NCT00386360已完成3 期
A Non-Invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D-Peripheral Quantitative Computed Tomography (3D-pQCT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12
研究概览
简要总结
The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral Quantitative Computed Tomography) technology to detect minute changes in bone microarchitecture.
详细描述
The 3D-pQCT equipment allows the evaluation of changes occurring within the bone at "microarchitecture" level, without the need for invasive bone biopsies. The primary objective is to evaluate the sensitivity of the technology to detect a difference between those treated with risedronate 35mg OAW (once a week) or placebo. Early phase postmenopausal women with osteopenia have been chosen because they have a more rapid and higher level of bone loss during the first few years of the menopause.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •cessation of menstruation (surgical or natural) between 6 and 36 months prior to study enrollment;
- •osteopenic
- •must have at least 1 evaluable radius and tibia, without history of fracture (traumatic or atraumatic)
- •BMI (body mass index) between 18 and 28 kg/m2 inclusive;
排除标准
- •history of any generalized bone disease, including hyperparathyroidism, Paget's disease of bone, renal osteodystrophy, or any other acquired or congenital bone disease; or any known condition that would interfere with the assessment of DXA (dual-energy X-ray absorptiometry) at either the lumbar spine (3 non-evaluable lumbar vertebrae at lumbar spine L1 - L4) or the femoral neck.
- •clinical or radiological evidence of osteoporosis, such as atraumatic vertebral compression fracture (* 20% reduction in anterior-to-posterior or middle-to-posterior height ratio; or 20% reduction of the anterior, middle, and/or posterior height as compared with the adjacent vertebrae) documented by spinal X ray or a history of osteoporosis-related atraumatic fracture of the hip or of the wrist;
- •glucocorticoid-induced osteopenia;
- •previous bisphosphonate therapy;
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo dose
干预措施: Placebo comparator (Drug)
Risedronate
Experimental
35 mg risedronate, orally, once weekly
干预措施: risedronate (Drug)
结局指标
主要结局
Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12
时间窗: Baseline and Month 12
次要结局
- Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12(Baseline and Month 12)
- Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12(Baseline and Month 12)
- Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12(Baseline and Month 12)
- Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12(Baseline and Month 12)
- Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12(Baseline and Month 12)
- Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12(Baseline and Month 12)
- Lumbar Spine BMD, Percent Change From Baseline to Month 12(Baseline and Month 12)
- Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12(Baseline and Month 12)
- Femoral Neck BMD, Percent Change From Baseline to Month 12(Baseline and Month 12)
- Greater Trochanter BMD, Percent Change From Baseline to Month 12(Baseline and Month 12)
- Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12(Baseline and Month 12)
- Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12(Baseline and Month 12)
- Height, Percent Change From Baseline to Month 12(Baseline and Month 12)
研究者
研究点 (1)
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