Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205777
• Other study ID #: 3068A1-301
• Secondary ID: B1781001
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2005
• Last updated: February 28, 2013
• Start date: December 2001
• Est. completion date: September 2010

Study information

• Verified date: February 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7609
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Bazedoxifene Acetate
BZA 20mg, daily, oral

Other:
• Placebo
Placebo, daily, oral

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Provincia de Buenos Aires
Australia	Pfizer Investigational Site	Concord	New South Wales
Australia	Pfizer Investigational Site	Herston
Australia	Pfizer Investigational Site	Keswick
Australia	Pfizer Investigational Site	Nedlands	Western Australia
Australia	Pfizer Investigational Site	St Leonards	New South Wales
Austria	Pfizer Investigational Site	Graz
Belgium	Pfizer Investigational Site	Diepenbeek
Belgium	Pfizer Investigational Site	Genk
Belgium	Pfizer Investigational Site	Gent
Belgium	Pfizer Investigational Site	Leuven
Belgium	Pfizer Investigational Site	Liege
Belgium	Pfizer Investigational Site	Schiepsebos
Brazil	Pfizer Investigational Site	Duque de Caxias - Cuiaba	MT
Brazil	Pfizer Investigational Site	Goiania	GO
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	São Paulo	SP
Brazil	Pfizer Investigational Site	Sorocaba	Sao Paulo
Bulgaria	Pfizer Investigational Site	Pleven
Bulgaria	Pfizer Investigational Site	Plovdiv
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Gatineau	Quebec
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	Hawkesbury	Ontario
Canada	Pfizer Investigational Site	Hawkesbury	Ontario
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Pointe-Claire	Quebec
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Saskatoon	Saskatchewan
Canada	Pfizer Investigational Site	Saskatoon	Saskatchewan
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Trois-Rivieres	Quebec
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Chile	Pfizer Investigational Site	Santiago
Croatia	Pfizer Investigational Site	Zadar
Croatia	Pfizer Investigational Site	Zagreb
Denmark	Pfizer Investigational Site	Aalborg
Denmark	Pfizer Investigational Site	Ballerup
Denmark	Pfizer Investigational Site	Vejle
Estonia	Pfizer Investigational Site	Tallinn
Estonia	Pfizer Investigational Site	Tartu
Estonia	Pfizer Investigational Site	Tartu
Estonia	Pfizer Investigational Site	Tartu
Finland	Pfizer Investigational Site	Jyvaskyla	FIN
Finland	Pfizer Investigational Site	Jyvaskyla
Finland	Pfizer Investigational Site	Jyväskylä
Finland	Pfizer Investigational Site	Kuopio
Finland	Pfizer Investigational Site	Kuopio
Finland	Pfizer Investigational Site	Kuopio
Finland	Pfizer Investigational Site	Lahti
Finland	Pfizer Investigational Site	Oulu
Finland	Pfizer Investigational Site	Turku
France	Pfizer Investigational Site	Lyon Cedex 03
France	Pfizer Investigational Site	Orleans cedex 1
France	Pfizer Investigational Site	Paris
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Zerbst
Greece	Pfizer Investigational Site	Athens
Hong Kong	Pfizer Investigational Site	Hong Kong
Hong Kong	Pfizer Investigational Site	PRC
Hong Kong	Pfizer Investigational Site	Sai Ying Pung
Hungary	Pfizer Investigational Site	Bekescsaba
Hungary	Pfizer Investigational Site	H-6720 Szeged
Hungary	Pfizer Investigational Site	Kecskemet
Hungary	Pfizer Investigational Site	Mako
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Siena
Lithuania	Pfizer Investigational Site	Kaunas
Lithuania	Pfizer Investigational Site	Vilnius
Lithuania	Pfizer Investigational Site	Vilnius
Mexico	Pfizer Investigational Site	Mexico City
Mexico	Pfizer Investigational Site	Mexico D.F.
Mexico	Pfizer Investigational Site	seccion de Lomas Verdes	Estado de Mexico
Netherlands	Pfizer Investigational Site	Amsterdam	HV
Netherlands	Pfizer Investigational Site	Eindhoven
Netherlands	Pfizer Investigational Site	Emmen	Dr
Netherlands	Pfizer Investigational Site	Nijmegen	GA
Netherlands	Pfizer Investigational Site	Nijmegen	SZ
Netherlands	Pfizer Investigational Site	Rotterdam
New Zealand	Pfizer Investigational Site	Auckland
New Zealand	Pfizer Investigational Site	Christchurch	NZ
New Zealand	Pfizer Investigational Site	Dunedin
New Zealand	Pfizer Investigational Site	Milford	Auckland
Norway	Pfizer Investigational Site	Bergen
Norway	Pfizer Investigational Site	Hamar
Norway	Pfizer Investigational Site	Oslo
Norway	Pfizer Investigational Site	Oslo
Norway	Pfizer Investigational Site	Trondheim
Norway	Pfizer Investigational Site	Trondheim
Poland	Pfizer Investigational Site	Katowice
Poland	Pfizer Investigational Site	Krakow
Poland	Pfizer Investigational Site	Krakow
Poland	Pfizer Investigational Site	Krakow
Poland	Pfizer Investigational Site	Krakow
Poland	Pfizer Investigational Site	Krakow
Poland	Pfizer Investigational Site	Lublin
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Wroclaw
Romania	Pfizer Investigational Site	Bucharest
Romania	Pfizer Investigational Site	Bucharesti
Romania	Pfizer Investigational Site	Bucuresti
Romania	Pfizer Investigational Site	Bucuresti
Romania	Pfizer Investigational Site	Cluj-	Napoca
Romania	Pfizer Investigational Site	Cluj-Napoca
Romania	Pfizer Investigational Site	Iasi
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Saint Petersburg
Russian Federation	Pfizer Investigational Site	St Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Piestany	Slovak Republic
South Africa	Pfizer Investigational Site	Bedford Gardens
South Africa	Pfizer Investigational Site	Groenkloof, 0181	Pretoria
South Africa	Pfizer Investigational Site	Johannesburg
South Africa	Pfizer Investigational Site	Johannesburg
South Africa	Pfizer Investigational Site	Johannesburg 2193
South Africa	Pfizer Investigational Site	Johannesburg, 2193
South Africa	Pfizer Investigational Site	Parow
South Africa	Pfizer Investigational Site	Parow 7500
South Africa	Pfizer Investigational Site	Pretoria
South Africa	Pfizer Investigational Site	Pretoria
South Africa	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
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
United States	Pfizer Investigational Site	Aberdeen	South Dakota
United States	Pfizer Investigational Site	Akron	Ohio
United States	Pfizer Investigational Site	Akron	Ohio
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Altoona	Pennsylvania
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Anderson	South Carolina
United States	Pfizer Investigational Site	Augusta	Georgia
United States	Pfizer Investigational Site	Aventura	Florida
United States	Pfizer Investigational Site	Avon	Indiana
United States	Pfizer Investigational Site	Bangor	Maine
United States	Pfizer Investigational Site	Bangor	Maine
United States	Pfizer Investigational Site	Bellaire	Texas
United States	Pfizer Investigational Site	Belton	South Carolina
United States	Pfizer Investigational Site	Berkeley	California
United States	Pfizer Investigational Site	Bethesda	Maryland
United States	Pfizer Investigational Site	Beverly Hills	California
United States	Pfizer Investigational Site	Billings	Montana
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Bismarck	North Dakota
United States	Pfizer Investigational Site	Bismark	North Dakota
United States	Pfizer Investigational Site	Bismark	North Dakota
United States	Pfizer Investigational Site	Boca Raton	Florida
United States	Pfizer Investigational Site	Boise	Idaho
United States	Pfizer Investigational Site	Boise	Idaho
United States	Pfizer Investigational Site	Boise	Idaho
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Bozeman	Montana
United States	Pfizer Investigational Site	Bridgeport	Connecticut
United States	Pfizer Investigational Site	Bronx	New York
United States	Pfizer Investigational Site	Brookline	Massachusetts
United States	Pfizer Investigational Site	Brooklyn Center	Minnesota
United States	Pfizer Investigational Site	Cadwell	Idaho
United States	Pfizer Investigational Site	Camp Hill	Pennsylvania
United States	Pfizer Investigational Site	Cape Coral	Florida
United States	Pfizer Investigational Site	Centerville	Ohio
United States	Pfizer Investigational Site	Champaign	Illinois
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Cheyenne	Wyoming
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Clearwater	Florida
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Daytona Beach	Florida
United States	Pfizer Investigational Site	Daytona Beach	Florida
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Delray Beach	Florida
United States	Pfizer Investigational Site	Duncansville	Pennsylvania
United States	Pfizer Investigational Site	Evansville	Indiana
United States	Pfizer Investigational Site	Evansville	Indiana
United States	Pfizer Investigational Site	Evansville	Indiana
United States	Pfizer Investigational Site	Fall River	Massachusetts
United States	Pfizer Investigational Site	Fall River	Massachusetts
United States	Pfizer Investigational Site	Fargo	North Dakota
United States	Pfizer Investigational Site	Fargo	North Dakota
United States	Pfizer Investigational Site	Flowood	Mississippi
United States	Pfizer Investigational Site	Fort Myers	Florida
United States	Pfizer Investigational Site	Fresno	California
United States	Pfizer Investigational Site	Fresno	California
United States	Pfizer Investigational Site	Ft. Myers	Florida
United States	Pfizer Investigational Site	Gainesville	Florida
United States	Pfizer Investigational Site	Glendale	Arizona
United States	Pfizer Investigational Site	Grand Rapids	Michigan
United States	Pfizer Investigational Site	Grand Rapids	Michigan
United States	Pfizer Investigational Site	Hamden	Connecticut
United States	Pfizer Investigational Site	Henderson	Nevada
United States	Pfizer Investigational Site	Holiday	Florida
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Huntsville	Alabama
United States	Pfizer Investigational Site	Idaho Falls	Idaho
United States	Pfizer Investigational Site	Jackson	Mississippi
United States	Pfizer Investigational Site	Jamestown	North Dakota
United States	Pfizer Investigational Site	Jefferson City	Missouri
United States	Pfizer Investigational Site	Johnstown	Pennsylvania
United States	Pfizer Investigational Site	Kalamazaoo	Michigan
United States	Pfizer Investigational Site	Kalamazoo	Michigan
United States	Pfizer Investigational Site	Kansas City	Kansas
United States	Pfizer Investigational Site	Kettering	Ohio
United States	Pfizer Investigational Site	La Jolla	California
United States	Pfizer Investigational Site	Lake Worth	Florida
United States	Pfizer Investigational Site	Lakewood	Colorado
United States	Pfizer Investigational Site	Langhome	Pennsylvania
United States	Pfizer Investigational Site	Largo	Florida
United States	Pfizer Investigational Site	Lemoyne	Pennsylvania
United States	Pfizer Investigational Site	Libertyville	Illinois
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Longmont	Colorado
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Lousiville	Kentucky
United States	Pfizer Investigational Site	Lyndhurst	Ohio
United States	Pfizer Investigational Site	Madison	Connecticut
United States	Pfizer Investigational Site	Manchester Twp	New Jersey
United States	Pfizer Investigational Site	Mayfield Village	Ohio
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Meridian	Idaho
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	Minot	North Dakota
United States	Pfizer Investigational Site	Minot	North Dakota
United States	Pfizer Investigational Site	Missoula	Montana
United States	Pfizer Investigational Site	Missoula	Montana
United States	Pfizer Investigational Site	Missoula	Montana
United States	Pfizer Investigational Site	Mobile	Alabama
United States	Pfizer Investigational Site	Mt. Pleasant	South Carolina
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	New Hyde Park	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Newark	Delaware
United States	Pfizer Investigational Site	Newtown	Pennsylvania
United States	Pfizer Investigational Site	Norfolk	Virginia
United States	Pfizer Investigational Site	North Las Vegas	Nevada
United States	Pfizer Investigational Site	Oakes	North Dakota
United States	Pfizer Investigational Site	Oakland	California
United States	Pfizer Investigational Site	Ocean	New Jersey
United States	Pfizer Investigational Site	Oklahoma	Oklahoma
United States	Pfizer Investigational Site	Oklahoma	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Ormond Beach	Florida
United States	Pfizer Investigational Site	Palm Beach Gardens	Florida
United States	Pfizer Investigational Site	Palm Desert	California
United States	Pfizer Investigational Site	Palm Harbor	Florida
United States	Pfizer Investigational Site	Palm Springs	California
United States	Pfizer Investigational Site	Palm Springs	California
United States	Pfizer Investigational Site	Palm Springs	California
United States	Pfizer Investigational Site	Pembroke Pines	Florida
United States	Pfizer Investigational Site	Pembroke Pines	Florida
United States	Pfizer Investigational Site	Peoria	Illinois
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Plantation	Florida
United States	Pfizer Investigational Site	Port Orange	Florida
United States	Pfizer Investigational Site	Princeton	New Jersey
United States	Pfizer Investigational Site	Rancho Mirage	California
United States	Pfizer Investigational Site	Reno	Nevada
United States	Pfizer Investigational Site	Reno	Nevada
United States	Pfizer Investigational Site	Riverdale	Georgia
United States	Pfizer Investigational Site	Robbinsdale	Minnesota
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Sarasota	Florida
United States	Pfizer Investigational Site	Sarasota	Florida
United States	Pfizer Investigational Site	Scottsdale	Arizona
United States	Pfizer Investigational Site	Scottsdale	Arizona
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Sellersville	Pennsylvania
United States	Pfizer Investigational Site	Shoreview	Minnesota
United States	Pfizer Investigational Site	Silver Spring	Maryland
United States	Pfizer Investigational Site	Sioux Falls	South Dakota
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	St Louis	Missouri
United States	Pfizer Investigational Site	St Petersburg	Florida
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	Temple	Texas
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Upland	California
United States	Pfizer Investigational Site	Virginia Beach	Virginia
United States	Pfizer Investigational Site	Waco	Texas
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Waterbury	Connecticut
United States	Pfizer Investigational Site	Waterdown	South Dakota
United States	Pfizer Investigational Site	Watertown	South Dakota
United States	Pfizer Investigational Site	West Palm Beach	Florida
United States	Pfizer Investigational Site	West Palm Beach	Florida
United States	Pfizer Investigational Site	West Palm Beach	Florida
United States	Pfizer Investigational Site	West Palm Beach	Florida
United States	Pfizer Investigational Site	West Reading	Pennsylvania
United States	Pfizer Investigational Site	Wheat Ridge	Colorado
United States	Pfizer Investigational Site	Wheaton	Maryland
United States	Pfizer Investigational Site	Whittier	California
United States	Pfizer Investigational Site	Winston-Salem	North Carolina
United States	Pfizer Investigational Site	Wyomissing	Pennsylvania
United States	Pfizer Investigational Site	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Croatia,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Italy,  Lithuania,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Incidence of Breast Cancer 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	No
Secondary	Incidence of Breast Cancer 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	No
Secondary	Incidence of Breast Cancer 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	No
Secondary	Percentage of Participants With New Clinical Vertebral Fractures 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	No
Secondary	Percentage of Participants With New Clinical Vertebral Fractures 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	No
Secondary	Percentage of Participants With New Clinical Vertebral Fractures 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	No
Secondary	Number of Participants With Worsening Vertebral Fractures 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	No
Secondary	Number of Participants With Worsening Vertebral Fractures 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	No
Secondary	Number of Participants With Worsening Vertebral Fractures 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	No
Secondary	Percentage of Participants With Non-vertebral Fractures 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	No
Secondary	Percentage of Participants With Non-vertebral Fractures 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	No
Secondary	Percentage of Participants With Non-vertebral Fractures 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	No
Secondary	Change From Baseline in Height at Month 36	Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).	Baseline, Month 36	No
Secondary	Change From Baseline in Height at Month 60	Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).	Baseline, Month 60	No
Secondary	Change From Baseline in Height at Month 84	Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).	Baseline, Month 84	No
Secondary	Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 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	No
Secondary	Percent Change From Baseline in Bone Mineral Density (BMD) at Months 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	No
Secondary	Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 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	No
Secondary	Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12	Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.	Baseline, Months 3, 6, 12	No
Secondary	Percent Change From Baseline in Osteocalcin at Months 36 and 60	Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.	Baseline, Months 36, 60	No
Secondary	Percent Change From Baseline in Osteocalcin at Months 72 and 84	Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.	Baseline, Months 72, 84	No
Secondary	Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12	C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.	Baseline, Months 3, 6, 12	No
Secondary	Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60	C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.	Baseline, Months 36, 60	No
Secondary	Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84	C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.	Baseline, Months 72, 84	No
Secondary	Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 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	No
Secondary	Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP	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	No
Secondary	Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP	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	No
Secondary	Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh	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	No
Secondary	Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh	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	No
Secondary	Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG]	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	No
Secondary	Bone Histomorphometric Indices at Month 60: TSG	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	No
Secondary	Bone Histomorphometric Indices at Month 36: TtAr	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	No
Secondary	Bone Histomorphometric Indices at Month 60: TtAr	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	No
Secondary	Bone Histomorphometric Indices at Month 36: BFP, RP and RmP	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	No
Secondary	Bone Histomorphometric Indices at Month 60: BFP, RP and RmP	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	No
Secondary	Bone Histomorphometric Indices at Month 36: SuD	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	No
Secondary	Bone Histomorphometric Indices at Month 60: SuD	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	No
Secondary	Bone Histomorphometric Indices at Month 36: BFRTS	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	No
Secondary	Bone Histomorphometric Indices at Month 60: BFRTS	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	No
Secondary	Bone Histomorphometric Indices at Month 36: ACF	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	No
Secondary	Bone Histomorphometric Indices at Month 60: ACF	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	No
Secondary	Bone Histomorphometric Indices at Month 36: Mlt	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	No
Secondary	Bone Histomorphometric Indices at Month 60: Mlt	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	No
Secondary	Bone Histomorphometric Indices at Month 36: MAR	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	No
Secondary	Bone Histomorphometric Indices at Month 60: MAR	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	No
Secondary	Bone Histomorphometric Indices at Month 36: TbN	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	No
Secondary	Bone Histomorphometric Indices at Month 60: TbN	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	No
Secondary	Bone Histomorphometric Indices at Month 36: BFRBV	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	No
Secondary	Bone Histomorphometric Indices at Month 60: BFRBV	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	No
Secondary	Women's Health Questionnaire (WHQ)	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	No
Secondary	Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 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	No
Secondary	European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO)	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	No
Secondary	Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 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	No
Secondary	Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)	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	No
Secondary	Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 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	No
Secondary	Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score	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	No
Secondary	Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 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	No

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