Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 7,609
- 试验地点
- 1
- 主要终点
- Percentage of Participants With New Vertebral Fractures Through Month 36
研究概览
简要总结
The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must be at least 2 years postmenopausal
- •Osteoporotic subjects without vertebral fracture who meet BMD criteria, or Osteoporotic subjects with vertebral fracture
排除标准
- •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
研究组 & 干预措施
A
干预措施: Bazedoxifene Acetate (Drug)
B
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Participants With New Vertebral Fractures Through Month 36
时间窗: Baseline 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.
Percentage of Participants With New Vertebral Fractures Through Month 60
时间窗: Baseline 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.
Percentage of Participants With New Vertebral Fractures Through Month 84
时间窗: Baseline 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.
次要结局
- Change From Baseline in Height at Month 36(Baseline, Month 36)
- Change From Baseline in Height at Month 60(Baseline, Month 60)
- Percentage of Participants With Non-vertebral Fractures Through Month 84(Baseline through Month 84)
- Incidence of Breast Cancer Through Month 36(Baseline through Month 36)
- Incidence of Breast Cancer Through Month 60(Baseline through Month 60)
- Incidence of Breast Cancer Through Month 84(Baseline through Month 84)
- Percentage of Participants With New Clinical Vertebral Fractures Through Month 36(Baseline through Month 36)
- Percentage of Participants With New Clinical Vertebral Fractures Through Month 60(Baseline through Month 60)
- Percentage of Participants With New Clinical Vertebral Fractures Through Month 84(Baseline through Month 84)
- Number of Participants With Worsening Vertebral Fractures Through Month 36(Baseline through Month 36)
- Number of Participants With Worsening Vertebral Fractures Through Month 60(Baseline through Month 60)
- Number of Participants With Worsening Vertebral Fractures Through Month 84(Baseline through Month 84)
- Percentage of Participants With Non-vertebral Fractures Through Month 36(Baseline through Month 36)
- Percentage of Participants With Non-vertebral Fractures Through Month 60(Baseline through Month 60)
- Change From Baseline in Height at Month 84(Baseline, Month 84)
- Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36(Baseline, Months 6, 12, 18, 24, 36)
- Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60(Baseline, Month 48, 60)
- Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84(Baseline, Month 72, 84)
- Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12(Baseline, Months 3, 6, 12)
- Percent Change From Baseline in Osteocalcin at Months 36 and 60(Baseline, Months 36, 60)
- Percent Change From Baseline in Osteocalcin at Months 72 and 84(Baseline, Months 72, 84)
- Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12(Baseline, Months 3, 6, 12)
- Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60(Baseline, Months 36, 60)
- Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84(Baseline, Months 72, 84)
- Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36(Baseline, Months 6, 12, 24, 36)
- Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP(Month 36)
- Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP(Month 60)
- Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh(Month 36)
- Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh(Month 60)
- Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG](Month 36)
- Bone Histomorphometric Indices at Month 60: TSG(Month 60)
- Bone Histomorphometric Indices at Month 36: TtAr(Month 36)
- Bone Histomorphometric Indices at Month 60: TtAr(Month 60)
- Bone Histomorphometric Indices at Month 36: BFP, RP and RmP(Month 36)
- Bone Histomorphometric Indices at Month 60: BFP, RP and RmP(Month 60)
- Bone Histomorphometric Indices at Month 36: SuD(Month 36)
- Bone Histomorphometric Indices at Month 60: SuD(Month 60)
- Bone Histomorphometric Indices at Month 36: BFRTS(Month 36)
- Bone Histomorphometric Indices at Month 60: BFRTS(Month 60)
- Bone Histomorphometric Indices at Month 36: ACF(Month 36)
- Bone Histomorphometric Indices at Month 60: ACF(Month 60)
- Bone Histomorphometric Indices at Month 36: Mlt(Month 36)
- Bone Histomorphometric Indices at Month 60: Mlt(Month 60)
- Bone Histomorphometric Indices at Month 36: MAR(Month 36)
- Bone Histomorphometric Indices at Month 60: MAR(Month 60)
- Bone Histomorphometric Indices at Month 36: TbN(Month 36)
- Bone Histomorphometric Indices at Month 60: TbN(Month 60)
- Bone Histomorphometric Indices at Month 36: BFRBV(Month 36)
- Bone Histomorphometric Indices at Month 60: BFRBV(Month 60)
- Women's Health Questionnaire (WHQ)(Baseline)
- Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36(Baseline, Months 12, 24, 36)
- European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO)(Baseline)
- Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36(Baseline, Months 12, 24, 36)
- Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)(Baseline)
- Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36(Baseline, Months 12, 24, 36)
- Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score(Baseline)
- Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36(Baseline, Months 12, 24, 36)