Clinical trial NCT01824797: Bone Metabolism After Bariatric Surgery
Official title: Determining Changes in Bone Metabolism After Bariatric Surgery in Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Osteoporosis
Keywords: Bone mineral density
sleeve gastrectomy
roux-en-y
postmenopausal females
bone loss
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Society of American Gastrointestinal and Endoscopic Surgeons
First posted: 2013-04-05
Enrollment: 42
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal females scheduled to undergo Roux-en-Y gastric bypass or Sleeve Gastrectomy.

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Bone Mineral Density
timeFrame: Baseline to one year postoperative
Secondary outcomes:
measure: Biochemical Changes in Bone Metabolism
timeFrame: Baseline to one year postoperative
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Center for Metabolic and Weight Loss Surgery
state: North Carolina
Study officials:
affiliation: Duke University
name: Daniel Guerron, MD
role: PRINCIPAL_INVESTIGATOR
References: