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Bariatric Surgery and Skeletal Health

This study is ongoing, but not recruiting participants.
ClinicalTrials.gov Identifier:
First Posted: April 5, 2010
Last Update Posted: April 19, 2017
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.
Information provided by (Responsible Party):
Elaine W. Yu, Massachusetts General Hospital
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.

Morbid Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Bariatric Surgery on Skeletal Health

Resource links provided by NLM:

Further study details as provided by Elaine W. Yu, Massachusetts General Hospital:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: November 2009
Estimated Study Completion Date: November 2017
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Roux-en-Y gastric bypass surgery
Non-surgical lifestyle weight management


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01098942

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Joel S. Finkelstein, MD Massachusetts General Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elaine W. Yu, Co-investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01098942     History of Changes
Other Study ID Numbers: 2009P001445
First Submitted: April 2, 2010
First Posted: April 5, 2010
Last Update Posted: April 19, 2017
Last Verified: April 2017

Keywords provided by Elaine W. Yu, Massachusetts General Hospital:
bariatric surgery

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms