Overview

This trial is active, not recruiting.

Condition morbid obesity
Sponsor Massachusetts General Hospital
Start date November 2009
End date August 2012
Trial size 50 participants
Trial identifier NCT01098942, 2009P001445

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Roux-en-Y gastric bypass surgery
Non-surgical lifestyle weight management

Primary Outcomes

Measure
Changes in bone mineral density by dual-energy x-ray absorptiometry (DXA) and quantitative computed tomography (QCT)
time frame: 1 year

Secondary Outcomes

Measure
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])
time frame: 1 year
Changes in bone microarchitecture by high-resolution peripheral quantitative computed tomography (HR-pQCT)
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effects of Bariatric Surgery on Skeletal Health
Principal investigator Joel S. Finkelstein, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.