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New treatment option for Bone Loss
Official title Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery
ClinicalTrials.gov ID: NCT04922333
What this study is testing
What is Risedronate?
Risedronate is an investigational medicine, given as a monthly pill taken by mouth, being studied as a potential treatment for bone loss.
Also referred to as Actonel, Atelvia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older
You may be able to join if
- people who have had sleeve gastrectomy
- Willing to provide informed consent
- Agree to all study procedures and assessments.
You likely can't join if
- 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
See the full eligibility criteria
- people who have had sleeve gastrectomy
- Willing to provide informed consent
- Agree to all study procedures and assessments.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.