Bone Metabolism After Bariatric Surgery

Obesity Clinical Trial

Official title:

Determining Changes in Bone Metabolism After Bariatric Surgery in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824797
• Other study ID #: Pro00044248
• Status: Completed
• Start date: May 2013
• Est. completion date: May 31, 2018

Study information

• Verified date: August 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Postmenopausal women as determined by having a history of no menstrual bleed for greater than one year.

2. Body Mass Index =35 kg/m² and stable weight for the previous 3 months.

3. Able to speak and read English.

4. Being scheduled for either Roux-en-Y gastric bypass or sleeve gastrectomy.

Exclusion Criteria:

1. A documented history of osteoporosis or currently receiving medical treatment for osteoporosis with bisphosphonates, teriparatide, raloxifene, or denosumab.

2. Weight greater than 295 pounds as this is the weight limit for our Dual-energy X-ray absorptiometry machine.

3. Current or past (less than 1 year from enrollment) usage of estrogen hormone replacement therapy.

4. Current smoker

5. Any history of glucocorticoid use greater than one year in duration or current use of glucocorticoids.

Related Conditions & MeSH terms

• Obesity
• Osteoporosis

Locations

Country	Name	City	State
United States	Duke Center for Metabolic and Weight Loss Surgery	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Society of American Gastrointestinal and Endoscopic Surgeons

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Bone Mineral Density	Changes in bone mineral density will be determined by comparing a peroperative DEXA scan with a one year postoperative DEXA scan on postmenopausal subjects who have already planned to undergo Roux-en-Y gastric bypass or sleeve gastrectomy.	Baseline to one year postoperative
Secondary	Biochemical Changes in Bone Metabolism	Serum will be collected 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.	Baseline to one year postoperative

External Links

•   Luhrs, A.R., Davalos, G., Lerebours, R. et al. Surg Endosc (2019)