Attending Doctor of Shenzhen People's Hospital
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- albumin
研究概览
简要总结
Evaluation of bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures with desuzumab: a parallel double-blind randomized controlled clinical trial
详细描述
Conduct a single-center, double-blind, randomized controlled clinical trial according to clinical Trial Reporting Standards (CONSORT). Bone mineral density and function were compared 1 year after screw internal fixation of osteoporotic vertebral compression fracture (OVCF) with desomumab versus placebo in Shenzhen People's Hospital from September, 2021 to September, 2022. The study was approved by Shenzhen People's Hospital and informed consent was signed
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be age between 40 and 90 years old
- •X-ray diagnosis of 1-2 vertebral compression fractures
- •Dual energy X ray test bone mineral density T value less than -1
- •fracture history lasted within 6 weeks
- •MRI showed bone marrow edema of injured segment
- •lower back pain, local spines tenderness
排除标准
- •• Must be able to have no posterior vertebral wall fracture
- •Must be able to have no patients with intervertebral fissure
- •Must be able to have no infection
- •Must be able to have no malignancy
- •Must be able to have no neurological dysfunction
- •Must be able to have no previous use of anti-osteoporosis drugs within 6 weeks
- •Must be able to have no inability to perform magnetic resonance imaging
- •Must be able to have no prior back surgery
- •Must be able to have no other established contraindications for elective surgery
研究组 & 干预措施
dnosumab
Desuzumab 60 mg subcutaneously /6 months, twice a year
干预措施: Denosumab Only Product (Drug)
placebo control
Placebo subcutaneous injection /6 months, twice a year
干预措施: Denosumab Only Product (Drug)
结局指标
主要结局
albumin
时间窗: up to 12 months
serum albumin level
parathyroid hormone
时间窗: up to 12 months
serum parathyroid hormone level
Serum total calcium
时间窗: up to 12 months
Serum total calcium level
height
时间窗: up to 12 months
participants height cm
weight
时间窗: up to 12 months
participants weight kg
BMI
时间窗: up to 12 months
participants body mass index
osteocalcin
时间窗: up to 12 months
osteocalcin in the N terminal molecular fragment
Procollagen type 1 n-terminal propeptide P1NP
时间窗: up to 12 months
Procollagen type 1 n-terminal propeptide
C-terminal cross-linked type 1 collagen terminal peptide CTX
时间窗: up to 12 months
C-terminal cross-linked type 1 collagen terminal peptide
sex
时间窗: up to 12 months
participants sex
age
时间窗: up to 12 months
participants age (year)
lumber spine bone mineral density
时间窗: up to 12 months
Dual energy X-ray for lumber spine bone mineral density
Hip bone mineral density
时间窗: up to 12 months
Dual energy X-ray for hip bone mineral density
MRI of lumber
时间窗: up to 12 months
Bone marrow edema and adjacent intervertebral disc were detected by MRI
pain visual analogue scores (VAS)
时间窗: up to 12 months
pain visual analogue scores (VAS) use categories to differentiate pain intensity, with 0 being "painless" and 100 being "the worst pain imaginable".
次要结局
- The Roland-Morris Disability Questionnaire(up to 12 month)
- QUALEFFO 31(up to 12 month)
- EuroQol-5D (EQ-5D): an instrument for measuring quality of life(up to 12 month)