Using risedronate to prevent bone loss after bariatric surgery
Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery
This study is testing if the medication risedronate can help prevent bone and muscle loss in people who have had bariatric surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT04922333 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if the medication risedronate can effectively reduce bone and muscle loss in patients who have undergone bariatric surgery, specifically vertical sleeve gastrectomy. Participants will be randomized to receive either risedronate or a placebo for six months, with assessments of musculoskeletal outcomes at baseline, six months, and twelve months. The study will utilize advanced imaging techniques and biomarkers to evaluate changes in bone density, muscle function, and other relevant health indicators. The trial will involve up to six visits over the course of one year, including monthly follow-ups to monitor participant health and adherence to the medication regimen.
Who should consider this trial
Good fit: Ideal candidates are middle-aged and older adults (≥40 years) who have undergone sleeve gastrectomy.
Not a fit: Patients with a weight greater than 450 lbs or those currently using osteoporosis medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive treatment option for patients at risk of bone loss following bariatric surgery.
How similar studies have performed: While bisphosphonates have been effective in treating osteoporosis, this specific application for preventing bone loss after bariatric surgery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest School of Medicine — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Kristen Beavers, PhD, MPH, RD — Wake Forest University Health Sciences
- Study coordinator: Kristen Beavers, PhD, MPH, RD
- Email: beaverkm@wfu.edu
- Phone: 336-758-5855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.