Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00205777
First received: September 16, 2005
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Osteoporosis
Drug: Bazedoxifene Acetate
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With New Vertebral Fractures Through Month 36 [ Time Frame: Baseline through Month 36 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With New Vertebral Fractures Through Month 60 [ Time Frame: Baseline through Month 60 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With New Vertebral Fractures Through Month 84 [ Time Frame: Baseline through Month 84 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Incidence of Breast Cancer Through Month 36 [ Time Frame: Baseline through Month 36 ] [ Designated as safety issue: No ]
    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).

  • Incidence of Breast Cancer Through Month 60 [ Time Frame: Baseline through Month 60 ] [ Designated as safety issue: No ]
    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).

  • Incidence of Breast Cancer Through Month 84 [ Time Frame: Baseline through Month 84 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With New Clinical Vertebral Fractures Through Month 36 [ Time Frame: Baseline through Month 36 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With New Clinical Vertebral Fractures Through Month 60 [ Time Frame: Baseline through Month 60 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With New Clinical Vertebral Fractures Through Month 84 [ Time Frame: Baseline through Month 84 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Worsening Vertebral Fractures Through Month 36 [ Time Frame: Baseline through Month 36 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Worsening Vertebral Fractures Through Month 60 [ Time Frame: Baseline through Month 60 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Worsening Vertebral Fractures Through Month 84 [ Time Frame: Baseline through Month 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Non-vertebral Fractures Through Month 36 [ Time Frame: Baseline through Month 36 ] [ Designated as safety issue: No ]
    Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.

  • Percentage of Participants With Non-vertebral Fractures Through Month 60 [ Time Frame: Baseline through Month 60 ] [ Designated as safety issue: No ]
    Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.

  • Percentage of Participants With Non-vertebral Fractures Through Month 84 [ Time Frame: Baseline through Month 84 ] [ Designated as safety issue: No ]
    Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.

  • Change From Baseline in Height at Month 36 [ Time Frame: Baseline, Month 36 ] [ Designated as safety issue: No ]
    Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).

  • Change From Baseline in Height at Month 60 [ Time Frame: Baseline, Month 60 ] [ Designated as safety issue: No ]
    Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).

  • Change From Baseline in Height at Month 84 [ Time Frame: Baseline, Month 84 ] [ Designated as safety issue: No ]
    Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 [ Time Frame: Baseline, Month 48, 60 ] [ Designated as safety issue: No ]
    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.

  • Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 [ Time Frame: Baseline, Month 72, 84 ] [ Designated as safety issue: No ]
    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.

  • Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 [ Time Frame: Baseline, Months 3, 6, 12 ] [ Designated as safety issue: No ]
    Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.

  • Percent Change From Baseline in Osteocalcin at Months 36 and 60 [ Time Frame: Baseline, Months 36, 60 ] [ Designated as safety issue: No ]
    Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.

  • Percent Change From Baseline in Osteocalcin at Months 72 and 84 [ Time Frame: Baseline, Months 72, 84 ] [ Designated as safety issue: No ]
    Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.

  • Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 [ Time Frame: Baseline, Months 3, 6, 12 ] [ Designated as safety issue: No ]
    C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.

  • Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60 [ Time Frame: Baseline, Months 36, 60 ] [ Designated as safety issue: No ]
    C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.

  • Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84 [ Time Frame: Baseline, Months 72, 84 ] [ Designated as safety issue: No ]
    C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.

  • Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 [ Time Frame: Baseline, Months 6, 12, 24, 36 ] [ Designated as safety issue: No ]
    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).

  • Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    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).

  • Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
    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).

  • Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    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.

  • Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
    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.

  • Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG] [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    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.

  • Bone Histomorphometric Indices at Month 60: TSG [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
    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.

  • Bone Histomorphometric Indices at Month 36: TtAr [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    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.

  • Bone Histomorphometric Indices at Month 60: TtAr [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
    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.

  • Bone Histomorphometric Indices at Month 36: BFP, RP and RmP [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    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).

  • Bone Histomorphometric Indices at Month 60: BFP, RP and RmP [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
    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).

  • Bone Histomorphometric Indices at Month 36: SuD [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    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).

  • Bone Histomorphometric Indices at Month 60: SuD [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
    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).

  • Bone Histomorphometric Indices at Month 36: BFRTS [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    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).

  • Bone Histomorphometric Indices at Month 60: BFRTS [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
    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).

  • Bone Histomorphometric Indices at Month 36: ACF [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    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).

  • Bone Histomorphometric Indices at Month 60: ACF [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
    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).

  • Bone Histomorphometric Indices at Month 36: Mlt [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    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.

  • Bone Histomorphometric Indices at Month 60: Mlt [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
    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.

  • Bone Histomorphometric Indices at Month 36: MAR [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    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.

  • Bone Histomorphometric Indices at Month 60: MAR [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
    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.

  • Bone Histomorphometric Indices at Month 36: TbN [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    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.

  • Bone Histomorphometric Indices at Month 60: TbN [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
    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.

  • Bone Histomorphometric Indices at Month 36: BFRBV [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    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).

  • Bone Histomorphometric Indices at Month 60: BFRBV [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
    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).

  • Women's Health Questionnaire (WHQ) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 [ Time Frame: Baseline, Months 12, 24, 36 ] [ Designated as safety issue: No ]
    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.

  • European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 7609
Study Start Date: December 2001
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Bazedoxifene Acetate
BZA 20mg, daily, oral
Placebo Comparator: B Other: Placebo
Placebo, daily, oral

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205777

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294-3708
Pfizer Investigational Site
Birmingham, Alabama, United States, 35249-7201
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
United States, Arizona
Pfizer Investigational Site
Glendale, Arizona, United States, 85306
Pfizer Investigational Site
Phoenix, Arizona, United States, 85015
Pfizer Investigational Site
Phoenix, Arizona, United States, 85007
Pfizer Investigational Site
Phoenix, Arizona, United States, 85027
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
Pfizer Investigational Site
Phoenix, Arizona, United States, 85020
Pfizer Investigational Site
Phoenix, Arizona, United States, 85050
Pfizer Investigational Site
Phoenix, Arizona, United States, 85016
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013-3903
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85254
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85251
United States, California
Pfizer Investigational Site
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, 93710
Pfizer Investigational Site
Fresno, California, United States, 93720
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, 92263
Pfizer Investigational Site
Palm Springs, California, United States, 92262
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, 95816
Pfizer Investigational Site
Sacramento, California, United States, 95825
Pfizer Investigational Site
San Diego, California, United States, 92120
Pfizer Investigational Site
San Diego, California, United States, 92108
Pfizer Investigational Site
Upland, California, United States, 91786
Pfizer Investigational Site
Whittier, California, United States, 90602
United States, Colorado
Pfizer Investigational Site
Lakewood, Colorado, United States, 80227
Pfizer Investigational Site
Longmont, Colorado, United States, 80501
Pfizer Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Pfizer Investigational Site
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
United States, Delaware
Pfizer Investigational Site
Newark, Delaware, United States, 19713
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20037
Pfizer Investigational Site
Washington, District of Columbia, United States, 20007
Pfizer Investigational Site
Washington, District of Columbia, United States, 20007-2197
Pfizer Investigational Site
Washington, District of Columbia, United States, 20006
United States, Florida
Pfizer Investigational Site
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, 32117
Pfizer Investigational Site
Daytona Beach, Florida, United States, 32114
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, 33029
Pfizer Investigational Site
Pembroke Pines, Florida, United States, 33027
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, 33417
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
United States, Georgia
Pfizer Investigational Site
Augusta, Georgia, United States, 30909
Pfizer Investigational Site
Decatur, Georgia, United States, 30033
Pfizer Investigational Site
Riverdale, Georgia, United States, 30274
United States, Idaho
Pfizer Investigational Site
Boise, Idaho, United States, 83712
Pfizer Investigational Site
Boise, Idaho, United States, 83704
Pfizer Investigational Site
Boise, Idaho, United States, 83702
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
United States, Illinois
Pfizer Investigational Site
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
United States, Indiana
Pfizer Investigational Site
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
United States, Kansas
Pfizer Investigational Site
Kansas City, Kansas, United States, 66160-7136
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40291
Pfizer Investigational Site
Louisville, Kentucky, United States, 40207
Pfizer Investigational Site
Lousiville, Kentucky, United States, 40291
United States, Maine
Pfizer Investigational Site
Bangor, Maine, United States, 4401
Pfizer Investigational Site
Bangor, Maine, United States, 04401
United States, Maryland
Pfizer Investigational Site
Bethesda, Maryland, United States, 20817
Pfizer Investigational Site
Silver Spring, Maryland, United States, 20902
Pfizer Investigational Site
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Pfizer Investigational Site
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
United States, Michigan
Pfizer Investigational Site
Grand Rapids, Michigan, United States, 49503
Pfizer Investigational Site
Grand Rapids, Michigan, United States, 49546
Pfizer Investigational Site
Kalamazaoo, Michigan, United States, 49048
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49048
United States, Minnesota
Pfizer Investigational Site
Brooklyn Center, Minnesota, United States, 55430
Pfizer Investigational Site
Robbinsdale, Minnesota, United States, 55422
Pfizer Investigational Site
Shoreview, Minnesota, United States, 55126
United States, Mississippi
Pfizer Investigational Site
Flowood, Mississippi, United States, 39232
Pfizer Investigational Site
Jackson, Mississippi, United States, 39216
United States, Missouri
Pfizer Investigational Site
Jefferson City, Missouri, United States, 65109
Pfizer Investigational Site
St Louis, Missouri, United States, 63141
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, Montana
Pfizer Investigational Site
Billings, Montana, United States, 59101
Pfizer Investigational Site
Bozeman, Montana, United States, 59715
Pfizer Investigational Site
Missoula, Montana, United States, 59804
Pfizer Investigational Site
Missoula, Montana, United States, 59801
Pfizer Investigational Site
Missoula, Montana, United States, 59802
United States, Nebraska
Pfizer Investigational Site
Lincoln, Nebraska, United States, 68510
United States, Nevada
Pfizer Investigational Site
Henderson, Nevada, United States, 89014
Pfizer Investigational Site
North Las Vegas, Nevada, United States, 89030
Pfizer Investigational Site
Reno, Nevada, United States, 89502-1196
Pfizer Investigational Site
Reno, Nevada, United States, 89503
United States, New Jersey
Pfizer Investigational Site
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
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87109
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87102
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87106
United States, New York
Pfizer Investigational Site
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
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28277
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28209
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28207
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Pfizer Investigational Site
Bismarck, North Dakota, United States, 58501
Pfizer Investigational Site
Bismark, North Dakota, United States, 58503
Pfizer Investigational Site
Bismark, North Dakota, United States, 58501
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
United States, Ohio
Pfizer Investigational Site
Akron, Ohio, United States, 44313
Pfizer Investigational Site
Akron, Ohio, United States, 44312-1647
Pfizer Investigational Site
Centerville, Ohio, United States, 45459
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45236
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45249
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
United States, Oklahoma
Pfizer Investigational Site
Oklahoma, Oklahoma, United States, 73102
Pfizer Investigational Site
Oklahoma, Oklahoma, United States, 73120
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73142
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73112-4481
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74135
Pfizer Investigational Site
Yukon, Oklahoma, United States, 73099
United States, Pennsylvania
Pfizer Investigational Site
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
United States, South Carolina
Pfizer Investigational Site
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
United States, South Dakota
Pfizer Investigational Site
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
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38120
Pfizer Investigational Site
Memphis, Tennessee, United States, 38104
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
Pfizer Investigational Site
Memphis, Tennessee, United States, 38138
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site
Bellaire, Texas, United States, 77401
Pfizer Investigational Site
Dallas, Texas, United States, 75243
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
Dallas, Texas, United States, 75231
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, 78229-3894
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
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
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84102-3015
United States, Virginia
Pfizer Investigational Site
Norfolk, Virginia, United States, 23502
Pfizer Investigational Site
Virginia Beach, Virginia, United States, 23454
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98133
Pfizer Investigational Site
Seattle, Washington, United States, 98195
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
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53209
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53226
United States, Wyoming
Pfizer Investigational Site
Cheyenne, Wyoming, United States, 82001
Argentina
Pfizer Investigational Site
Provincia de Buenos Aires, Argentina
Australia, New South Wales
Pfizer Investigational Site
Concord, New South Wales, Australia, 2139
Pfizer Investigational Site
St Leonards, New South Wales, Australia, 2065
Australia, Western Australia
Pfizer Investigational Site
Nedlands, Western Australia, Australia, 6009
Australia
Pfizer Investigational Site
Herston, Australia, QLD 4029
Pfizer Investigational Site
Keswick, Australia
Austria
Pfizer Investigational Site
Graz, Austria, 8036
Belgium
Pfizer Investigational Site
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
Brazil
Pfizer Investigational Site
Goiania, GO, Brazil, 74175-080
Pfizer Investigational Site
Duque de Caxias - Cuiaba, MT, Brazil, 78043-306
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 20020-020
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 22271-100
Pfizer Investigational Site
Sorocaba, Sao Paulo, Brazil, 18095-450
Pfizer Investigational Site
São Paulo, SP, Brazil, 04020-060
Bulgaria
Pfizer Investigational Site
Pleven, Bulgaria, 5800
Pfizer Investigational Site
Plovdiv, Bulgaria, 4002
Pfizer Investigational Site
Sofia, Bulgaria, 1504
Pfizer Investigational Site
Sofia, Bulgaria, 1301
Pfizer Investigational Site
Sofia, Bulgaria, 1431
Pfizer Investigational Site
Sofia, Bulgaria, 1407
Pfizer Investigational Site
Sofia, Bulgaria, 1303
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V5Z 2N6
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V6H 3X8
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3A 1M3
Canada, Ontario
Pfizer Investigational Site
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, M5G 1E2
Pfizer Investigational Site
Toronto, Ontario, Canada, M5C 1R6
Pfizer Investigational Site
Toronto, Ontario, Canada, M5C 2T2
Pfizer Investigational Site
Toronto, Ontario, Canada, MB5 1W8
Canada, Quebec
Pfizer Investigational Site
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
Canada, Saskatchewan
Pfizer Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 1N4
Pfizer Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 0H6
Canada
Pfizer Investigational Site
Quebec, Canada, G1V 3M7
Pfizer Investigational Site
Quebec, Canada, G1S 2L6
Chile
Pfizer Investigational Site
Santiago, Chile
Croatia
Pfizer Investigational Site
Zadar, Croatia, 23000
Pfizer Investigational Site
Zagreb, Croatia, 10000
Denmark
Pfizer Investigational Site
Aalborg, Denmark, 9000
Pfizer Investigational Site
Ballerup, Denmark, 2750
Pfizer Investigational Site
Vejle, Denmark, 7100
Estonia
Pfizer Investigational Site
Tallinn, Estonia, 10128
Pfizer Investigational Site
Tartu, Estonia, 51010
Pfizer Investigational Site
Tartu, Estonia, 50410
Pfizer Investigational Site
Tartu, Estonia
Finland
Pfizer Investigational Site
Jyvaskyla, FIN, Finland, 40100
Pfizer Investigational Site
Jyvaskyla, Finland, FIN-40100
Pfizer Investigational Site
Jyväskylä, Finland, 40700
Pfizer Investigational Site
Kuopio, Finland, FIN-70211
Pfizer Investigational Site
Kuopio, Finland, 70210
Pfizer Investigational Site
Kuopio, Finland, 70211
Pfizer Investigational Site
Lahti, Finland
Pfizer Investigational Site
Oulu, Finland, 90 100
Pfizer Investigational Site
Turku, Finland, 20100
France
Pfizer Investigational Site
Lyon Cedex 03, France, 69437
Pfizer Investigational Site
Orleans cedex 1, France, 45032
Pfizer Investigational Site
Paris, France, 75015
Germany
Pfizer Investigational Site
Berlin, Germany, 12200
Pfizer Investigational Site
Muenchen, Germany, 80809
Pfizer Investigational Site
Zerbst, Germany, 39261
Greece
Pfizer Investigational Site
Athens, Greece, 11526
Hong Kong
Pfizer Investigational Site
Hong Kong, Hong Kong
Pfizer Investigational Site
PRC, Hong Kong
Pfizer Investigational Site
Sai Ying Pung, Hong Kong
Hungary
Pfizer Investigational Site
Bekescsaba, Hungary, 5600
Pfizer Investigational Site
H-6720 Szeged, Hungary
Pfizer Investigational Site
Kecskemet, Hungary, 6000
Pfizer Investigational Site
Mako, Hungary, 6900
Italy
Pfizer Investigational Site
Roma, Italy, 00168
Pfizer Investigational Site
Roma, Italy, 00189
Pfizer Investigational Site
Roma, Italy, 00136
Pfizer Investigational Site
Siena, Italy, 53100
Lithuania
Pfizer Investigational Site
Kaunas, Lithuania, LT-50009
Pfizer Investigational Site
Vilnius, Lithuania, LT-04130
Pfizer Investigational Site
Vilnius, Lithuania, LT-10318
Mexico
Pfizer Investigational Site
seccion de Lomas Verdes, Estado de Mexico, Mexico, CP 53120
Pfizer Investigational Site
Mexico City, Mexico, 03100
Pfizer Investigational Site
Mexico D.F., Mexico, 11800
Netherlands
Pfizer Investigational Site
Emmen, Dr, Netherlands, 7824 AA
Pfizer Investigational Site
Nijmegen, GA, Netherlands, 6525
Pfizer Investigational Site
Amsterdam, HV, Netherlands, 1081
Pfizer Investigational Site
Nijmegen, SZ, Netherlands, 6532
Pfizer Investigational Site
Eindhoven, Netherlands, 5611 NJ
Pfizer Investigational Site
Rotterdam, Netherlands, 3001 HG
New Zealand
Pfizer Investigational Site
Milford, Auckland, New Zealand
Pfizer Investigational Site
Christchurch, NZ, New Zealand, 8143
Pfizer Investigational Site
Auckland, New Zealand
Pfizer Investigational Site
Dunedin, New Zealand
Norway
Pfizer Investigational Site
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, NO-7006
Pfizer Investigational Site
Trondheim, Norway, 7006
Poland
Pfizer Investigational Site
Katowice, Poland, 40-084
Pfizer Investigational Site
Krakow, Poland, 30-510
Pfizer Investigational Site
Krakow, Poland, 30-017
Pfizer Investigational Site
Krakow, Poland, 30-224
Pfizer Investigational Site
Krakow, Poland, 31-501
Pfizer Investigational Site
Krakow, Poland, 30-007
Pfizer Investigational Site
Lublin, Poland, 20-090
Pfizer Investigational Site
Warszawa, Poland, 00-655
Pfizer Investigational Site
Warszawa, Poland, 00-315
Pfizer Investigational Site
Warszawa, Poland, 02-341
Pfizer Investigational Site
Warszawa, Poland, 00-418
Pfizer Investigational Site
Warszawa, Poland, 00-909
Pfizer Investigational Site
Warszawa, Poland, 02-796
Pfizer Investigational Site
Warszawa, Poland, 00-699
Pfizer Investigational Site
Warszawa, Poland, 04-730
Pfizer Investigational Site
Warszawa, Poland, 03-335
Pfizer Investigational Site
Wroclaw, Poland, 50-088
Romania
Pfizer Investigational Site
Cluj-, Napoca, Romania, 400000
Pfizer Investigational Site
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
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 119002
Pfizer Investigational Site
Moscow, Russian Federation, 121356
Pfizer Investigational Site
Moscow, Russian Federation, 107014
Pfizer Investigational Site
Moscow, Russian Federation, 117036
Pfizer Investigational Site
Moscow, Russian Federation, 127299
Pfizer Investigational Site
Moscow, Russian Federation, 129010
Pfizer Investigational Site
Moscow, Russian Federation, 101990
Pfizer Investigational Site
Moscow, Russian Federation, 115522
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
Slovakia
Pfizer Investigational Site
Piestany, Slovak Republic, Slovakia
Pfizer Investigational Site
Bratislava, Slovakia, 851 07
Pfizer Investigational Site
Bratislava, Slovakia, 826 06
Pfizer Investigational Site
Bratislava, Slovakia, 83301
Pfizer Investigational Site
Bratislava, Slovakia, 833 01
South Africa
Pfizer Investigational Site
Groenkloof, 0181, Pretoria, South Africa
Pfizer Investigational Site
Bedford Gardens, South Africa
Pfizer Investigational Site
Johannesburg, South Africa, 2196
Pfizer Investigational Site
Johannesburg, South Africa, 2193
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
Spain
Pfizer Investigational Site
Madrid, Spain, 28046
Pfizer Investigational Site
Madrid, Spain, 28040
Pfizer Investigational Site
Madrid, Spain, 28006
Pfizer Investigational Site
Madrid, Spain, 28009
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00205777     History of Changes
Other Study ID Numbers: 3068A1-301, B1781001
Study First Received: September 16, 2005
Results First Received: December 31, 2012
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Osteoporosis
Postmenopause

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Bazedoxifene
Bone Density Conservation Agents
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on October 21, 2014