Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Percentage Change in Total Hip Bone Mineral Density
研究概览
简要总结
Bariatric surgery leads to bone loss and increases fracture risk. This study evaluates whether denosumab can prevent the high-turnover bone loss that occurs after Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG) surgery.
详细描述
Bariatric surgery is a highly effective weight loss treatment, but one of the unintended side effects of these procedures is high-turnover bone loss and metabolic bone disease. Denosumab is a monoclonal antibody to RANKL that acts as a potent inhibitor of bone resorption. The investigators are conducting a randomized placebo-controlled trial to evaluate the ability of denosumab to prevent bone loss after RYGB or SG surgery in older adults. At the conclusion of the study, all participants will be given zoledronic acid.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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
Denosumab
Denosumab 60mg subcutaneous injection every 6 months
干预措施: Denosumab (Drug)
Denosumab
Denosumab 60mg subcutaneous injection every 6 months
干预措施: Zoledronic Acid (Drug)
Placebo
Placebo subcutaneous injection every 6 months
干预措施: Placebo (Drug)
Placebo
Placebo subcutaneous injection every 6 months
干预措施: Zoledronic Acid (Drug)
结局指标
主要结局
Percentage Change in Total Hip Bone Mineral Density
时间窗: Pre-operative baseline to post-operative month 19
次要结局
未报告次要终点
研究者
Elaine W. Yu
Associate Professor
Massachusetts General Hospital