jRCT1051210070招募中不适用
Prospective observational study of the effect of romosozumab in postmenopausal osteoporotic women with inadequate response to existing osteoporosis treatment (Prospective observational study of the effect of romosozumab in postmenopausal osteoporotic women with inadequate response to existing osteoporosis treatment)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 主要终点
- Change in bone mineral density of the lumbar spine
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- Female
入选标准
- •Patients with postmenopausal osteoporosis who have been treated with bisphosphonates or denosumab at our department for at least one year, but whose bone mineral density values of lumbar spine or femur by DXA method are less than 70% of YAM (Young Adult Mean) will be included.
- •Bone mineral density will be measured by measuring the bone mineral density of the lumbar spine and femur by the double X-ray absorptiometry (DXA method) using a bone mineral density measurement device (Discovery A Hologic) installed at our hospital. The diagnosis shall be based on the therapeutic intervention criteria set forth by the Japanese Society of Osteoporosis and shall meet the following diagnostic criteria.
- •The criteria for the diagnosis of osteoporosis are as follows:
- •For patients with fragility fractures, 1:there must be a vertebral fracture or a proximal femoral fracture 2: There must be other fragility fractures and the bone density must be less than 80% of the YAM.
- •In the absence of a fragility fracture, bone density should be less than 70% of the YAM or less than -2.5 SD.
- •The cause of osteoporosis is not limited to postmenopausal osteoporosis, but also includes osteoporosis associated with hormone decline after cancer treatment.
排除标准
- •(1) Patients with a history of hypersensitivity to components of sclerostin products.
- •(2) Patients with hypocalcemia.
- •(3) Patients who are judged by the physician in charge to be inappropriate for this study for other reasons.
结局指标
主要结局
Change in bone mineral density of the lumbar spine
时间窗: 6 or 12 months
To evaluate the efficacy of the study drug based on the **amount (and rate) of change** in bone mineral density of the lumbar spine after 6 or 12 months of treatment relative to the starting value of the study drug. Bone densitometry will be performed using the **DXA (dual X-ray absorptiometry)** method.
Change in bone mineral density of the femur
时间窗: 6 or 12 months
To evaluate the efficacy of the study drug based on the **amount (and rate) of change** in bone mineral density of the femur after 6 or 12 months of treatment relative to the starting value of the study drug. Bone densitometry will be performed using the **DXA (dual X-ray absorptiometry)** method.
次要结局
- correlation with bone mineral density assessment
- bone metabolism markers (P1NP and sCTX)(6 or 12 months)
研究者
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