NCT00397839已完成3 期
A Parallel, Placebo-controlled, Randomized (2:1) Double-blind Study of One Year Duration to Assess the Effect of Oral Ibandronate 150 mg Given Once-monthly Versus Placebo on LS BMD in Men With Osteoporosis
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
- 135
- 试验地点
- 1
- 主要终点
- Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12
研究概览
简要总结
Male osteoporosis is a common and important clinical problem, associated with significant morbidity, mortality and societal expense. Approximately 10% of men =65 years of age are osteoporotic. The proposed study will evaluate efficacy and safety of oral ibandronate given 150 mg once-monthly for 12 months versus placebo in men with primary osteoporosis. Less frequent, once monthly, dosing is expected to improve patient's treatment adherence compared to a weekly dosing regimen.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: placebo (Drug)
Ibandronate
Experimental
干预措施: Ibandronate (Drug)
结局指标
主要结局
Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12
时间窗: 12 months
BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
次要结局
- Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6(6 months)
- Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12(12 months)
- Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6(6 months)
- Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months(12 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Efficacy and Safety of Ginseng Extract on Improvement of Bone Metabolism in Menopausal WomenOsteopeniaNCT02763280Chonbuk National University Hospital90
已完成
4 期
Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis TreatmentOsteoporosisNCT02371252Mahidol University140
已完成
3 期
Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary HypogonadismEffect of Treatment on Bone Mineral DensityNCT01619683Repros Therapeutics Inc.300
已完成
3 期
Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and OlderOsteopeniaNCT00132808Novartis Pharmaceuticals581
终止
3 期
Low-Dose Hormone Replacement Therapy and Alendronate for OsteoporosisOsteopeniaOsteoporosisNCT00000430National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)240