Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs
研究概览
简要总结
The etiology of bone marrow edema (BME) is still uncertain. Several studies report therapeutic success with antiresorptive drugs.
This study investigates antiresorptive and osteoanabolic drugs versus placebo in BME
详细描述
Patients are assigned to receive either denosumab 60mg sc (once) or placebo or daily teriparatide sc for three months or placebo.
MRI examinations at baseline and after three months will be performed. Serum bone turnover markers will be evaluated as well as QoL questionnaires.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MRI diagnosed bone marrow edema
排除标准
- •any prior antiresorptive or osteoanabolic treatment
- •any prior therapy with strontium ranelate
- •Hyper-/hypocalcemia
- •malignancies
- •pregnancy
- •and contraindication against denosumab or teriparatide
研究组 & 干预措施
Teriparatide
daily subcutaneous injection of teriparatide 20µg for three months
干预措施: Teriparatide (Drug)
Placebo Teriparatide
daily subcutaneous teriparatide placebo injection
干预措施: Placebo Teriparatide (Drug)
Denosumab
one subcutaneous injection of denosumab
干预措施: Denosumab (Drug)
Placebo Denosumab
one subcutaneous injection of denosumab placebo
干预措施: Placebo Denosumab (Drug)
结局指标
主要结局
Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs
时间窗: baseline - month 1 - month 3
MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score
次要结局
未报告次要终点
研究者
Dr. Christian Muschitz
Principal Investigator
Medical University of Vienna