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

  Show 376 Study Locations
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:
Bazedoxifene
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 27, 2014