MedPath

Bariatric Surgery and Skeletal Health

Completed
Conditions
Morbid Obesity
Registration Number
NCT01098942
Lead Sponsor
Massachusetts General Hospital
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
Inclusion Criteria
  • Either scheduled for Roux-en-Y Gastric Bypass surgery or enrolled in a lifestyle weight management program
Exclusion Criteria
  • 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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes in bone mineral density by dual-energy x-ray absorptiometry (DXA) and quantitative computed tomography (QCT)1 year
Secondary Outcome Measures
NameTimeMethod
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

Trial Locations

Locations (2)

MGH

🇺🇸

Boston, Massachusetts, United States

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

© Copyright 2025. All Rights Reserved by MedPath