Non-Invasive Assessment of Bone Micro-architecture and Strength Changes in Men With Osteopenia and Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Measure cross-sectional and longitudinal differences in bone micro-architecture and strength changes in men with BMD T-scores ≤-2.0 and those with T-scores >-1.0.
研究概览
简要总结
In the context of male osteoporosis, we hypothesize that regional changes in trabecular bone, as well as changes in cortical porosity will play a major role, and thus also affect bone strength. In developing therapeutics the response of individual compartments, regional variations post-therapy will have considerable impact on selecting the therapies as well as monitoring response to therapy. This study, a precursor to other therapeutic trials, will lay the ground-work for the future.
详细描述
We will recruit 80 subjects who will be stratified into groups based on their T-scores. All subjects will be imaged at Baseline and 12 months. Measures of bone micro-architecture in the tibia and radius using peripheral computed tomography, bone strength measures through finite element analysis will be obtained at all time points. DXA measures at the spine, femur and forearm will be obtained as reference measures. In addition whole body DXA scans will be performed for assessment of body composition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men 50-85 years old
- •Patients must be willing to undergo a DXA scan.
- •Patients should be willing to undergo HRpQCT scan of the radius and tibia.
排除标准
- •Inability to tolerate CT scans
- •Use of medications known to impact bone and mineral metabolism:
- •use of a bisphosphonate or teriparatide in the last year or for >12 months ever;
- •current calcitonin;
- •prednisone >5 mg daily or the equivalent glucocorticoid for >10 days in the last 3 months;
- •current testosterone therapy;
- •current thiazolidinedione (TZD);
- •current androgen deprivation therapy;
- •current use of an antiepileptic agent that alters hepatic vitamin D clearance;
- •use of thyroid hormone replacement with current thyroid stimulating hormone <0.1 mIU/L
- •Disease known to affect bone (e.g., primary hyperparathyroidism, Pagets disease, clinically significant liver disease)
- •Illicit drug use or alcohol use >3 drinks/day
- •Serum calcium >10.2 mg/dL or calculated creatinine clearance <30 mL/min
- •Weight >350 pounds (the maximum weight limit of the DXA)
- •Hardware in the lumbar spine
- •History of bilateral hip replacement, or bilateral wrist or ankle fracture
结局指标
主要结局
Measure cross-sectional and longitudinal differences in bone micro-architecture and strength changes in men with BMD T-scores ≤-2.0 and those with T-scores >-1.0.
时间窗: 12 months
Trabecular bone micro-architecture as measured by trabecular number, trabecular BMD, and trabecular bone volume fraction (BV/TV). Cortical bone micro-architecture will be assessed by measuring cortical density \& thickness and porosity.
次要结局
- Change in Compressive biomechanical bone properties from Baseline to 12 months(12 months)
- Association between BMD, bone micro-architecture, compressive biomechanical properties and body composition at all timepoints(Baseline and 12 months)