Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Serum Osteocalcin
研究概览
简要总结
Oral and nasal steroids may enhance osteoporosis by suppressing bone formation. Intra-articular steroids may also suppress bone formation, however, the duration or relationship to a steroid dose has not been established. It is hypothesized that intra-articular steroids suppress bone formation transiently, returning to pretreatment levels within four weeks in subjects with osteoarthritis.
详细描述
Oral and nasal steroids may enhance osteoporosis by suppressing bone formation. Intra-articular steroids may also suppress bone formation, however, the duration or relationship to a steroid dose has not been established. It is hypothesized that intra-articular steroids suppress bone formation transiently, returning to pretreatment levels within four weeks in subjects with osteoarthritis. The purpose of the study is to determine if intra-articular steroids suppress markers of bone formation or resorption in osteoarthritis patients and whether these markers may be modified by Vitamin D or Dual-energy X-ray absorptiometry (DEXA) bone density status
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 40 years
- •Male or postmenopausal female
- •Diagnosis of knee osteoarthritis
- •DEXA bone density done within the past 12 months
- •Painful knee, visual analogue scale (VAS) > 4 of (10=worst)
排除标准
- •Diabetes Mellitus Type I or II
- •Systemic inflammatory illness
- •Systemic infections which may be aggravated by steroid therapy
- •No current or previous (< 3 years) biphosphate therapy
- •Previous knee replacement surgery
- •No current or previous Parathyroid hormone (PTH) therapy
研究组 & 干预措施
1
Methylprednisone 80 mg and Lidocaine 20 mg
干预措施: Methylprednisolone and Lidocaine (Drug)
2
Methylprednisolone 16 mg and Lidocaine 20 mg
干预措施: Methylprednisolone and Lidocaine (Drug)
3
Placebo and Lidocaine 20 mg
干预措施: Placebo and Lidocaine (Drug)
结局指标
主要结局
Change in Serum Osteocalcin
时间窗: Change from Baseline Visit to Day 28
Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.
Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)
时间窗: Change from Baseline Visit to Day 28
Outcome represents the mean change in serum biomarkers of bone breakdown (TRACP-5b) from baseline visit to day 28.
次要结局
- Change in Testosterone(Change from Baseline Visit to Day 28)
- Change in Serum Cortisol(Change from Baseline Visit to Day 28)