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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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Scientific title
Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women
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Secondary ID [1]
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B1781001
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Secondary ID [2]
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3068A1-301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoporosis
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Condition category
Condition code
Musculoskeletal
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Osteoporosis
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With New Vertebral Fractures Through Month 36
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline through Month 36
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Primary outcome [2]
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Percentage of Participants With New Vertebral Fractures Through Month 60
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline through Month 60
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Primary outcome [3]
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Percentage of Participants With New Vertebral Fractures Through Month 84
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline through Month 84
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Secondary outcome [1]
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Incidence of Breast Cancer Through Month 36
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline through Month 36
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Secondary outcome [2]
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Incidence of Breast Cancer Through Month 60
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Assessment method [2]
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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).
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Timepoint [2]
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Baseline through Month 60
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Secondary outcome [3]
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Incidence of Breast Cancer Through Month 84
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Assessment method [3]
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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).
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Timepoint [3]
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Baseline through Month 84
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Secondary outcome [4]
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Percentage of Participants With New Clinical Vertebral Fractures Through Month 36
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline through Month 36
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Secondary outcome [5]
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Percentage of Participants With New Clinical Vertebral Fractures Through Month 60
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline through Month 60
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Secondary outcome [6]
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Percentage of Participants With New Clinical Vertebral Fractures Through Month 84
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline through Month 84
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Secondary outcome [7]
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Number of Participants With Worsening Vertebral Fractures Through Month 36
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline through Month 36
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Secondary outcome [8]
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Number of Participants With Worsening Vertebral Fractures Through Month 60
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline through Month 60
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Secondary outcome [9]
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Number of Participants With Worsening Vertebral Fractures Through Month 84
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline through Month 84
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Secondary outcome [10]
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Percentage of Participants With Non-vertebral Fractures Through Month 36
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Assessment method [10]
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Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.
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Timepoint [10]
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Baseline through Month 36
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Secondary outcome [11]
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Percentage of Participants With Non-vertebral Fractures Through Month 60
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Assessment method [11]
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Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.
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Timepoint [11]
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Baseline through Month 60
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Secondary outcome [12]
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Percentage of Participants With Non-vertebral Fractures Through Month 84
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Assessment method [12]
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Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.
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Timepoint [12]
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Baseline through Month 84
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Secondary outcome [13]
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Change From Baseline in Height at Month 36
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Assessment method [13]
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Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).
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Timepoint [13]
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Baseline, Month 36
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Secondary outcome [14]
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Change From Baseline in Height at Month 60
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Assessment method [14]
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Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).
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Timepoint [14]
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Baseline, Month 60
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Secondary outcome [15]
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Change From Baseline in Height at Month 84
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Assessment method [15]
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Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).
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Timepoint [15]
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Baseline, Month 84
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Secondary outcome [16]
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Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36
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Assessment method [16]
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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.
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Timepoint [16]
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Baseline, Months 6, 12, 18, 24, 36
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Secondary outcome [17]
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Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60
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Assessment method [17]
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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.
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Timepoint [17]
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Baseline, Month 48, 60
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Secondary outcome [18]
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Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84
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Assessment method [18]
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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.
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Timepoint [18]
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Baseline, Month 72, 84
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Secondary outcome [19]
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Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12
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Assessment method [19]
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Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.
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Timepoint [19]
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Baseline, Months 3, 6, 12
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Secondary outcome [20]
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Percent Change From Baseline in Osteocalcin at Months 36 and 60
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Assessment method [20]
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Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.
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Timepoint [20]
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Baseline, Months 36, 60
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Secondary outcome [21]
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Percent Change From Baseline in Osteocalcin at Months 72 and 84
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Assessment method [21]
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Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.
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Timepoint [21]
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Baseline, Months 72, 84
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Secondary outcome [22]
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Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12
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Assessment method [22]
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C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.
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Timepoint [22]
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Baseline, Months 3, 6, 12
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Secondary outcome [23]
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Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60
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Assessment method [23]
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C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.
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Timepoint [23]
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Baseline, Months 36, 60
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Secondary outcome [24]
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Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84
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Assessment method [24]
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C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.
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Timepoint [24]
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Baseline, Months 72, 84
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Secondary outcome [25]
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Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36
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Assessment method [25]
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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).
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Timepoint [25]
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Baseline, Months 6, 12, 24, 36
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Secondary outcome [26]
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Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP
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Assessment method [26]
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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).
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Timepoint [26]
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Month 36
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Secondary outcome [27]
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Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP
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Assessment method [27]
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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).
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Timepoint [27]
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Month 60
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Secondary outcome [28]
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Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh
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Assessment method [28]
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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.
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Timepoint [28]
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Month 36
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Secondary outcome [29]
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Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh
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Assessment method [29]
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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.
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Timepoint [29]
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Month 60
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Secondary outcome [30]
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Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG]
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Assessment method [30]
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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.
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Timepoint [30]
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Month 36
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Secondary outcome [31]
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Bone Histomorphometric Indices at Month 60: TSG
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Assessment method [31]
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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.
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Timepoint [31]
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Month 60
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Secondary outcome [32]
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Bone Histomorphometric Indices at Month 36: TtAr
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Assessment method [32]
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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.
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Timepoint [32]
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Month 36
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Secondary outcome [33]
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Bone Histomorphometric Indices at Month 60: TtAr
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Assessment method [33]
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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.
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Timepoint [33]
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Month 60
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Secondary outcome [34]
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Bone Histomorphometric Indices at Month 36: BFP, RP and RmP
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Assessment method [34]
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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).
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Timepoint [34]
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Month 36
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Secondary outcome [35]
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Bone Histomorphometric Indices at Month 60: BFP, RP and RmP
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Assessment method [35]
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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).
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Timepoint [35]
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Month 60
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Secondary outcome [36]
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Bone Histomorphometric Indices at Month 36: SuD
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Assessment method [36]
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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).
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Timepoint [36]
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Month 36
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Secondary outcome [37]
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Bone Histomorphometric Indices at Month 60: SuD
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Assessment method [37]
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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).
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Timepoint [37]
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Month 60
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Secondary outcome [38]
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Bone Histomorphometric Indices at Month 36: BFRTS
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Assessment method [38]
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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).
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Timepoint [38]
0
0
Month 36
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Secondary outcome [39]
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Bone Histomorphometric Indices at Month 60: BFRTS
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Assessment method [39]
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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).
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Timepoint [39]
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0
Month 60
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Secondary outcome [40]
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Bone Histomorphometric Indices at Month 36: ACF
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Assessment method [40]
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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).
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Timepoint [40]
0
0
Month 36
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Secondary outcome [41]
0
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Bone Histomorphometric Indices at Month 60: ACF
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Assessment method [41]
0
0
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).
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Timepoint [41]
0
0
Month 60
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Secondary outcome [42]
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Bone Histomorphometric Indices at Month 36: Mlt
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Assessment method [42]
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0
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.
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Timepoint [42]
0
0
Month 36
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Secondary outcome [43]
0
0
Bone Histomorphometric Indices at Month 60: Mlt
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Assessment method [43]
0
0
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.
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Timepoint [43]
0
0
Month 60
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Secondary outcome [44]
0
0
Bone Histomorphometric Indices at Month 36: MAR
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Assessment method [44]
0
0
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.
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Timepoint [44]
0
0
Month 36
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Secondary outcome [45]
0
0
Bone Histomorphometric Indices at Month 60: MAR
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Assessment method [45]
0
0
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.
Query!
Timepoint [45]
0
0
Month 60
Query!
Secondary outcome [46]
0
0
Bone Histomorphometric Indices at Month 36: TbN
Query!
Assessment method [46]
0
0
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.
Query!
Timepoint [46]
0
0
Month 36
Query!
Secondary outcome [47]
0
0
Bone Histomorphometric Indices at Month 60: TbN
Query!
Assessment method [47]
0
0
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.
Query!
Timepoint [47]
0
0
Month 60
Query!
Secondary outcome [48]
0
0
Bone Histomorphometric Indices at Month 36: BFRBV
Query!
Assessment method [48]
0
0
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).
Query!
Timepoint [48]
0
0
Month 36
Query!
Secondary outcome [49]
0
0
Bone Histomorphometric Indices at Month 60: BFRBV
Query!
Assessment method [49]
0
0
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).
Query!
Timepoint [49]
0
0
Month 60
Query!
Secondary outcome [50]
0
0
Women's Health Questionnaire (WHQ)
Query!
Assessment method [50]
0
0
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.
Query!
Timepoint [50]
0
0
Baseline
Query!
Secondary outcome [51]
0
0
Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36
Query!
Assessment method [51]
0
0
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.
Query!
Timepoint [51]
0
0
Baseline, Months 12, 24, 36
Query!
Secondary outcome [52]
0
0
European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO)
Query!
Assessment method [52]
0
0
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.
Query!
Timepoint [52]
0
0
Baseline
Query!
Secondary outcome [53]
0
0
Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36
Query!
Assessment method [53]
0
0
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.
Query!
Timepoint [53]
0
0
Baseline, Months 12, 24, 36
Query!
Secondary outcome [54]
0
0
Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
Query!
Assessment method [54]
0
0
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.
Query!
Timepoint [54]
0
0
Baseline
Query!
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
Query!
Assessment method [55]
0
0
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.
Query!
Timepoint [55]
0
0
Baseline, Months 12, 24, 36
Query!
Secondary outcome [56]
0
0
Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score
Query!
Assessment method [56]
0
0
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.
Query!
Timepoint [56]
0
0
Baseline
Query!
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
Query!
Assessment method [57]
0
0
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.
Query!
Timepoint [57]
0
0
Baseline, Months 12, 24, 36
Query!
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
Query!
Minimum age
55
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/12/2001
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/09/2010
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
7609
Query!
Recruitment in Australia
Recruitment state(s)
NSW,WA
Query!
Recruitment hospital [1]
0
0
Pfizer Investigational Site - Concord
Query!
Recruitment hospital [2]
0
0
Pfizer Investigational Site - St Leonards
Query!
Recruitment hospital [3]
0
0
Pfizer Investigational Site - Nedlands
Query!
Recruitment hospital [4]
0
0
Pfizer Investigational Site - Herston
Query!
Recruitment hospital [5]
0
0
Pfizer Investigational Site - Keswick
Query!
Recruitment postcode(s) [1]
0
0
2139 - Concord
Query!
Recruitment postcode(s) [2]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [3]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [4]
0
0
QLD 4029 - Herston
Query!
Recruitment postcode(s) [5]
0
0
- Keswick
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Delaware
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
District of Columbia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Florida
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Georgia
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Idaho
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Illinois
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Indiana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Kansas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Kentucky
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Maine
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Maryland
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Massachusetts
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Michigan
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Minnesota
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Mississippi
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Missouri
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Montana
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Nebraska
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Nevada
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
New Jersey
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
New Mexico
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
New York
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
North Carolina
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
North Dakota
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Ohio
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Oklahoma
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Pennsylvania
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
South Carolina
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
South Dakota
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Tennessee
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Texas
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Utah
Query!
Country [38]
0
0
United States of America
Query!
State/province [38]
0
0
Virginia
Query!
Country [39]
0
0
United States of America
Query!
State/province [39]
0
0
Washington
Query!
Country [40]
0
0
United States of America
Query!
State/province [40]
0
0
Wisconsin
Query!
Country [41]
0
0
United States of America
Query!
State/province [41]
0
0
Wyoming
Query!
Country [42]
0
0
Argentina
Query!
State/province [42]
0
0
Provincia de Buenos Aires
Query!
Country [43]
0
0
Austria
Query!
State/province [43]
0
0
Graz
Query!
Country [44]
0
0
Belgium
Query!
State/province [44]
0
0
Diepenbeek
Query!
Country [45]
0
0
Belgium
Query!
State/province [45]
0
0
Genk
Query!
Country [46]
0
0
Belgium
Query!
State/province [46]
0
0
Gent
Query!
Country [47]
0
0
Belgium
Query!
State/province [47]
0
0
Leuven
Query!
Country [48]
0
0
Belgium
Query!
State/province [48]
0
0
Liege
Query!
Country [49]
0
0
Belgium
Query!
State/province [49]
0
0
Schiepsebos
Query!
Country [50]
0
0
Brazil
Query!
State/province [50]
0
0
GO
Query!
Country [51]
0
0
Brazil
Query!
State/province [51]
0
0
MT
Query!
Country [52]
0
0
Brazil
Query!
State/province [52]
0
0
RJ
Query!
Country [53]
0
0
Brazil
Query!
State/province [53]
0
0
Sao Paulo
Query!
Country [54]
0
0
Brazil
Query!
State/province [54]
0
0
SP
Query!
Country [55]
0
0
Bulgaria
Query!
State/province [55]
0
0
Pleven
Query!
Country [56]
0
0
Bulgaria
Query!
State/province [56]
0
0
Plovdiv
Query!
Country [57]
0
0
Bulgaria
Query!
State/province [57]
0
0
Sofia
Query!
Country [58]
0
0
Canada
Query!
State/province [58]
0
0
Alberta
Query!
Country [59]
0
0
Canada
Query!
State/province [59]
0
0
British Columbia
Query!
Country [60]
0
0
Canada
Query!
State/province [60]
0
0
Manitoba
Query!
Country [61]
0
0
Canada
Query!
State/province [61]
0
0
Ontario
Query!
Country [62]
0
0
Canada
Query!
State/province [62]
0
0
Quebec
Query!
Country [63]
0
0
Canada
Query!
State/province [63]
0
0
Saskatchewan
Query!
Country [64]
0
0
Chile
Query!
State/province [64]
0
0
Santiago
Query!
Country [65]
0
0
Croatia
Query!
State/province [65]
0
0
Zadar
Query!
Country [66]
0
0
Croatia
Query!
State/province [66]
0
0
Zagreb
Query!
Country [67]
0
0
Denmark
Query!
State/province [67]
0
0
Aalborg
Query!
Country [68]
0
0
Denmark
Query!
State/province [68]
0
0
Ballerup
Query!
Country [69]
0
0
Denmark
Query!
State/province [69]
0
0
Vejle
Query!
Country [70]
0
0
Estonia
Query!
State/province [70]
0
0
Tallinn
Query!
Country [71]
0
0
Estonia
Query!
State/province [71]
0
0
Tartu
Query!
Country [72]
0
0
Finland
Query!
State/province [72]
0
0
FIN
Query!
Country [73]
0
0
Finland
Query!
State/province [73]
0
0
Jyvaskyla
Query!
Country [74]
0
0
Finland
Query!
State/province [74]
0
0
Jyväskylä
Query!
Country [75]
0
0
Finland
Query!
State/province [75]
0
0
Kuopio
Query!
Country [76]
0
0
Finland
Query!
State/province [76]
0
0
Lahti
Query!
Country [77]
0
0
Finland
Query!
State/province [77]
0
0
Oulu
Query!
Country [78]
0
0
Finland
Query!
State/province [78]
0
0
Turku
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Lyon Cedex 03
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Orleans cedex 1
Query!
Country [81]
0
0
France
Query!
State/province [81]
0
0
Paris
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Berlin
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Muenchen
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Zerbst
Query!
Country [85]
0
0
Greece
Query!
State/province [85]
0
0
Athens
Query!
Country [86]
0
0
Hong Kong
Query!
State/province [86]
0
0
Hong Kong
Query!
Country [87]
0
0
Hong Kong
Query!
State/province [87]
0
0
PRC
Query!
Country [88]
0
0
Hong Kong
Query!
State/province [88]
0
0
Sai Ying Pung
Query!
Country [89]
0
0
Hungary
Query!
State/province [89]
0
0
Bekescsaba
Query!
Country [90]
0
0
Hungary
Query!
State/province [90]
0
0
H-6720 Szeged
Query!
Country [91]
0
0
Hungary
Query!
State/province [91]
0
0
Kecskemet
Query!
Country [92]
0
0
Hungary
Query!
State/province [92]
0
0
Mako
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
Roma
Query!
Country [94]
0
0
Italy
Query!
State/province [94]
0
0
Siena
Query!
Country [95]
0
0
Lithuania
Query!
State/province [95]
0
0
Kaunas
Query!
Country [96]
0
0
Lithuania
Query!
State/province [96]
0
0
Vilnius
Query!
Country [97]
0
0
Mexico
Query!
State/province [97]
0
0
Estado de Mexico
Query!
Country [98]
0
0
Mexico
Query!
State/province [98]
0
0
Mexico City
Query!
Country [99]
0
0
Mexico
Query!
State/province [99]
0
0
Mexico D.F.
Query!
Country [100]
0
0
Netherlands
Query!
State/province [100]
0
0
Dr
Query!
Country [101]
0
0
Netherlands
Query!
State/province [101]
0
0
GA
Query!
Country [102]
0
0
Netherlands
Query!
State/province [102]
0
0
HV
Query!
Country [103]
0
0
Netherlands
Query!
State/province [103]
0
0
SZ
Query!
Country [104]
0
0
Netherlands
Query!
State/province [104]
0
0
Eindhoven
Query!
Country [105]
0
0
Netherlands
Query!
State/province [105]
0
0
Rotterdam
Query!
Country [106]
0
0
New Zealand
Query!
State/province [106]
0
0
Auckland
Query!
Country [107]
0
0
New Zealand
Query!
State/province [107]
0
0
NZ
Query!
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Dunedin
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Hamar
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Oslo
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Trondheim
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Poland
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Lublin
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Warszawa
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Wroclaw
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Napoca
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Bucharesti
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Bucharest
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Bucuresti
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Romania
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Cluj-Napoca
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Iasi
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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St Petersburg
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Russian Federation
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St. Petersburg
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Bratislava
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South Africa
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Pretoria
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Bedford Gardens
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South Africa
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Johannesburg 2193
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South Africa
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Johannesburg, 2193
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Johannesburg
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Parow 7500
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Parow
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Pretoria, 0042
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Pretoria, 0181
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Somerset West, 7129
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South Africa
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Somerset West, 7130
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Somerset West
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South Africa
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Stellenbosch 7600
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Spain
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Madrid
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Funding & Sponsors
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Commercial sector/Industry
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Name
Pfizer
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00205777
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Contacts
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Pfizer CT.gov Call Center
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Pfizer
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00205777
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