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Bariatric Surgery and Skeletal Health

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ClinicalTrials.gov Identifier: NCT01098942
Recruitment Status : Completed
First Posted : April 5, 2010
Last Update Posted : March 21, 2018
Sponsor:
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

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

U.S. FDA Resources

Group/Cohort
Surgical
Roux-en-Y gastric bypass surgery
Non-surgical
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 ]


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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01098942


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
MGH
Boston, Massachusetts, United States
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Joel S. Finkelstein, MD Massachusetts General Hospital

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 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:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms