Bariatric Surgery and Skeletal Health

Effects of Bariatric Surgery on Skeletal Health

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01098942

Enrollment

Registered

2010-04-05

Start date

2009-11-30

Completion date

2018-03-31

Last updated

2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Keywords

bariatric surgery

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results