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Bariatric Surgery and Skeletal Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01098942
Recruitment Status : Completed
First Posted : April 5, 2010
Last Update Posted : March 21, 2018
Information provided by (Responsible Party):
Elaine W. Yu, 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.

Condition or disease
Morbid Obesity

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Bariatric Surgery on Skeletal Health
Study Start Date : November 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Roux-en-Y gastric bypass surgery
Non-surgical lifestyle weight management

Primary Outcome Measures :
  1. Changes in bone mineral density by dual-energy x-ray absorptiometry (DXA) and quantitative computed tomography (QCT) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]
  2. Changes in bone microarchitecture by high-resolution peripheral quantitative computed tomography (HR-pQCT) [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Obese adults

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01098942

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Joel S. Finkelstein, MD Massachusetts General Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Elaine W. Yu, Co-investigator, Massachusetts General Hospital Identifier: NCT01098942    
Other Study ID Numbers: 2009P001445
First Posted: April 5, 2010    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Keywords provided by Elaine W. Yu, Massachusetts General Hospital:
bariatric surgery
Additional relevant MeSH terms:
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Obesity, Morbid
Nutrition Disorders
Body Weight