The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Bone Mineral Density (BMD)
研究概览
简要总结
Osteogenesis imperfecta (OI) is an inherited disease of the connective tissue. Symptoms are fractures, growth retardation, blue sclera, bad teeth, impaired hearing a.o. The aim of the present study is to investigate the effect of treatment of adult OI patients with bisphosphonate (zoledronic acid), parathyroid hormone (PTH) or placebo on bone mass, fracture risk and quality of life.
The investigators will therefore conduct a double blind, placebo controlled trial, taking genotype and previous antiresorptive therapy into account.
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
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of osteogenesis imperfecta
- •BMD<-1.0 or
排除标准
- •creatinine clearance <30mL/min
- •treatment with glucocorticoids > 5mg daily during the last 3 months
- •metabolic bone disease or vitamin d deficiency
- •liver or kidney disease
- •contradictions to zoledronic acid or teriparatide
- •increased baseline risk of osteosarcoma
研究组 & 干预措施
Zolendronic acid, 3 yr + placebo teriparatide, 2 yr
yearly intravenous infusion of 5mg active zoledronic acid in 3 yr
干预措施: Zoledronic acid (Drug)
teriparatide 2 yr; active zol in 3rd yr
daily injection of one dose active teriparatide for two years, active zoledronic acid in year 3.
干预措施: Zoledronic acid (Drug)
teriparatide 2 yr; active zol in 3rd yr
daily injection of one dose active teriparatide for two years, active zoledronic acid in year 3.
干预措施: Teriparatide (Drug)
No active treatment
Observation in three years, no treatment
干预措施: No active treatment (Other)
结局指标
主要结局
Bone Mineral Density (BMD)
时间窗: Three years
Dual-energy X-ray absorptiometry scans are performed at the lumbar spine, hip and whole body twice yearly. The value of the lumbar BMD is the primary outcome.
次要结局
- Fracture risk(Three years)