Bone Metabolism After Bariatric Surgery
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Osteoporosis |
| Therapuetic Areas: | Endocrinology, Rheumatology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 8/15/2018 |
| Start Date: | May 2013 |
| End Date: | May 31, 2018 |
Determining Changes in Bone Metabolism After Bariatric Surgery in Postmenopausal Women
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.
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.
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.
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