Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

NCT00205777 | Completed Phase 3 Results

• 2 other identifiers: 3068A1-301B1781001
• Study Type: interventional
• Target: 7,609
• Locations: 28 countries
• Sites: 366

Brief Summary

The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.

Conditions

Osteoporosis

Keywords

Osteoporosis; Postmenopause

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With New Vertebral Fractures 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

  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

  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 Outcomes (57)

• Incidence of Breast Cancer Through Month 36

  Baseline through Month 36

• Incidence of Breast Cancer Through Month 60

  Baseline through Month 60

• Incidence of Breast Cancer Through Month 84

  Baseline through Month 84

• Percentage of Participants With New Clinical Vertebral Fractures Through Month 36

  Baseline through Month 36

• Percentage of Participants With New Clinical Vertebral Fractures Through Month 60

  Baseline through Month 60

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: Bazedoxifene Acetate

B

PLACEBO COMPARATOR

Other: Placebo

Interventions

Bazedoxifene Acetate DRUG

BZA 20mg, daily, oral

A

Placebo OTHER

Placebo, daily, oral

B

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 2 years postmenopausal
• Osteoporotic subjects without vertebral fracture who meet BMD criteria, or Osteoporotic subjects with vertebral fracture

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (375)

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35249-7201, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35294-3708, United States

Location

Pfizer Investigational Site

Huntsville, Alabama, 35801, United States

Location

Pfizer Investigational Site

Mobile, Alabama, 36608, United States

Location

Pfizer Investigational Site

Glendale, Arizona, 85306, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85007, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85013-3903, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85013, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85015, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85016, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85020, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85027, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85050, United States

Location

Pfizer Investigational Site

Scottsdale, Arizona, 85251, United States

Location

Pfizer Investigational Site

Scottsdale, Arizona, 85254, United States

Location

Pfizer Investigational Site

Anaheim, California, 92801, United States

Location

Pfizer Investigational Site

Berkeley, California, 94705, United States

Location

Pfizer Investigational Site

Beverly Hills, California, 90211, United States

Location

Pfizer Investigational Site

Fresno, California, 93710, United States

Location

Pfizer Investigational Site

Fresno, California, 93720, United States

Location

Pfizer Investigational Site

La Jolla, California, 92037, United States

Location

Pfizer Investigational Site

Oakland, California, 94612, United States

Location

Pfizer Investigational Site

Palm Desert, California, 92260, United States

Location

Pfizer Investigational Site

Palm Springs, California, 92260, United States

Location

Pfizer Investigational Site

Palm Springs, California, 92262, United States

Location

Pfizer Investigational Site

Palm Springs, California, 92263, United States

Location

Pfizer Investigational Site

Rancho Mirage, California, 92270, United States

Location

Pfizer Investigational Site

Sacramento, California, 95816, United States

Location

Pfizer Investigational Site

Sacramento, California, 95817, United States

Location

Pfizer Investigational Site

Sacramento, California, 95825, United States

Location

Pfizer Investigational Site

San Diego, California, 92108, United States

Location

Pfizer Investigational Site

San Diego, California, 92120, United States

Location

Pfizer Investigational Site

Upland, California, 91786, United States

Location

Pfizer Investigational Site

Whittier, California, 90602, United States

Location

Pfizer Investigational Site

Lakewood, Colorado, 80227, United States

Location

Pfizer Investigational Site

Longmont, Colorado, 80501, United States

Location

Pfizer Investigational Site

Wheat Ridge, Colorado, 80033, United States

Location

Pfizer Investigational Site

Bridgeport, Connecticut, 06606, United States

Location

Pfizer Investigational Site

Hamden, Connecticut, 06518, United States

Location

Pfizer Investigational Site

Madison, Connecticut, 06443, United States

Location

Pfizer Investigational Site

Waterbury, Connecticut, 06708, United States

Location

Pfizer Investigational Site

Newark, Delaware, 19713, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20006, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20007-2197, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20007, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20037, United States

Location

Pfizer Investigational Site

Aventura, Florida, 33180, United States

Location

Pfizer Investigational Site

Boca Raton, Florida, 33432, United States

Location

Pfizer Investigational Site

Cape Coral, Florida, 33990, United States

Location

Pfizer Investigational Site

Clearwater, Florida, 33761, United States

Location

Pfizer Investigational Site

Daytona Beach, Florida, 32114, United States

Location

Pfizer Investigational Site

Daytona Beach, Florida, 32117, United States

Location

Pfizer Investigational Site

Delray Beach, Florida, 33484, United States

Location

Pfizer Investigational Site

Fort Myers, Florida, 33916, United States

Location

Pfizer Investigational Site

Fort Myers, Florida, 33919, United States

Location

Pfizer Investigational Site

Gainesville, Florida, 32601, United States

Location

Pfizer Investigational Site

Holiday, Florida, 34690, United States

Location

Pfizer Investigational Site

Lake Worth, Florida, 33461, United States

Location

Pfizer Investigational Site

Largo, Florida, 33773, United States

Location

Pfizer Investigational Site

Ormond Beach, Florida, 32174, United States

Location

Pfizer Investigational Site

Palm Beach Gardens, Florida, 33410, United States

Location

Pfizer Investigational Site

Palm Harbor, Florida, 34684, United States

Location

Pfizer Investigational Site

Pembroke Pines, Florida, 33027, United States

Location

Pfizer Investigational Site

Pembroke Pines, Florida, 33029, United States

Location

Pfizer Investigational Site

Plantation, Florida, 33324, United States

Location

Pfizer Investigational Site

Port Orange, Florida, 32127, United States

Location

Pfizer Investigational Site

Sarasota, Florida, 34231, United States

Location

Pfizer Investigational Site

Sarasota, Florida, 34239, United States

Location

Pfizer Investigational Site

St. Petersburg, Florida, 33710, United States

Location

Pfizer Investigational Site

West Palm Beach, Florida, 33401, United States

Location

Pfizer Investigational Site

West Palm Beach, Florida, 33407, United States

Location

Pfizer Investigational Site

West Palm Beach, Florida, 33409, United States

Location

Pfizer Investigational Site

West Palm Beach, Florida, 33417, United States

Location

Pfizer Investigational Site

Augusta, Georgia, 30909, United States

Location

Pfizer Investigational Site

Decatur, Georgia, 30033, United States

Location

Pfizer Investigational Site

Riverdale, Georgia, 30274, United States

Location

Pfizer Investigational Site

Boise, Idaho, 83702, United States

Location

Pfizer Investigational Site

Boise, Idaho, 83704, United States

Location

Pfizer Investigational Site

Boise, Idaho, 83712, United States

Location

Pfizer Investigational Site

Cadwell, Idaho, 83605, United States

Location

Pfizer Investigational Site

Idaho Falls, Idaho, 83404, United States

Location

Pfizer Investigational Site

Meridian, Idaho, 83642, United States

Location

Pfizer Investigational Site

Champaign, Illinois, 61820, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60612, United States

Location

Pfizer Investigational Site

Libertyville, Illinois, 60048, United States

Location

Pfizer Investigational Site

Peoria, Illinois, 61614, United States

Location

Pfizer Investigational Site

Avon, Indiana, 46123, United States

Location

Pfizer Investigational Site

Evansville, Indiana, 47712, United States

Location

Pfizer Investigational Site

Evansville, Indiana, 47714, United States

Location

Pfizer Investigational Site

Evansville, Indiana, 47750, United States

Location

Pfizer Investigational Site

Kansas City, Kansas, 66160-7136, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40207, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40291, United States

Location

Pfizer Investigational Site

Lousiville, Kentucky, 40291, United States

Location

Pfizer Investigational Site

Bangor, Maine, 04401, United States

Location

Pfizer Investigational Site

Bangor, Maine, 4401, United States

Location

Pfizer Investigational Site

Bethesda, Maryland, 20817, United States

Location

Pfizer Investigational Site

Silver Spring, Maryland, 20902, United States

Location

Pfizer Investigational Site

Wheaton, Maryland, 20902, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02115, United States

Location

Pfizer Investigational Site

Brookline, Massachusetts, 02445, United States

Location

Pfizer Investigational Site

Fall River, Massachusetts, 02720, United States

Location

Pfizer Investigational Site

Fall River, Massachusetts, 02721, United States

Location

Pfizer Investigational Site

Grand Rapids, Michigan, 49503, United States

Location

Pfizer Investigational Site

Grand Rapids, Michigan, 49546, United States

Location

Pfizer Investigational Site

Kalamazaoo, Michigan, 49048, United States

Location

Pfizer Investigational Site

Kalamazoo, Michigan, 49048, United States

Location

Pfizer Investigational Site

Brooklyn Center, Minnesota, 55430, United States

Location

Pfizer Investigational Site

Robbinsdale, Minnesota, 55422, United States

Location

Pfizer Investigational Site

Shoreview, Minnesota, 55126, United States

Location

Pfizer Investigational Site

Flowood, Mississippi, 39232, United States

Location

Pfizer Investigational Site

Jackson, Mississippi, 39216, United States

Location

Pfizer Investigational Site

Jefferson City, Missouri, 65109, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63141, United States

Location

Pfizer Investigational Site

Billings, Montana, 59101, United States

Location

Pfizer Investigational Site

Bozeman, Montana, 59715, United States

Location

Pfizer Investigational Site

Missoula, Montana, 59801, United States

Location

Pfizer Investigational Site

Missoula, Montana, 59802, United States

Location

Pfizer Investigational Site

Missoula, Montana, 59804, United States

Location

Pfizer Investigational Site

Lincoln, Nebraska, 68510, United States

Location

Pfizer Investigational Site

Henderson, Nevada, 89014, United States

Location

Pfizer Investigational Site

North Las Vegas, Nevada, 89030, United States

Location

Pfizer Investigational Site

Reno, Nevada, 89502-1196, United States

Location

Pfizer Investigational Site

Reno, Nevada, 89503, United States

Location

Pfizer Investigational Site

Manchester Twp, New Jersey, 08759, United States

Location

Pfizer Investigational Site

Ocean City, New Jersey, 07712, United States

Location

Pfizer Investigational Site

Princeton, New Jersey, 08542, United States

Location

Pfizer Investigational Site

Albuquerque, New Mexico, 87102, United States

Location

Pfizer Investigational Site

Albuquerque, New Mexico, 87106, United States

Location

Pfizer Investigational Site

Albuquerque, New Mexico, 87109, United States

Location

Pfizer Investigational Site

New Hyde Park, New York, 11042, United States

Location

Pfizer Investigational Site

New York, New York, 10029, United States

Location

Pfizer Investigational Site

The Bronx, New York, 10461, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28207, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28209, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28277, United States

Location

Pfizer Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Pfizer Investigational Site

Bismarck, North Dakota, 58501, United States

Location

Pfizer Investigational Site

Bismarck, North Dakota, 58503, United States

Location

Pfizer Investigational Site

Fargo, North Dakota, 58103, United States

Location

Pfizer Investigational Site

Fargo, North Dakota, 58104, United States

Location

Pfizer Investigational Site

Jamestown, North Dakota, 58401, United States

Location

Pfizer Investigational Site

Minot, North Dakota, 58701, United States

Location

Pfizer Investigational Site

Minot, North Dakota, 58702, United States

Location

Pfizer Investigational Site

Oakes, North Dakota, 58574, United States

Location

Pfizer Investigational Site

Akron, Ohio, 44312-1647, United States

Location

Pfizer Investigational Site

Akron, Ohio, 44313, United States

Location

Pfizer Investigational Site

Centerville, Ohio, 45459, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45236, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45249, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44122, United States

Location

Pfizer Investigational Site

Kettering, Ohio, 45459, United States

Location

Pfizer Investigational Site

Lyndhurst, Ohio, 44124, United States

Location

Pfizer Investigational Site

Mayfield Village, Ohio, 44143, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73102, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73112-4481, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73120, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73142, United States

Location

Pfizer Investigational Site

Tulsa, Oklahoma, 74135, United States

Location

Pfizer Investigational Site

Yukon, Oklahoma, 73099, United States

Location

Pfizer Investigational Site

Altoona, Pennsylvania, 16602, United States

Location

Pfizer Investigational Site

Camp Hill, Pennsylvania, 17011, United States

Location

Pfizer Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

Pfizer Investigational Site

Johnstown, Pennsylvania, 15904, United States

Location

Pfizer Investigational Site

Langhome, Pennsylvania, 19047, United States

Location

Pfizer Investigational Site

Lemoyne, Pennsylvania, 17043, United States

Location

Pfizer Investigational Site

Newtown, Pennsylvania, 18940, United States

Location

Pfizer Investigational Site

Sellersville, Pennsylvania, 18960, United States

Location

Pfizer Investigational Site

West Reading, Pennsylvania, 19611, United States

Location

Pfizer Investigational Site

Wyomissing, Pennsylvania, 19610, United States

Location

Pfizer Investigational Site

Anderson, South Carolina, 29621, United States

Location

Pfizer Investigational Site

Belton, South Carolina, 29627, United States

Location

Pfizer Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

Pfizer Investigational Site

Aberdeen, South Dakota, 57401, United States

Location

Pfizer Investigational Site

Sioux Falls, South Dakota, 57105, United States

Location

Pfizer Investigational Site

Waterdown, South Dakota, 57201, United States

Location

Pfizer Investigational Site

Watertown, South Dakota, 57201, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38104, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38119, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38120, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38138, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37203, United States

Location

Pfizer Investigational Site

Bellaire, Texas, 77401, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75230-2513, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75230, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75231, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75243, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78220, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229-3894, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Temple, Texas, 76504, United States

Location

Pfizer Investigational Site

Waco, Texas, 76708, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84102-3015, United States

Location

Pfizer Investigational Site

Norfolk, Virginia, 23502, United States

Location

Pfizer Investigational Site

Virginia Beach, Virginia, 23454, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98105-4631, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98105, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98133, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98195, United States

Location

Pfizer Investigational Site

Spokane, Washington, 99204, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, 53209, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, 53226, United States

Location

Pfizer Investigational Site

Cheyenne, Wyoming, 82001, United States

Location

Pfizer Investigational Site

Provincia de Buenos Aires, Argentina

Location

Pfizer Investigational Site

Concord, New South Wales, 2139, Australia

Location

Pfizer Investigational Site

St Leonards, New South Wales, 2065, Australia

Location

Pfizer Investigational Site

Nedlands, Western Australia, 6009, Australia

Location

Pfizer Investigational Site

Herston, QLD 4029, Australia

Location

Pfizer Investigational Site

Keswick, Australia

Location

Pfizer Investigational Site

Graz, 8036, Austria

Location

Pfizer Investigational Site

Ghent, Belgium, 9000, Belgium

Location

Pfizer Investigational Site

Liège, Liege, 4000, Belgium

Location

Pfizer Investigational Site

Diepenbeek, 3590, Belgium

Location

Pfizer Investigational Site

Genk, 3600, Belgium

Location

Pfizer Investigational Site

Leuven, 3000, Belgium

Location

Pfizer Investigational Site

Schiepsebos, 6, Belgium

Location

Pfizer Investigational Site

Goiânia, Goiás, 74175-080, Brazil

Location

Pfizer Investigational Site

Duque de Caxias - Cuiaba, Mato Grosso, 78043-306, Brazil

Location

Pfizer Investigational Site

Rio de Janeiro, Rio de Janeiro, 20020-020, Brazil

Location

Pfizer Investigational Site

Rio de Janeiro, Rio de Janeiro, 22271-100, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04020-060, Brazil

Location

Pfizer Investigational Site

Sorocaba, São Paulo, 18095-450, Brazil

Location

Pfizer Investigational Site

Plovdiv, Bulgaria, 4002, Bulgaria

Location

Pfizer Investigational Site

Sofia, Bulgaria, 1301, Bulgaria

Location

Pfizer Investigational Site

Sofia, Bulgaria, 1431, Bulgaria

Location

Pfizer Investigational Site

Sofia, Bulgaria, 1504, Bulgaria

Location

Pfizer Investigational Site

Pleven, 5800, Bulgaria

Location

Pfizer Investigational Site

Plovdiv, 4002, Bulgaria

Location

Pfizer Investigational Site

Sofia, 1301, Bulgaria

Location

Pfizer Investigational Site

Sofia, 1303, Bulgaria

Location

Pfizer Investigational Site

Sofia, 1407, Bulgaria

Location

Pfizer Investigational Site

Sofia, 1431, Bulgaria

Location

Pfizer Investigational Site

Sofia, 1504, Bulgaria

Location

Pfizer Investigational Site

Calgary, Alberta, T2N 4Z6, Canada

Location

Pfizer Investigational Site

Vancouver, British Columbia, V5Z 2N6, Canada

Location

Pfizer Investigational Site

Vancouver, British Columbia, V6H 3X8, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3A 1M3, Canada

Location

Pfizer Investigational Site

Hamilton, Ontario, L8N 1Y2, Canada

Location

Pfizer Investigational Site

Hawkesbury, Ontario, K6A 1A1, Canada

Location

Pfizer Investigational Site

Hawkesbury, Ontario, K6A 3B2, Canada

Location

Pfizer Investigational Site

London, Ontario, N6A 4V2, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M5C 1R6, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M5C 2T2, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M5G 1E2, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, MB5 1W8, Canada

Location

Pfizer Investigational Site

Gatineau, Quebec, J8Y 6S9, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H2L 1S6, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H2X 1N8, Canada

Location

Pfizer Investigational Site

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Pfizer Investigational Site

Québec, Quebec, G1S 2L6, Canada

Location

Pfizer Investigational Site

Québec, Quebec, G1V 3M7, Canada

Location

Pfizer Investigational Site

Sherbrooke, Quebec, J1H 4J6, Canada

Location

Pfizer Investigational Site

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

Pfizer Investigational Site

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

Pfizer Investigational Site

Saskatoon, Saskatchewan, S7K 1N4, Canada

Location

Pfizer Investigational Site

Santiago, Chile

Location

Pfizer Investigational Site

Zadar, 23000, Croatia

Location

Pfizer Investigational Site

Zagreb, 10000, Croatia

Location

Pfizer Investigational Site

Aalborg, 9000, Denmark

Location

Pfizer Investigational Site

Ballerup Municipality, 2750, Denmark

Location

Pfizer Investigational Site

Vejle, 7100, Denmark

Location

Pfizer Investigational Site

Tallinn, 10128, Estonia

Location

Pfizer Investigational Site

Tartu, 50410, Estonia

Location

Pfizer Investigational Site

Tartu, 51010, Estonia

Location

Pfizer Investigational Site

Tartu, Estonia

Location

Pfizer Investigational Site

Oulu, Finland, 90 100, Finland

Location

Pfizer Investigational Site

Jyväskylä, FIN, 40100, Finland

Location

Pfizer Investigational Site

Jyväskylä, 40700, Finland

Location

Pfizer Investigational Site

Jyväskylä, FIN-40100, Finland

Location

Pfizer Investigational Site

Kuopio, 70210, Finland

Location

Pfizer Investigational Site

Kuopio, 70211, Finland

Location

Pfizer Investigational Site

Kuopio, FIN-70211, Finland

Location

Pfizer Investigational Site

Lahti, Finland

Location

Pfizer Investigational Site

Turku, 20100, Finland

Location

Pfizer Investigational Site

Lyon, 69437, France

Location

Pfizer Investigational Site

Orléans, 45032, France

Location

Pfizer Investigational Site

Paris, 75015, France

Location

Pfizer Investigational Site

Berlin, 12200, Germany

Location

Pfizer Investigational Site

München, 80809, Germany

Location

Pfizer Investigational Site

Zerbst, 39261, Germany

Location

Pfizer Investigational Site

Athens, Greece, 11526, Greece

Location

Pfizer Investigational Site

Hong Kong, Hong Kong

Location

Pfizer Investigational Site

PRC, Hong Kong

Location

Pfizer Investigational Site

Sai Ying Pung, Hong Kong

Location

Pfizer Investigational Site

Békéscsaba, 5600, Hungary

Location

Pfizer Investigational Site

H-6720 Szeged, Hungary

Location

Pfizer Investigational Site

Kecskemét, 6000, Hungary

Location

Pfizer Investigational Site

Makó, 6900, Hungary

Location

Pfizer Investigational Site

Roma, 00136, Italy

Location

Pfizer Investigational Site

Roma, 00168, Italy

Location

Pfizer Investigational Site

Roma, 00189, Italy

Location

Pfizer Investigational Site

Siena, 53100, Italy

Location

Pfizer Investigational Site

Kaunas, LT-50009, Lithuania

Location

Pfizer Investigational Site

Vilnius, LT-04130, Lithuania

Location

Pfizer Investigational Site

Vilnius, LT-10318, Lithuania

Location

Pfizer Investigational Site

Seccion de Lomas Verdes, State of Mexico, CP 53120, Mexico

Location

Pfizer Investigational Site

Mexico City, 03100, Mexico

Location

Pfizer Investigational Site

Mexico City, 11800, Mexico

Location

Pfizer Investigational Site

Emmen, Drenthe, 7824 AA, Netherlands

Location

Pfizer Investigational Site

Nijmegen, GA, 6525, Netherlands

Location

Pfizer Investigational Site

Amsterdam, HV, 1081, Netherlands

Location

Pfizer Investigational Site

Nijmegen, SZ, 6532, Netherlands

Location

Pfizer Investigational Site

Eindhoven, 5611 NJ, Netherlands

Location

Pfizer Investigational Site

Rotterdam, 3001 HG, Netherlands

Location

Pfizer Investigational Site

Milford, Auckland, New Zealand

Location

Pfizer Investigational Site

Christchurch, NZ, 8143, New Zealand

Location

Pfizer Investigational Site

Auckland, New Zealand

Location

Pfizer Investigational Site

Dunedin, New Zealand

Location

Pfizer Investigational Site

Bergen, NO-5094, Norway

Location

Pfizer Investigational Site

Hamar, 2317, Norway

Location

Pfizer Investigational Site

Oslo, NO-0164, Norway

Location

Pfizer Investigational Site

Oslo, NO-0176, Norway

Location

Pfizer Investigational Site

Trondheim, 7006, Norway

Location

Pfizer Investigational Site

Trondheim, NO-7006, Norway

Location

Pfizer Investigational Site

Krakow, Krakow, 30-510, Poland

Location

Pfizer Investigational Site

Katowice, Poland, 40-084, Poland

Location

Pfizer Investigational Site

Warsaw, Poland, 03-335, Poland

Location

Pfizer Investigational Site

Wroclaw, Poland, 50-088, Poland

Location

Pfizer Investigational Site

Krakow, 30-007, Poland

Location

Pfizer Investigational Site

Krakow, 30-017, Poland

Location

Pfizer Investigational Site

Krakow, 30-224, Poland

Location

Pfizer Investigational Site

Krakow, 31-501, Poland

Location

Pfizer Investigational Site

Lublin, 20-090, Poland

Location

Pfizer Investigational Site

Warsaw, 00-315, Poland

Location

Pfizer Investigational Site

Warsaw, 00-418, Poland

Location

Pfizer Investigational Site

Warsaw, 00-655, Poland

Location

Pfizer Investigational Site

Warsaw, 00-699, Poland

Location

Pfizer Investigational Site

Warsaw, 00-909, Poland

Location

Pfizer Investigational Site

Warsaw, 02-341, Poland

Location

Pfizer Investigational Site

Warsaw, 02-796, Poland

Location

Pfizer Investigational Site

Warsaw, 04-730, Poland

Location

Pfizer Investigational Site

Iași, Iaşi, 700111, Romania

Location

Pfizer Investigational Site

Cluj-Napoca, Napoca, 400000, Romania

Location

Pfizer Investigational Site

Bucharest, 050521, Romania

Location

Pfizer Investigational Site

Bucharest, 7000, Romania

Location

Pfizer Investigational Site

Bucharest, 70231, Romania

Location

Pfizer Investigational Site

Bucharesti, 7000, Romania

Location

Pfizer Investigational Site

Cluj-Napoca, 400349, Romania

Location

Pfizer Investigational Site

Moscow, 101990, Russia

Location

Pfizer Investigational Site

Moscow, 107014, Russia

Location

Pfizer Investigational Site

Moscow, 115522, Russia

Location

Pfizer Investigational Site

Moscow, 117036, Russia

Location

Pfizer Investigational Site

Moscow, 119002, Russia

Location

Pfizer Investigational Site

Moscow, 121356, Russia

Location

Pfizer Investigational Site

Moscow, 127299, Russia

Location

Pfizer Investigational Site

Moscow, 129010, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 1190068, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 190068, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 194291, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 199034, Russia

Location

Pfizer Investigational Site

Piešťany, Slovak Republic, Slovakia

Location

Pfizer Investigational Site

Bratislava, 826 06, Slovakia

Location

Pfizer Investigational Site

Bratislava, 833 01, Slovakia

Location

Pfizer Investigational Site

Bratislava, 83301, Slovakia

Location

Pfizer Investigational Site

Bratislava, 851 07, Slovakia

Location

Pfizer Investigational Site

Groenkloof, Pretoria, South Africa

Location

Pfizer Investigational Site

Johannesburg, South Africa, 2193, South Africa

Location

Pfizer Investigational Site

Pretoria, South Africa, 0181, South Africa

Location

Pfizer Investigational Site

Bedford Gardens, South Africa

Location

Pfizer Investigational Site

Johannesburg, 2193, South Africa

Location

Pfizer Investigational Site

Johannesburg, 2196, South Africa

Location

Pfizer Investigational Site

Johannesburg, South Africa

Location

Pfizer Investigational Site

Parow, 7500, South Africa

Location

Pfizer Investigational Site

Parow, South Africa

Location

Pfizer Investigational Site

Pretoria, 0042, South Africa

Location

Pfizer Investigational Site

Pretoria, South Africa

Location

Pfizer Investigational Site

Somerset West, South Africa

Location

Pfizer Investigational Site

Stellenbosch, South Africa

Location

Pfizer Investigational Site

Madrid, Madrid, 28046, Spain

Location

Pfizer Investigational Site

Madrid, Spain, 28009, Spain

Location

Pfizer Investigational Site

Madrid, 28006, Spain

Location

Pfizer Investigational Site

Madrid, 28009, Spain

Location

Pfizer Investigational Site

Madrid, 28040, Spain

Location

Related Publications (1)

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

  PMID: 20569451 DERIVED

Related Links

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

MeSH Terms

Conditions

Osteoporosis

Interventions

bazedoxifene

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 20, 2005
• Study Start: December 1, 2001
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 10, 2013
• Results First Posted: April 10, 2013

Record last verified: 2013-02

Locations

GR (1); AR (1); DK (3); HU (4); DE (3); HK (3); ME (3); NO (6); CR (2); BU (11); FI (9); ES (5); AU (1); BE (6); FR (3); RO (7); US (205); IT (4); NZ (4); CA (22); CL (1); ZA (13); NL (6); LI (3); PL (17); RU (12); BR (6); SL (5)