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临床试验/NCT01098942
NCT01098942已完成不适用

Effects of Bariatric Surgery on Skeletal Health

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Changes in bone mineral density by dual-energy x-ray absorptiometry (DXA) and quantitative computed tomography (QCT)

研究概览

简要总结

Bone loss may occur after bariatric (weight loss) surgery, but standard methods of measuring bone density in obese patients are potentially inaccurate. This study uses quantitative computed tomography to examine changes in bone mineral density after bariatric surgery. We are also studying mechanisms which may explain bone loss after bariatric surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Either scheduled for Roux-en-Y Gastric Bypass surgery or enrolled in a lifestyle weight management program

排除标准

  • Weight ≥ than 450 lbs
  • Postmenopausal women
  • Significant heart, kidney, liver, or malignant disease
  • Current disorders known to affect bone
  • Use of medications known to affect bone for more than 7 days in the past 12 months

结局指标

主要结局

Changes in bone mineral density by dual-energy x-ray absorptiometry (DXA) and quantitative computed tomography (QCT)

时间窗: 1 year

次要结局

  • Changes in serum and/or urine indices of bone formation and bone resorption, such as aminoterminal propeptide of type I collagen [PINP], osteocalcin, C-telopeptide cross-links [CTX])(1 year)
  • Changes in bone microarchitecture by high-resolution peripheral quantitative computed tomography (HR-pQCT)(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elaine W. Yu

Co-investigator

Massachusetts General Hospital

研究点 (2)

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