Denosumab vs Zoledronate in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Femoral neck BMD
研究概览
简要总结
Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP). Denosumab and zoledronate acid is both effective to prevent bone loss for OVCF postmenopausal women. However, trial evidence comparing effect of denosumab vs zoledronate after PVP was unknown. The study aims to assess the efficiency of denosumab vs zoledronate for OVCF patients bone mineral density (BMD), bone turnover markers (BTMs), secondary fracture and adverse events after PVP.
详细描述
Whether denosumab was non-inferior than zoledronate in improving bone mineral density (BMD), bone turnover markers (BTMs), functional status questionnaires, and secondary fracture in elderly patients with OVCF after PVP remains unknown. A prospective, randomized, placebo-controlled clinical trial in OVCF patients with PVP was performed. This study aimed to investigate the efficiency of denosumab vs zoledronate on BMD, BTMs, functional status, secondary fracture rate, and adverse events in OVCF patients after PVP during a 12-month follow-up period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants were randomized using a block randomization model (block size 5). Computer-generated, random-number sequences were prepared by an experienced statistician. Consecutive treatment allocations were stored in sealed opaque envelopes and assigned to doctors. Patients and doctors were blinded to the assignments; all researchers and data analysts were blinded as to the allocation during the 12-month follow-up period.
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be age between 50 and 90 years old
- •X-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5
- •Bone mineral density T value less than -1 via dual-energy X-ray
- •A recent fracture history less than 6 weeks
- •MRI show bone marrow edema of fractured vertebrae
- •low back pain, local paravertebral tenderness
排除标准
- •Must be able to have no 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
- •Must be able to have no inability to perform magnetic resonance imaging
- •Must be able to have no prior back open surgery
- •Must be able to have no other established contraindications for elective surgery
研究组 & 干预措施
Denosumab
1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months
干预措施: Denosumab Injection (Drug)
zoledronate
Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months.
干预措施: Zoledronate (Drug)
结局指标
主要结局
Femoral neck BMD
时间窗: up to 12 months
Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray
Lumbar bone mineral density(BMD)
时间窗: up to 12 months
Lumbar vertebral (L1 to L4, except the surgery segment) BMD were determined at baseline, 6 and 12 months via dual- energy X-ray
C-terminal cross-linked type 1 collagen terminal peptide (CTX)
时间窗: up to 12 months
Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery
Visual analog scale (VAS) back
时间窗: up to 12 months
The VAS score for back pain were determined at baseline, 6 and 12 month. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.
Total hip BMD
时间窗: up to 12 months
Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray.
Procollagen type 1 n-terminal propeptide (P1NP)
时间窗: up to 12 months
Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery.
次要结局
- The QUALEFFO-31 Questionnaire(up to 12 month)
- The EQ-5D Questionnaire(up to 12 month)
- The Roland-Morris Disability Questionnaire(up to 12 month)
- Secondary fracture rate(up to 12 month)
- Adverse events(up to 12 month)