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NCT01098942 Clinical Trial

Bariatric Surgery and Skeletal Health

Morbid Obesity Clinical Trial

Official title:
Effects of Bariatric Surgery on Skeletal Health

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01098942
Other study ID # 2009P001445
Secondary ID
Status Completed
Phase
First received April 2, 2010
Last updated March 20, 2018
Start date November 2009
Est. completion date March 2018

Study information
Verified date March 2018
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 2018
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts
United States MGH Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in bone mineral density by dual-energy x-ray absorptiometry (DXA) and quantitative computed tomography (QCT) 1 year
Secondary 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
Secondary Changes in bone microarchitecture by high-resolution peripheral quantitative computed tomography (HR-pQCT) 1 year
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