NCT01360424已完成4 期
Efficacy of Teriparatide Treatment in Patients With New Forms of Inherited Low-Turnover Osteoporosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change from baseline in lumbar bone mineral density (BMD)
研究概览
简要总结
The purpose of this study is to analyse efficacy of teriparatide treatment in patients with new forms of inherited low-turnover osteoporosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inherited low-turnover osteoporosis
- •lumbar spine or hip BMD T-score ≤ -2.5
- •a written informed consent.
排除标准
- •age less than 18 years
- •generally accepted contraindications for the treatment
研究组 & 干预措施
teriparatide
Experimental
干预措施: Teriparatide (Drug)
结局指标
主要结局
Change from baseline in lumbar bone mineral density (BMD)
时间窗: 0, 12 and 24 months
The primary outcome measure is the change in lumbar BMD measured with dual-energy X-ray absorptiometry (DXA) during the 24 months treatment period.
次要结局
- Change from baseline in whole body bone mineral density (DXA)(0,12 and 24 months)
- Change from baseline in hip bone mineral density (DXA)(0,12 and 24 months)
- Change from baseline in histomorphometry of bone biopsy samples(0 and 24 months)
- Change from baseline in bone microarchitecture assessed by micro computed tomography of bone biopsy samples(0 and 24 months)
- Change from baseline in peripheral quantitative computed tomography (pQCT) measured cortical and trabecular volumetric bone mineral density of tibia and radius(0,12 and 24 months)
- Number of vertebral fractures (spine X-ray)(24 months)
- Change from baseline in serum procollagen type I N-terminal propeptide (PINP)(0,3,6,12 and 24 months)
- Change from baseline in serum type I collagen C-telopeptides (CTX)(0,3,6,12 and 24 months)
- Change from baseline in serum osteocalcin(0,3,6,12 and 24 months)
研究者
Ville-Valtteri Välimäki
Dr
Helsinki University Central Hospital
研究点 (1)
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