NCT01343004已完成3 期
A Randomized, Double-blind, Placebo-Controlled, Comparative Multicenter Phase 3 Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women With Severe Osteoporosis and at Risk of Fracture
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,463
- 主要终点
- Number of Participants With New Vertebral Fractures at 18 Months
研究概览
简要总结
The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.
详细描述
This is a randomized, double-blind, placebo-controlled, comparative Phase 3, multicenter international study to evaluate the efficacy and safety of BA058 (abaloparatide) 80 µg in the prevention of fracture in otherwise healthy ambulatory postmenopausal women with severe 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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy ambulatory postmenopausal (≥ 5 years) women from 50 to 85 years of age (inclusive) with a diagnosis of osteoporosis
- •The women are to have a bone mineral density (BMD) T score ≤ -2.5 and > -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T score ≤ -2.0 and > -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T score is ≤ -3.0 and > -5.0
- •Normal physical exam, vital signs, electrocardiogram (ECG) and medical history
- •Laboratory tests within the normal range including serum calcium, PTH(1-84), serum phosphorus and alkaline phosphatase
排除标准
- •History of more than 4 mild or moderate spine fractures or any severe fracture
- •Abnormality of the spine or hip that would prohibit assessment of bone mineral density (BMD)
- •Unexplained elevation of serum alkaline phosphatase, history of bone disorders (such as Paget's disease) or a diagnosis of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)
- •History of thyroid, parathyroid, or adrenal disorders, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient
- •Prior treatment with parathyroid hormone (PTH) or parathyroid hormone-related peptid (PTHrP)
- •Prior treatment with bisphosphonates, fluoride, or strontium within the past five years or treatment with androgens, anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months (except hormone replacement therapy)
- •Prior treatment with an investigational drug within the past 12 months
- •History of nephrolithiasis or urolithiasis within the past five years, or history of osteosarcoma at any time
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo identical in appearance to BA058 study drug
干预措施: Placebo (Drug)
BA058 80 mcg (abaloparatide)
Experimental
干预措施: BA058 80 mcg (Drug)
teriparatide
Active Comparator
Blinded until after randomization, then open-label
干预措施: teriparatide (Drug)
结局指标
主要结局
Number of Participants With New Vertebral Fractures at 18 Months
时间窗: 18 months
次要结局
- Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18(Baseline and 18 months)
- Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months(18 months)
- Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18(Baseline and 18 months)
- Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months(Basline and 18 months)
- Number of Participants With Non-vertebral Fractures at 18 Months(18 months)
研究者
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