NCT05010590进行中（未招募）4 期
Anabolic Therapy in Postmenopausal Osteoporosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Total hip areal bone mineral density
研究概览
简要总结
In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of 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
- •Postmenopausal women at high risk of fracture
排除标准
- •Prior therapy exclusions
- •current use or use in the past 12 months of oral bisphosphonates or denosumab
- •current use or use within the past 3 months of estrogens, SERMs, or calcitonin.
- •use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
- •any current or previous use of romosozumab or strontium
- •current use or use within the past 3 years of teriparatide, abaloparatide, or any parenteral bisphosphonate.
- •Other exclusions
- •Confirmed serum alkaline greater than 2 times the upper normal limit.
- •Stage 4 or 5 chronic kidney disease (GFR less than 30)
- •Hypercalcemia (Ca greater than 10.5 mg/dL)
- •Hypocalcemia (Ca less than 8.8 mg/dL)
- •Elevated blood PTH (intact PTH greater than 77 pg/mL)
- •Serum 25-OH vitamin D less than 20 ng/mL
- •HCT less than 32%.
- •History of malignancy (except basal cell carcinoma).
- •Significant pulmonary disease
- •History of myocardial infarction or stroke within the preceding year.
- •History of unstable angina or transient ischemic attack in the past year.
- •Current atrial fibrillation.
- •Any health condition that, in the opinion of the study physician, significantly increases the risk of cardiovascular events.
- •Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- •Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- •Uncontrolled eczema
- •Congenital or acquired bone disease other than osteoporosis.
- •Known sensitivity to denosumab or any of its excipients.
- •Known sensitivity to romosozumab or any of its excipients.
- •History of osteonecrosis of the jaw, extensive dental work involving extraction or dental implants in the past 3 months, or extensive dental work planned in the upcoming 12 months.
研究组 & 干预措施
Romosozumab and denosumab
Active Comparator
干预措施: Denosumab (Drug)
Romosozumab
Active Comparator
干预措施: Romosozumab (Drug)
Romosozumab and denosumab
Active Comparator
干预措施: Romosozumab (Drug)
结局指标
主要结局
Total hip areal bone mineral density
时间窗: Month 0 to 12
Change in total hip 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
Principal Investigator
Massachusetts General Hospital
研究点 (1)
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