Attending Physician of Shenzhen People's Hospital
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- age
研究概览
简要总结
Bone mineral density and function at 1 year after screw fixation with denosumab vs zoledronic acid for osteoporotic vertebral compression fractures: 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 of osteoporotic vertebral compression fracture (OVCF) were compared 1 year after screw internal fixation with denosumab vs zoledronic acid in Shenzhen People's Hospital from September, 2021 to November, 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 eneragy X ray test for bone mineral density T value less than -1
- •fracture history lasted within 6 weeks
- •Must be MRI showed bone marrow edema of injured segment
- •Must be 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 calcium level ≤2.13 mmol/L
- •Must be able to have no previous use of anti-osteoporosis drugs
- •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
denosumab
Denosumab 60mg/6 months subcutaneously + placebo intravenous
干预措施: Denosumab (Drug)
zoledronic acid
intravenous zoledronic acid and placebo /6 months subcutaneously
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
age
时间窗: up to 12 months
participants age
sex
时间窗: up to 12 months
participants sex
serum Procollagen type 1 n-terminal propeptide P1NP
时间窗: up to 12 months
Procollagen type 1 n-terminal propeptide
serum osteocalcin
时间窗: up to 12 months
osteocalcin in the N terminal molecular fragment
height
时间窗: up to 12 months
participants height cm
BMI
时间窗: up to 12 months
participants body mass index
serum 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
Serum total calcium
时间窗: up to 12 months
Serum total calcium level
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
DEXA for hip bone mineral density
MRI for 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. There is a wide variability of terms used to describe each category and the rating may be divided into four (0 -3) or six (0 -5) categories. Patients score their pain intensity from absent (0) to severe (3) or from none (0) to very severe (5)
次要结局
- The Roland-Morris Disability Questionnaire(up to 12 month)
- QUALEFFO-31(up to 12 month)
- EuroQol-5D (EQ-5D)(up to 12 month)