Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery
Recruiting
Phase 3
Interventional Study
Bone Loss
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 30 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 200 (estimated)
- Sponsor
- Wake Forest University Health Sciences · Other
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About This Trial
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 o…
Trial Locations
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Eligibility 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;
* Know…
Contacts