Bone Metabolism After Bariatric Surgery

Obesity Clinical Trial

Official title: Determining Changes in Bone Metabolism After Bariatric Surgery in Postmenopausal Women

Status Completed

Clinical Trial 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 postmenopausal female subjects with class II and III obesity from the Duke Center for Metabolic and Weight Loss Surgery. The study team will enroll subjects that are already being scheduled for either sleeve gastrectomy or Roux-en-Y gastric bypass. The osteoclast activity, the osteoblast activity, and the bone mineral density will be measured in all subjects preoperatively and 12 months postoperatively through research specific blood tests and Dual energy x-ray Absorptiometry (DEXA) scans.

The primary endpoints are change in osteoclast activity as measured by C-terminal telopeptide of type I collagen and change in bone density as measured by DEXA scan. These are continuous variable and given the small sample size the investigators will use a nonparametric Wilcoxon rank-sum test to compare the difference in one year change in these variables. There is a slight risk of loss of confidentiality. Every effort will be made to protect all PHI. There is also the risk of increased exposure to radiation from the DEXA scans performed twice with each subjects participating in the study.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Obesity
• Osteoporosis

• NCT number: NCT01824797
• Study type: Observational
• Source: Duke University
• Status: Completed
• Start date: May 2013
• Completion date: May 31, 2018