A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 7,180
- 试验地点
- 1
- 主要终点
- Percentage of Participants With New Vertebral Fracture Through Month 12
研究概览
简要总结
The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score at the total hip or femoral neck of ≤ -2.50)
排除标准
- •BMD T-score of ≤ -3.50 at the total hip or femoral neck
- •History of hip fracture
- •Any severe or more than 2 moderate vertebral fractures, as assessed by the central imaging based on lateral spine x-rays
- •Use of agents affecting bone metabolism
- •History of metabolic or bone disease (except osteoporosis)
- •Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
- •Current hyper- or hypocalcemia
- •Current, uncontrolled hyper- or hypothyroidism
- •Current, uncontrolled hyper- or hypoparathyroidism
研究组 & 干预措施
Romosozumab
Participants received 210 mg romosozumab subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
干预措施: Romosozumab (Drug)
Romosozumab
Participants received 210 mg romosozumab subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
干预措施: Denosumab (Drug)
Placebo
Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
干预措施: Placebo (Drug)
Placebo
Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
干预措施: Denosumab (Drug)
结局指标
主要结局
Percentage of Participants With New Vertebral Fracture Through Month 12
时间窗: 12 Months
New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method. The Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale: * Grade 0 (Normal) = no fracture; * Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); * Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; * Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.
Percentage of Participants With New Vertebral Fracture Through Month 24
时间窗: 24 months
New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method. The Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale: * Grade 0 (Normal) = no fracture; * Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); * Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; * Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.
次要结局
- Percentage of Participants With a Nonvertebral Fracture Through Month 12(12 Months)
- Percentage of Participants With a Clinical Fracture Through Month 12(12 Months)
- Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 12(12 Months)
- Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24(24 Months)
- Percentage of Participants With a Major Osteoporotic Fracture Through Month 12(12 Months)
- Percentage of Participants With a Nonvertebral Fracture Through Month 24(24 Months)
- Percentage of Participants With a Clinical Fracture Through Month 24(24 Months)
- Percentage of Participants With a Major Nonvertebral Fracture Through Month 12(12 Months)
- Percentage of Participants With a Hip Fracture Through Month 12(12 Months)
- Percentage of Participants With a Hip Fracture Through Month 24(24 Months)
- Percentage of Participants With a Major Nonvertebral Fracture Through Month 24(24 Months)
- Percentage of Participants With a Major Osteoporotic Fracture Through Month 24(24 Months)
- Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 12(12 Months)
- Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24(24 Months)
- Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12(Baseline and Month 12)
- Percent Change From Baseline In Bone Mineral Density at the Lumbar Spine at Month 24(Baseline and Month 24)
- Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 12(Baseline and Month 12)
- Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24(Baseline and Month 24)
- Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 12(Baseline and Month 12)
- Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 24(Baseline and Month 24)