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Bone metabolism

Study to examine changes in bone metabolism after surgery

STudy will compare bone metabolism in sleeve and bypass patients

Duke University is heading a study that will determine the changes in bone metabolism after bariatric surgery in postmenopausal women. The study, which will be supported by the Society of American Gastrointestinal Endoscopic Surgeons (SAGES), will enrol up to 40 postmenopausal female subjects with class II and III obesity from the Duke Center for Metabolic and Weight Loss Surgery.

The study team will recruite subjects that are already being scheduled for either sleeve gastrectomy or Roux-en-Y gastric bypass, and will measure osteoclast activity, the osteoblast activity, and the bone mineral density in all subjects preoperatively and 12 months postoperatively through research specific blood tests and Dual energy x-ray Absorptiometry (DEXA) scans.

The primary endpoints of the ‘Determining changes in bone metabolism after bariatric surgery in postmenopausal women’ study, are changes in osteoclast activity as measured by C-terminal telopeptide of type I collagen and change in bone density as measured by DEXA scan.

As the study will include a small number of patients, the investigators will use a non-parametric Wilcoxon rank-sum test to compare the difference in one year change in these variables. The principal investigator of the study is Dr Alfonso Torquati from Duke University.

Secondary outcome measures include biochemical changes in bone, which will be determined by collecting serum from the subjects preoperatively and 12 months postoperatively. The serum will be used at the completion of the study to run enzyme-linked immunosorbent assay (ELISA) to determine biochemical changes in their bone metabolism.

The study is expected to be completed in June 2014.

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