Bariatric Surgery and Skeletal Health
Effects of Bariatric Surgery on Skeletal Health
1 other identifier
observational
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2009
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 2, 2010
CompletedFirst Posted
Study publicly available on registry
April 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedMarch 21, 2018
March 1, 2018
2.8 years
April 2, 2010
March 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in bone mineral density by dual-energy x-ray absorptiometry (DXA) and quantitative computed tomography (QCT)
1 year
Secondary Outcomes (2)
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])
1 year
Changes in bone microarchitecture by high-resolution peripheral quantitative computed tomography (HR-pQCT)
1 year
Study Arms (2)
Surgical
Roux-en-Y gastric bypass surgery
Non-surgical
Non-surgical lifestyle weight management
Eligibility Criteria
Obese adults
You may qualify if:
- Either scheduled for Roux-en-Y Gastric Bypass surgery or enrolled in a lifestyle weight management program
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MGH
Boston, Massachusetts, United States
Related Publications (2)
Yu EW, Bouxsein ML, Putman MS, Monis EL, Roy AE, Pratt JS, Butsch WS, Finkelstein JS. Two-year changes in bone density after Roux-en-Y gastric bypass surgery. J Clin Endocrinol Metab. 2015 Apr;100(4):1452-9. doi: 10.1210/jc.2014-4341. Epub 2015 Feb 3.
PMID: 25646793DERIVEDYu EW, Bouxsein ML, Roy AE, Baldwin C, Cange A, Neer RM, Kaplan LM, Finkelstein JS. Bone loss after bariatric surgery: discordant results between DXA and QCT bone density. J Bone Miner Res. 2014 Mar;29(3):542-50. doi: 10.1002/jbmr.2063.
PMID: 23929784DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joel S. Finkelstein, MD
Massachusetts General Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-investigator
Study Record Dates
First Submitted
April 2, 2010
First Posted
April 5, 2010
Study Start
November 1, 2009
Primary Completion
August 1, 2012
Study Completion
March 1, 2018
Last Updated
March 21, 2018
Record last verified: 2018-03