizer Investigational Site
      • Jackson, Mississippi, United States, 39216
        • Pfizer Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Pfizer Investigational Site
      • St Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Pfizer Investigational Site
      • Bozeman, Montana, United States, 59715
        • Pfizer Investigational Site
      • Missoula, Montana, United States, 59801
        • Pfizer Investigational Site
      • Missoula, Montana, United States, 59804
        • Pfizer Investigational Site
      • Missoula, Montana, United States, 59802
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Pfizer Investigational Site
      • North Las Vegas, Nevada, United States, 89030
        • Pfizer Investigational Site
      • Reno, Nevada, United States, 89503
        • Pfizer Investigational Site
      • Reno, Nevada, United States, 89502-1196
        • Pfizer Investigational Site
    • New Jersey
      • Manchester Twp, New Jersey, United States, 08759
        • Pfizer Investigational Site
      • Ocean, New Jersey, United States, 07712
        • Pfizer Investigational Site
      • Princeton, New Jersey, United States, 08542
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Pfizer Investigational Site
      • Albuquerque, New Mexico, United States, 87109
        • Pfizer Investigational Site
      • Albuquerque, New Mexico, United States, 87106
        • Pfizer Investigational Site
    • New York
      • Bronx, New York, United States, 10461
        • Pfizer Investigational Site
      • New Hyde Park, New York, United States, 11042
        • Pfizer Investigational Site
      • New York, New York, United States, 10029
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28207
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28209
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Pfizer Investigational Site
      • Bismark, North Dakota, United States, 58501
        • Pfizer Investigational Site
      • Bismark, North Dakota, United States, 58503
        • Pfizer Investigational Site
      • Fargo, North Dakota, United States, 58103
        • Pfizer Investigational Site
      • Fargo, North Dakota, United States, 58104
        • Pfizer Investigational Site
      • Jamestown, North Dakota, United States, 58401
        • Pfizer Investigational Site
      • Minot, North Dakota, United States, 58701
        • Pfizer Investigational Site
      • Minot, North Dakota, United States, 58702
        • Pfizer Investigational Site
      • Oakes, North Dakota, United States, 58574
        • Pfizer Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44312-1647
        • Pfizer Investigational Site
      • Akron, Ohio, United States, 44313
        • Pfizer Investigational Site
      • Centerville, Ohio, United States, 45459
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45249
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45236
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44122
        • Pfizer Investigational Site
      • Kettering, Ohio, United States, 45459
        • Pfizer Investigational Site
      • Lyndhurst, Ohio, United States, 44124
        • Pfizer Investigational Site
      • Mayfield Village, Ohio, United States, 44143
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma, Oklahoma, United States, 73102
        • Pfizer Investigational Site
      • Oklahoma, Oklahoma, United States, 73120
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73112-4481
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73142
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74135
        • Pfizer Investigational Site
      • Yukon, Oklahoma, United States, 73099
        • Pfizer Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Pfizer Investigational Site
      • Camp Hill, Pennsylvania, United States, 17011
        • Pfizer Investigational Site
      • Duncansville, Pennsylvania, United States, 16635
        • Pfizer Investigational Site
      • Johnstown, Pennsylvania, United States, 15904
        • Pfizer Investigational Site
      • Langhome, Pennsylvania, United States, 19047
        • Pfizer Investigational Site
      • Lemoyne, Pennsylvania, United States, 17043
        • Pfizer Investigational Site
      • Newtown, Pennsylvania, United States, 18940
        • Pfizer Investigational Site
      • Sellersville, Pennsylvania, United States, 18960
        • Pfizer Investigational Site
      • West Reading, Pennsylvania, United States, 19611
        • Pfizer Investigational Site
      • Wyomissing, Pennsylvania, United States, 19610
        • Pfizer Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Pfizer Investigational Site
      • Belton, South Carolina, United States, 29627
        • Pfizer Investigational Site
      • Mt. Pleasant, South Carolina, United States, 29464
        • Pfizer Investigational Site
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Pfizer Investigational Site
      • Sioux Falls, South Dakota, United States, 57105
        • Pfizer Investigational Site
      • Waterdown, South Dakota, United States, 57201
        • Pfizer Investigational Site
      • Watertown, South Dakota, United States, 57201
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38104
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38120
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38138
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
    • Texas
      • Bellaire, Texas, United States, 77401
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75243
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75230-2513
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229-3894
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78220
        • Pfizer Investigational Site
      • Temple, Texas, United States, 76504
        • Pfizer Investigational Site
      • Waco, Texas, United States, 76708
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84102-3015
        • Pfizer Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Pfizer Investigational Site
      • Virginia Beach, Virginia, United States, 23454
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98195
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98133
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98105-4631
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98105
        • Pfizer Investigational Site
      • Spokane, Washington, United States, 99204
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Pfizer Investigational Site
      • Milwaukee, Wisconsin, United States, 53209
        • Pfizer Investigational Site
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: Bazedoxifene Acetate
BZA 20mg, daily, oral
Placebo Comparator: B
Other: Placebo
Placebo, daily, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With New Vertebral Fractures Through Month 36
Time Frame: 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
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Breast Cancer Through Month 36
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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]
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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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Sponsor

Pfizer

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Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

April 10, 2013

Last Update Submitted That Met QC Criteria

February 28, 2013

Last Verified

February 1, 2013

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Other Study ID Numbers

  • 3068A1-301
  • B1781001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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