NCT06154187尚未招募3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bone mineral density (BMD) change rate
研究概览
简要总结
This clinical trial was multicenter, randomized, double-blind, placebo-controlled, parallel, phase III bridge study.
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
- •Be a healthy ambulatory postmenopausal woman from 50 to 85 years of age (inclusive) with osteoporosis.
- •Be postmenopausal for at least 5 years. Postmenopausal status was established by a history of amenorrhea for at least 5 years and by an elevated serum follicle-stimulating hormone (FSH) value of ≥30 IU/L.
- •Be 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 femoral, radius, humerus, sacral, pelvic, or ankle 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
排除标准
- •History of more than 4 spine fractures, mild or moderate, or any severe fractures.
- •Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal bone mineral density, defined as having at least 2 radiologically evaluable vertebrae within L1-L
- •Unevaluable hip Bone mineral density (BMD) or patients who had undergone bilateral hip replacement (unilateral hip replacement was acceptable).
研究组 & 干预措施
test 1
Experimental
PBK_L2201
干预措施: PBK_L2201 (Drug)
placebo
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Bone mineral density (BMD) change rate
时间窗: 12 month
The % change from baseline in lumbar spine Bone mineral density (BMD) through end of 12-month treatment.
次要结局
- Bone mineral density (BMD) change(6, 12 and 18 month)
- Bone mineral density (BMD) % change(6, 12 and 18 month)
- % incidence of new non-vertebral fractures(12 month)
研究者
研究点 (1)
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