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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00205777




Registration number
NCT00205777
Ethics application status
Date submitted
16/09/2005
Date registered
20/09/2005
Date last updated
10/04/2013

Titles & IDs
Public title
Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
Scientific title
Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women
Secondary ID [1] 0 0
B1781001
Secondary ID [2] 0 0
3068A1-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bazedoxifene Acetate
Other interventions - Placebo

Active Comparator: A -

Placebo Comparator: B -


Treatment: Drugs: Bazedoxifene Acetate
BZA 20mg, daily, oral

Other interventions: Placebo
Placebo, daily, oral

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With New Vertebral Fractures Through Month 36 - New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.
Timepoint [1] 0 0
Baseline through Month 36
Primary outcome [2] 0 0
Percentage of Participants With New Vertebral Fractures Through Month 60 - New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.
Timepoint [2] 0 0
Baseline through Month 60
Primary outcome [3] 0 0
Percentage of Participants With New Vertebral Fractures Through Month 84 - New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.
Timepoint [3] 0 0
Baseline through Month 84
Secondary outcome [1] 0 0
Incidence of Breast Cancer Through Month 36 - Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).
Timepoint [1] 0 0
Baseline through Month 36
Secondary outcome [2] 0 0
Incidence of Breast Cancer Through Month 60 - Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).
Timepoint [2] 0 0
Baseline through Month 60
Secondary outcome [3] 0 0
Incidence of Breast Cancer Through Month 84 - Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).
Timepoint [3] 0 0
Baseline through Month 84
Secondary outcome [4] 0 0
Percentage of Participants With New Clinical Vertebral Fractures Through Month 36 - A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.
Timepoint [4] 0 0
Baseline through Month 36
Secondary outcome [5] 0 0
Percentage of Participants With New Clinical Vertebral Fractures Through Month 60 - A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.
Timepoint [5] 0 0
Baseline through Month 60
Secondary outcome [6] 0 0
Percentage of Participants With New Clinical Vertebral Fractures Through Month 84 - A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.
Timepoint [6] 0 0
Baseline through Month 84
Secondary outcome [7] 0 0
Number of Participants With Worsening Vertebral Fractures Through Month 36 - A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.
Timepoint [7] 0 0
Baseline through Month 36
Secondary outcome [8] 0 0
Number of Participants With Worsening Vertebral Fractures Through Month 60 - A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.
Timepoint [8] 0 0
Baseline through Month 60
Secondary outcome [9] 0 0
Number of Participants With Worsening Vertebral Fractures Through Month 84 - A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.
Timepoint [9] 0 0
Baseline through Month 84
Secondary outcome [10] 0 0
Percentage of Participants With Non-vertebral Fractures Through Month 36 - Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.
Timepoint [10] 0 0
Baseline through Month 36
Secondary outcome [11] 0 0
Percentage of Participants With Non-vertebral Fractures Through Month 60 - Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.
Timepoint [11] 0 0
Baseline through Month 60
Secondary outcome [12] 0 0
Percentage of Participants With Non-vertebral Fractures Through Month 84 - Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.
Timepoint [12] 0 0
Baseline through Month 84
Secondary outcome [13] 0 0
Change From Baseline in Height at Month 36 - Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).
Timepoint [13] 0 0
Baseline, Month 36
Secondary outcome [14] 0 0
Change From Baseline in Height at Month 60 - Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).
Timepoint [14] 0 0
Baseline, Month 60
Secondary outcome [15] 0 0
Change From Baseline in Height at Month 84 - Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).
Timepoint [15] 0 0
Baseline, Month 84
Secondary outcome [16] 0 0
Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 - BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.
Timepoint [16] 0 0
Baseline, Months 6, 12, 18, 24, 36
Secondary outcome [17] 0 0
Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 - BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.
Timepoint [17] 0 0
Baseline, Month 48, 60
Secondary outcome [18] 0 0
Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 - BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.
Timepoint [18] 0 0
Baseline, Month 72, 84
Secondary outcome [19] 0 0
Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 - Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.
Timepoint [19] 0 0
Baseline, Months 3, 6, 12
Secondary outcome [20] 0 0
Percent Change From Baseline in Osteocalcin at Months 36 and 60 - Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.
Timepoint [20] 0 0
Baseline, Months 36, 60
Secondary outcome [21] 0 0
Percent Change From Baseline in Osteocalcin at Months 72 and 84 - Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.
Timepoint [21] 0 0
Baseline, Months 72, 84
Secondary outcome [22] 0 0
Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 - C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.
Timepoint [22] 0 0
Baseline, Months 3, 6, 12
Secondary outcome [23] 0 0
Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60 - C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.
Timepoint [23] 0 0
Baseline, Months 36, 60
Secondary outcome [24] 0 0
Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84 - C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.
Timepoint [24] 0 0
Baseline, Months 72, 84
Secondary outcome [25] 0 0
Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 - Lipid parameters evaluated included total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), triglyceride (TG), high-density lipoprotein fraction 2 (HDL2) and high-density lipoprotein fraction 3 (HDL3).
Timepoint [25] 0 0
Baseline, Months 6, 12, 24, 36
Secondary outcome [26] 0 0
Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).
Timepoint [26] 0 0
Month 36
Secondary outcome [27] 0 0
Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).
Timepoint [27] 0 0
Month 60
Secondary outcome [28] 0 0
Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Wall Thickness (WTh), Osteoid Thickness (OTh), Trabecular Thickness (TbTh), Trabecular Separation (TbSp) and Cortical thickness (CTh). Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.
Timepoint [28] 0 0
Month 36
Secondary outcome [29] 0 0
Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: WTh, OTh, TbTh, TbSp and CTh. Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.
Timepoint [29] 0 0
Month 60
Secondary outcome [30] 0 0
Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG] - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner`s staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.
Timepoint [30] 0 0
Month 36
Secondary outcome [31] 0 0
Bone Histomorphometric Indices at Month 60: TSG - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner`s staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.
Timepoint [31] 0 0
Month 60
Secondary outcome [32] 0 0
Bone Histomorphometric Indices at Month 36: TtAr - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made.
Timepoint [32] 0 0
Month 36
Secondary outcome [33] 0 0
Bone Histomorphometric Indices at Month 60: TtAr - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made.
Timepoint [33] 0 0
Month 60
Secondary outcome [34] 0 0
Bone Histomorphometric Indices at Month 36: BFP, RP and RmP - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP).
Timepoint [34] 0 0
Month 36
Secondary outcome [35] 0 0
Bone Histomorphometric Indices at Month 60: BFP, RP and RmP - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP).
Timepoint [35] 0 0
Month 60
Secondary outcome [36] 0 0
Bone Histomorphometric Indices at Month 36: SuD - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD).
Timepoint [36] 0 0
Month 36
Secondary outcome [37] 0 0
Bone Histomorphometric Indices at Month 60: SuD - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD).
Timepoint [37] 0 0
Month 60
Secondary outcome [38] 0 0
Bone Histomorphometric Indices at Month 36: BFRTS - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).
Timepoint [38] 0 0
Month 36
Secondary outcome [39] 0 0
Bone Histomorphometric Indices at Month 60: BFRTS - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).
Timepoint [39] 0 0
Month 60
Secondary outcome [40] 0 0
Bone Histomorphometric Indices at Month 36: ACF - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).
Timepoint [40] 0 0
Month 36
Secondary outcome [41] 0 0
Bone Histomorphometric Indices at Month 60: ACF - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).
Timepoint [41] 0 0
Month 60
Secondary outcome [42] 0 0
Bone Histomorphometric Indices at Month 36: Mlt - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.
Timepoint [42] 0 0
Month 36
Secondary outcome [43] 0 0
Bone Histomorphometric Indices at Month 60: Mlt - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.
Timepoint [43] 0 0
Month 60
Secondary outcome [44] 0 0
Bone Histomorphometric Indices at Month 36: MAR - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval.
Timepoint [44] 0 0
Month 36
Secondary outcome [45] 0 0
Bone Histomorphometric Indices at Month 60: MAR - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval.
Timepoint [45] 0 0
Month 60
Secondary outcome [46] 0 0
Bone Histomorphometric Indices at Month 36: TbN - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.
Timepoint [46] 0 0
Month 36
Secondary outcome [47] 0 0
Bone Histomorphometric Indices at Month 60: TbN - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.
Timepoint [47] 0 0
Month 60
Secondary outcome [48] 0 0
Bone Histomorphometric Indices at Month 36: BFRBV - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).
Timepoint [48] 0 0
Month 36
Secondary outcome [49] 0 0
Bone Histomorphometric Indices at Month 60: BFRBV - Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).
Timepoint [49] 0 0
Month 60
Secondary outcome [50] 0 0
Women's Health Questionnaire (WHQ) - WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Timepoint [50] 0 0
Baseline
Secondary outcome [51] 0 0
Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 - WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction.Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Timepoint [51] 0 0
Baseline, Months 12, 24, 36
Secondary outcome [52] 0 0
European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) - QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Timepoint [52] 0 0
Baseline
Secondary outcome [53] 0 0
Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 - QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Timepoint [53] 0 0
Baseline, Months 12, 24, 36
Secondary outcome [54] 0 0
Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) - EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Timepoint [54] 0 0
Baseline
Secondary outcome [55] 0 0
Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 - EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Timepoint [55] 0 0
Baseline, Months 12, 24, 36
Secondary outcome [56] 0 0
Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score - EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Timepoint [56] 0 0
Baseline
Secondary outcome [57] 0 0
Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 - EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Timepoint [57] 0 0
Baseline, Months 12, 24, 36

Eligibility
Key inclusion criteria
- Must be at least 2 years postmenopausal

- Osteoporotic subjects without vertebral fracture who meet BMD criteria, or
Osteoporotic subjects with vertebral fracture
Minimum age
55 Years
Maximum age
80 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diseases that may affect bone metabolism

- Vasomotor symptoms requiring treatment

- Known history or suspected cancer of the breast

- Active or past history of venous thromboembolic events

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Concord
Recruitment hospital [2] 0 0
Pfizer Investigational Site - St Leonards
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Nedlands
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Keswick
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment postcode(s) [4] 0 0
QLD 4029 - Herston
Recruitment postcode(s) [5] 0 0
- Keswick
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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GO
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FIN
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PRC
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Bekescsaba
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H-6720 Szeged
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Kecskemet
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Mako
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Roma
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Siena
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Lithuania
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Kaunas
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Lithuania
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Mexico
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Dr
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GA
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HV
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SZ
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Eindhoven
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NZ
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Dunedin
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Bergen
Country [110] 0 0
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Hamar
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Oslo
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Trondheim
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Katowice
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Bucuresti
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Romania
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Cluj-Napoca
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State/province [130] 0 0
Pretoria
Country [131] 0 0
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Bedford Gardens
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Johannesburg 2193
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South Africa
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Johannesburg, 2193
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South Africa
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Johannesburg
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South Africa
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Parow 7500
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South Africa
State/province [136] 0 0
Parow
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South Africa
State/province [137] 0 0
Pretoria, 0042
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State/province [138] 0 0
Pretoria, 0181
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South Africa
State/province [139] 0 0
Somerset West, 7129
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South Africa
State/province [140] 0 0
Somerset West, 7130
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South Africa
State/province [141] 0 0
Somerset West
Country [142] 0 0
South Africa
State/province [142] 0 0
Stellenbosch 7600
Country [143] 0 0
Spain
State/province [143] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether bazedoxifene acetate is safe and effective
in the treatment of osteoporosis in postmenopausal women.
Trial website
https://clinicaltrials.gov/show/NCT00205777
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications