Phase 2 Study of Patients Undergoing Bariatric Surgery (Laparoscopic Gastric Bypass) and Evaluation of Bone Metabolism With/Without Vitamin D/Calcium Supplementation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Evaluation of bone mineral density changes in obese patients after laparoscopic bariatric surgery
研究概览
简要总结
Bariatric surgery leads to rapid weight loss in female and male patients. Less data are available about its impact on bone metabolism.
The aim of this study is the investigation of changes in bone mineral density,bone histomorphometric changes, serum bone turnover markers and changes in body fat and muscle composition in patients after laparoscopic gastric bypass surgery.
详细描述
Obese female and male adult patients eligible for laparoscopic gastric bypass surgery according to the national Austrian guidelines will be included in this study upon request and after patient approval.
Baseline data collection and quarterly follow up visits are planned to investigate the changes in bone mineral density and body composition measured by dual energy X-ray absorptiometry as well as the evaluation of serum bone turnover markers of bone formation and resorption.
After surgery subjects will be randomized into two groups:
Daily oral calcium (500mg) and weekly vitamin D3 supplementation (16.000 IU calciferol)or no supplementation of calcium and calciferol.
A sub-study (approximately 15% of study population) with transiliac bone biopsies will also be performed to investigate histomorphometric and histologic changes in bone (biopsy baseline and after 24 months).
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •body mass index >35
- •female and male patients
- •age 18 - 65 years
- •eligible for laparoscopic gastric bypass surgery according to the Austrian national guidelines
排除标准
- •any history of malignancy except basalioma
- •any prior antiresorptive treatment
- •any prior calcium or vitamin D supplementation
- •any secondary disease affecting bone metabolism
研究组 & 干预措施
Calcium/Vitamin D
All subjects will receive calcium/vitamin D supplementation after laparoscopic bariatric gastric bypass surgery as follows:
daily: 500 mg oral calcium (calcium carbonate) weekly: 16.000 IU oral vitamin D3 (calciferol)
干预措施: Calciferol, calcium carbonate (Drug)
结局指标
主要结局
Evaluation of bone mineral density changes in obese patients after laparoscopic bariatric surgery
时间窗: Evaluation every 6 months for 24 months
Dual energy X-ray absorptiometry (DXA) measurements of bone mineral density at lumbar spine, hip, calcaneus and total body will be performed at baseline and every six months for a period of 24 months. Differences will be evaluated on the outcome with/without daily calcium (500mg) and weekly vitamin D (16.000 IU calciferol) supplementation
次要结局
- Evaluation of changes of serum bone turnover markers in obese patients after laparoscopic bariatric surgery(Evaluation every 3 months for 24 months)
研究者
Dr. Christian Muschitz
Senior Consultant for Internal Medicine
Medical University of Vienna