Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Bariatric Surgery and Skeletal Health

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Elaine W. Yu, Massachusetts General Hospital Identifier:
First received: April 2, 2010
Last updated: September 21, 2011
Last verified: September 2011

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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Changes in bone microarchitecture by high-resolution peripheral quantitative computed tomography (HR-pQCT) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Roux-en-Y gastric bypass surgery
Non-surgical lifestyle weight management


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Elaine W. Yu, Co-investigator, Massachusetts General Hospital Identifier: NCT01098942     History of Changes
Other Study ID Numbers: 2009P001445
Study First Received: April 2, 2010
Last Updated: September 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
bariatric surgery processed this record on March 03, 2015