NCT06558188招募中4 期
Combined Anabolic Therapy Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Lumbar spine areal bone mineral density
研究概览
简要总结
In this research study the study investigators want to learn more about the effect of two different FDA-approved medication regimens in the treatment of 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women aged 45+
- •postmenopausal
- •osteoporotic with high risk of fracture
排除标准
- •no significant previous use of bone health modifying treatments
- •known congenital or acquired bone disease other than osteoporosis
- •significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
- •abnormal calcium or parathyroid hormone level
- •serum vitamin D <20 ng/dL
- •anemia (hematocrit <32%)
- •history of malignancy (except non-melanoma skin carcinoma)
- •excessive alcohol use or substance abuse
- •known contraindications to romosozumab or teriparatide
研究组 & 干预措施
Romosozumab and Teriparatide
Active Comparator
romosozumab and teriparatide
干预措施: Teriparatide (Drug)
Romosozumab
Active Comparator
romosozumab
干预措施: Romosozumab (Drug)
Romosozumab and Teriparatide
Active Comparator
romosozumab and teriparatide
干预措施: Romosozumab (Drug)
结局指标
主要结局
Lumbar spine areal bone mineral density
时间窗: Month 0 to 12
Change in lumbar spine bone density between month 0 and month 12
次要结局
未报告次要终点
研究者
Benjamin Leder, MD
Professor of Medicine
Massachusetts General Hospital
研究点 (1)
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