Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery
Wake Forest University Health Sciences
Summary
The purpose of this research study is to see whether receiving a bisphosphonate medication called risedronate can reduce bone and muscle loss following bariatric surgery. Participation will involve up to 6 study visits and last about 1 year. Risedronate is a medication that prevents bone breakdown and has been approved by the US Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis in older men and women. However, risedronate has not been approved for the prevention of bone and muscle loss following vertical sleeve gastrectomy. Participation in this study will involve completing two visits before beginning the intervention. Participants who qualify will be scheduled to begin the intervention program which will involve taking 6 monthly doses of a risedronate or placebo pill. Participants will then receive monthly contacts by study staff during this time to remind participants to take the intervention pill and ask about any adverse events. After the completion of intervention period, participants will complete up to 4 follow up study visits at 6 months (2 visits) and at 12 months (2 visits).
Description
The main objective of the proposed study is to definitively test whether risedronate use can effectively counter SG associated bone loss. To do this, we propose to randomize 120 middle-aged and older (≥40 years) SG patients to six months of risedronate or placebo treatment, with musculoskeletal outcomes assessed at baseline, six, and 12 months. Due to its robust change following SG and clinical utility in predicting fracture, our primary outcome is change in total hip areal (a)BMD measured by dual energy x-ray absorptiometry (DXA). This will be complemented by DXA-acquired aBMD assessment at o…
Eligibility
- Age range
- 30+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects who have had sleeve gastrectomy * Willing to provide informed consent * Agree to all study procedures and assessments. Exclusion Criteria: * Weight greater than 450 lbs * Regular use of growth hormones, oral steroids, or prescription osteoporosis medications; * Known allergies to bisphosphonates * Unstable gastric reflux requiring two or more additional doses per month of anti-reflux medication. * Current participation in other research study * Unable to provide own transportation to study visits * Unable to position on scanner independently.
Interventions
- DrugRisedronate
150mg over-encapsulated risedronate
- DrugPlacebo
Capsules containing placebo tablets
Location
- Wake Forest School of MedicineWinston-Salem, North Carolina