A Randomized, Double-blind Study to Evaluate the Effect of Once Monthly Bonviva on Lumbar Bone Mineral Density in the Prevention of Glucocorticoid-induced Osteoporosis in Post-menopausal Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
研究概览
简要总结
This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •post-menopausal women, 50-85 years of age;
- •any inflammatory rheumatoid disease including polymyalgia rheumatica;
- •receiving treatment with 5-15 mg/day of prednisolone.
排除标准
- •previous treatment with an iv bisphosphonate at any time;
- •previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within last year, or >3 months of treatment within last 2 years;
- •treatment with parathyroid hormone in last 2 years;
- •inability to stand or sit in an upright position for at least 60 minutes;
- •inability to swallow a tablet whole;
- •history of major gastrointestinal disease.
研究组 & 干预措施
Ibandronate
Participants received monthly oral ibandronate (150 milligrams [mg]) for 12 months.
干预措施: ibandronate (Drug)
Placebo
Participants received monthly oral placebo for 12 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
时间窗: Baseline and Month 12
Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance.
次要结局
- Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6(Baseline and Month 6)
- Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12(Baseline and Months 1, 6 and 12)
- Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months(Month 6)
- Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12(Baseline and Months 6 and 12)