NCT04922333 · Wake Forest University Health Sciences
Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery
What this study is about
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.
View original scientific description
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).
Interventions
DRUG
Risedronate
150mg over-encapsulated risedronate
DRUG
Placebo
Capsules containing placebo tablets
Primary outcome measures
Change in Total Hip Areal Bone Mineral Density (aBMD)
Time frame: baseline through Month 6
Acquired through DXA scans.
Change in Total Hip Areal Bone Mineral Density (aBMD)
Time frame: baseline through Month 12
Acquired through DXA scans.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Winston-Salem, North Carolina
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 19, 2026 · Source of record for eligibility and locations