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Bariatric Surgery and Skeletal Health

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Elaine W. Yu, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01098942
First received: April 2, 2010
Last updated: September 21, 2011
Last verified: September 2011
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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)
Groups/Cohorts
Surgical
Roux-en-Y gastric bypass surgery
Non-surgical
Non-surgical lifestyle weight management

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Elaine W. Yu, Co-investigator, Massachusetts General Hospital
ClinicalTrials.gov 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

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

ClinicalTrials.gov processed this record on June 18, 2013