2024-515610-41-00招募中2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Safety, Tolerability and Efficacy of AGA2118 in Postmenopausal Women with Low Bone Mineral Density
Angitia Inc. Ltd.9 个研究点 分布在 4 个国家目标入组 260 人开始时间: 2025年1月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 9
- 主要终点
- Percent change from Baseline to Month 12 in lumbar spine BMD
研究概览
简要总结
To determine the effect of treatment with AGA2118 versus placebo at Month 12 on the percent change from Baseline in BMD at the lumbar spine in postmenopausal women with low BMD
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Open-label period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy, ambulatory, postmenopausal women age >=55 to <=80
- •BMD T-score of <=-2.5 to >-3.5 at the lumbar spine, total hip, or femoral neck
排除标准
- •History of vertebral fracture, or fragility fracture of the wrist, humerus, proximal femur, or pelvis
- •Current hypo- or hypercalcemia
- •Positive for HIV, hepatitis C virus, or hepatitis B surface antigen
- •Diagnosis of a familial cancer syndrome or known genetic mutation that increases risk of cancer
- •Myocardial infarction or stroke within the past 12 months
- •Malignancy within the last 5 years
- •Use of agents affecting bone metabolism
- •Vitamin D deficiency
- •Known intolerance to calcium or vitamin D supplements
- •Untreated hyper- or hypothyroidism
- •Current hyper- or hypoparathyroidism
- •Elevated transaminases
- •Significantly impaired renal function
结局指标
主要结局
Percent change from Baseline to Month 12 in lumbar spine BMD
Percent change from Baseline to Month 12 in lumbar spine BMD
次要结局
- Percent change from Baseline to Months 3 and 6 in lumbar spine, total hip, femoral neck, and one-third distal radius BMD
- Percent change from Baseline to Month 12 in total hip, femoral neck, and one-third distal radius BMD
- Percent change from Baseline to Months 1, 3, 6, 9, and 12 in [CCI]
- Incidence of new clinical fractures (vertebral and nonvertebral) between Baseline and Month 12
研究者
Ricardo Dent, MD
Scientific
Angitia Inc. Ltd.
研究点 (9)
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