Status:
COMPLETED
Bone Metabolism After Bariatric Surgery
Lead Sponsor:
Duke University
Collaborating Sponsors:
Society of American Gastrointestinal and Endoscopic Surgeons
Conditions:
Obesity
Osteoporosis
Eligibility:
FEMALE
40+ years
Brief Summary
The purpose and objective of this study is to determine the changes in bone metabolism after bariatric surgery in postmenopausal women. This is a prospective cohort study that will enroll up to 40 po...
Eligibility Criteria
Inclusion
- Postmenopausal women as determined by having a history of no menstrual bleed for greater than one year.
- Body Mass Index ≥35 kg/m² and stable weight for the previous 3 months.
- Able to speak and read English.
- Being scheduled for either Roux-en-Y gastric bypass or sleeve gastrectomy.
Exclusion
- A documented history of osteoporosis or currently receiving medical treatment for osteoporosis with bisphosphonates, teriparatide, raloxifene, or denosumab.
- Weight greater than 295 pounds as this is the weight limit for our Dual-energy X-ray absorptiometry machine.
- Current or past (less than 1 year from enrollment) usage of estrogen hormone replacement therapy.
- Current smoker
- Any history of glucocorticoid use greater than one year in duration or current use of glucocorticoids.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2018
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01824797
Start Date
May 1 2013
End Date
May 31 2018
Last Update
August 16 2019
Active Locations (1)
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1
Duke Center for Metabolic and Weight Loss Surgery
Durham, North Carolina, United States, 27704