The Efficacy Study of Aclasta (Zoledronic Acid 5mg) on Prosthetic Fixation in Postmenopausal Women After Cementless Total Hip Arthroplasty (THA): a 24 Months, Single Center, Open- Label, Randomized, Parallel Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- the transverse translation (μm)
研究概览
简要总结
It's to investigate the efficacy of Zoledronic acid treatment on the early prosthetic fixation in post-menopausal osteoporosis women under cementless total hip arthroplasty after 24-month observation.
详细描述
To investigate the efficacy of Zoledronic acid and placebo treatment on the prosthetic transverse translation in post-menopausal osteoporosis women under cementless total hip arthroplasty by Radiostereometry （RSA）in two-year follow-up period .
Meanwhile to assess efficacy of Zoledronic acid treatment on the vertical translation of acetabulum and the subsidence translation of femoral stem by Radiostereometry（RSA), prevention of peri- prosthetic bone loss by observing the local average bone mineral density ( BMD ) changes for 7 femoral region Gruen zones through Dual Energy X-ray Absorptiometry (DXA）scans, et al.
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
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who was diagnosed with Post-menopausal osteoporosis( bone mineral density T<-2.5;or with previous fragility fracture, bone mineral density T -2.5~-1.5), responding to Zoledronic acid, within one week after the successful cementless total hip arthroplasty surgery.
排除标准
- •Patients with any history of disorders except osteoporosis known to severely affect bone and mineral metabolism such as Paget disease;
- •Patients who suffer from secondary osteoporosis
- •Patients who were treated with bisphosphonate within the previous one year ,anabolic drug or strontium;
- •Patients with contraindications for Zoledronic acid:
- •Patients with invasive malignant tumor on any organ in the past 5 years, treated oruntreated;
- •Patients with primary hyperparathyroidism.
- •Serum calcium >2.75mmol/L (11.0mg/dL).
- •Patients who are unwilling to accept the treatment of Zoledronic acid.
- •Patients who accepted the treatment of investigational product and/or device in the 30 days before randomization.
- •Patients with any medical or mental diseases, which prevent patients from complying with protocols or completing protocols, judged by investigators.
- •Patients with the medical history of inflammation of the iris or uveitis, except the inflammation which is secondary to trauma and cured 2 years ago before screening.
- •Patients with the medical history of diabetic nephropathy or diabetic retinopathy.
- •Patients aged under 60 years old and whose result of urine pregnancy test paper is positive.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Zoledronic acid 5mg
interventional group which receive yearly Zoledronic acid 5mg/100ml infusion treatment for two years
干预措施: Zoledronic acid 5mg (Drug)
结局指标
主要结局
the transverse translation (μm)
时间窗: baseline and month12,month 24
the transverse translation (μm, outside-inside) between acetabular prosthesis markers and reference point
次要结局
- average bone mineral density ( BMD )(1w,6m,12m and 24m after THA operation)