NCT01588509已完成1 期
An Open-label, Randomized Study to Estimate the Percent Change From Baseline in Lumbar Spine Bone Mineral Density After 3 Months of AMG 785 Administration in Postmenopausal Women With Low Bone Mineral Density Previously Treated With Alendronate
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine
研究概览
简要总结
The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated with alendronate.
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
- None
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women, defined as no vaginal bleeding or spotting for ≥ 12 months
- •Low bone mineral density at screening [defined by a bone mineral density (BMD) T-score ≤ -2.0 and ≥ -4.0 at the lumbar spine (L1 to L4; or BMD T-score of evaluable vertebrae), total hip, or femoral neck]
- •Currently taking alendronate (70 mg weekly or equivalent) exclusively for ≥ 1 year with verbal agreement that the subject has taken ≥ 80% of their doses with good tolerance
排除标准
- •History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis after age 50; or recent bone fracture within 6 months prior to screening
- •History of metabolic or bone disease such as Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
- •Vitamin D deficiency (defined as 25-OH-VitD levels < 20 ng/mL)
研究组 & 干预措施
Romosozumab 140 mg
Experimental
Participants received romosozumab 140 mg administered subcutaneously once a month for 3 months.
干预措施: Romosozumab (Drug)
Romosozumab 210 mg
Experimental
Participants received romosozumab 210 mg administered subcutaneously once a month for 3 months.
干预措施: Romosozumab (Drug)
结局指标
主要结局
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine
时间窗: Baseline and day 85
Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and analyzed by a central imaging lab.
次要结局
- Percent Change From Baseline in Serum Type-1 Aminoterminal Propeptide (P1NP)(Baseline and days 4, 15, 29, 43, 57, 71, and 85)
- Percent Change From Baseline in Bone Mineral Density (BMD) at the Femoral Neck(Baseline and day 85)
- Number of Participants With Adverse Events(From first dose of study drug up to day 85)
- Mean Serum Concentration of Romosozumab(Days 4, 15, 29, 43, 57, 71 and 85)
- Percent Change From Baseline in Bone Mineral Density (BMD) at the Total Hip(Baseline and day 85)
- Percent Change From Baseline in Serum C-telopeptide (sCTX)(Baseline and days 4, 15, 29, 43, 57, 71, and 85)
- Number of Participants Who Developed Anti-romosozumab Antibodies(Baseline and days 29, 57, and 85)
研究者
研究点 (1)
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