Zoledronic Acid for Prevention of Bone Loss After BAriatric Surgery (ZABAS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Quantitative Computed Tomography (QCT)
研究概览
简要总结
In a randomised placebo-controlled trial assess effects of zoledronic acid for prevention of bone and muscle loss after bariatric surgery.
详细描述
In individuals with severe obesity, bariatric surgery effectively reduces body weight, improves obesity related diseases and lowers mortality. A loss of bone and muscle mass and an increase in bone fracture risk are however seen after surgery. In this study it is examined if treatment with zoledronic acid (a drug used to treat osteoporosis) can prevent the bone and muscle loss after bariatric surgery. A single infusion of zoledronic acid or placebo is given before surgery. The study is blinded and randomized for methodological reasons. Bone and muscle scans, tests of muscle strength and physical performance and blood samples (for analysis of markers related to bone and muscle metabolism) are performed at inclusion and 12 and 24 months after surgery. A total of 60 adult individuals will participate. Results will be important for the evidence-based care of patients undergoing bariatric surgery and zoledronic acid.
Study design This is a single center randomized double-blind placebo-controlled study of zoledronic acid for prevention of bone and muscle loss after bariatric surgery. Routine bariatric surgery (RYGB or gastric sleeve) will be performed. The end of study is 24 months after surgery.
Study Population Patients referred for bariatric surgery at The Hospital South West Jutland, Esbjerg will be invited to participate.
Randomization After inclusion and baseline assessment, patients will be randomly assigned to either zoledronic acid or placebo with a 1:1 allocation. A randomization code stratifying an equal number of participants having RYGB or SG into each study arm will be applied.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •35 years old or older
- •Eligible for bariatric surgery (BMI>35 kg/m2 with obesity-related comorbidity)
排除标准
- •Pregnancy or breastfeeding.
- •Chronic kidney disease with estimated GFR<45 ml/min.
- •Hypocalcemia .
- •Hypersensitivity to bisphosphonates, mannitol, sodium citrate or water.
- •Metabolic bone disease (osteoporosis is allowed).
- •Prior treatment with anti-osteoporotic agents.
- •Treatment with oral glucocorticoids
- •Other diseases with known effects on bone metabolism
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Zoledronic Acid
Active treatment
干预措施: Zoledronic Acid (Drug)
结局指标
主要结局
Quantitative Computed Tomography (QCT)
时间窗: Change from baseline to 12 and 24 months after bariatric surgery
Volumetric bone mineral density at the lumbar spine (L1 -L2) (Mindways QCT Pro software, Texas, USA).
次要结局
- Biochemical calcium-metabolic markers(Change from baseline to 12 and 24 months after bariatric surgery)
- Cortical bone stiffness(Change from baseline to 12 and 24 months after bariatric surgery)
- Muscle Strength(Change from baseline to 12 and 24 months after bariatric surgery)
- QCT(Change from baseline to 12 and 24 months after bariatric surgery)
- DEXA(Change from baseline to 12 and 24 months after bariatric surgery)
- HR-pQCT(Change from baseline to 12 and 24 months after bariatric surgery)
- Physical function(Change from baseline to 12 and 24 months after bariatric surgery)
研究者
Stinus Gadegaard Hansen
Endocrinologist, Associate professor, PhD
Esbjerg Hospital - University Hospital of Southern Denmark